A Multicenter, Randomized, Open Label, Controlled Study Evaluating the Effectiveness and Safety of Furoscix On-Body Infusor vs Continued Medical Therapy for Worsening Heart Failure
Phase: PHASE2
Conditions: Heart Failure
Sponsor: scPharmaceuticals, Inc.

 
 
 
 
STUDY PROTOCOL 
 
Avoiding Treatment in the Hospital with Furoscix for the 
Management of Congestion in Heart Failure – A Pilot Study  
AT HOME-HF Pilot 
 
A Multicenter, Randomized, Open Label, Controlled Study 
Evaluating the Effectiveness and Safety of Furoscix® On-Body 
Infusor vs Continued Medical Therapy for Worsening Heart 
Failure 
 
 
IND Number: 
118919 
Protocol Number:  
scP-01-008 
Study Type: 
Phase II 
Investigational Drug-
Device Combination:  
Furoscix® On-Body Infusor 
Original Protocol Date: 
25 June 2020 
Amendment 1 Date: 
04 November 2020 
Amendment 2 Date: 
Amendment 3 Date: 
Amendment 4 Date: 
08 December 2020 
10 February 2021 
30 April 2021 
Amendment 5 Date: 
09 December 2021 
CONFIDENTIAL STATEMENT 
The information contained in this document and all information provided to you related 
to Furoscix On-Body Infusor is the confidential and proprietary information of 
scPharmaceuticals, Inc. (Sponsor) and except as may be required by federal, state or 
local laws or regulations, may not be disclosed to others without prior written 
permission of the Sponsor.  The Principal Investigator may, however, disclose such 
information to supervised individuals working on this protocol, provided such 
individuals agree to maintain the confidentiality of such information. 

scPharmaceuticals, Inc. 
 
Protocol scP-01-008 
AT HOME-HF Pilot 
 
 
 
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PRINCIPAL INVESTIGATORS 
 
Marvin A. Konstam, MD 
Chief Physician Executive, The CardioVascular Center 
Tufts Medical Center 
800 Washington Street  
Boston, MA 02111 
 
James E Udelson, MD 
Chief, Division of Cardiology 
Tufts Medical Center 
800 Washington Street 
Boston, MA 02111 
 
SPONSOR CONTACT INFORMATION 
 
John Mohr, Pharm.D., FIDP 
Sr. Vice President Clinical Development and Medical Affairs 
2400 District Avenue, Suite 310 
Burlington, MA 01803 
Phone: (781) 301-7220 
Fax: (857) 445-4834 
Cell: (281) 658-7949 
 
 

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SUMMARY OF CHANGES 
 
Amendment 1: The protocol has been updated to clarify scheduling of weekend study visits, add 
designee to study staff and administrative changes. It also clarifies capturing AEs for both groups, 
removal of “treatment emergent” adverse events and rewording instruction for Dyspnea Status - 7-
Point Likert Scale for both study groups. The details of the changes are summarized in the table 
below. 
Amendment 2: The protocol has been amended to clarify that a centralized lab will be used for NT-
proBNP analysis. It also includes administrative changes to Screening (Day 0) to align Time and 
Events Schedule to assess AEs and record medications taken within 48 hours.  
Amendment 3: The protocol has been amended to remove that the device can be applied before 
leaving the clinic and started at home. The device should be applied and started without delay 
according to the Instructions for Use. It specifies that the initial dose of the study product may be 
administered in the clinic or at home on the day of enrollment. 
Amendment 4: The protocol has been amended to clarify primary endpoint change in NT-proBNP 
from baseline at Day 7 and add AEs and add secondary endpoint of % Lung Fluid Measurement via 
Remote Dielectric Sensing (ReDS).  It also includes recording device issues, removes Adverse 
Reaction and Suspected Adverse Reaction definitions, defines AEs of Special Interest, updates 
statistical analysis, increases number of subjects from 50 to 51 and minor administrative changes. 
Amendment 5: The protocol has been amended to add a NT-proBNP assessment on Day 3 clinic 
visit, clarify 51 subjects will be included, remove the upper age limit of 80 years from inclusion criteria 
and align populations for analysis with the statistical analysis plan. 
 
Version 
Date 
Page 
Change 
Reason for Change 
Original 
25 Jun 2020 
N/A 
Original Version 
New Document 
Amendment 1 
04 Nov 2020 
Synopsis, Subject 
Population p. 9, 
Section 4.2 
Exclusion Criteria  
p. 24. 
Added “IV” 
bumetanide in 
exclusion criteria. 
Added “IV” to specify 
bumetanide 
administration route. 
Amendment 1 
04 Nov 2020 
Synopsis, Study 
Assessments and 
Procedures p. 10,  
Section 1.2.3 Risk 
Management p. 18. 
Added “or 
designee”. 
Added “or designee” to 
include additional site 
staff can be designated 
to make phone calls. 
Amendment 1 
04 Nov 2020 
Section 6.2 p. 28, 
Section 6.2.5 p. 31, 
Section 11.1 
Appendix 1: Time 
and Events 
Schedule p. 52. 
Added “If Day 3 falls 
on a Saturday or 
Sunday, subjects 
may be seen in the 
clinic and have Day 
3 assessments 
completed on either 
Day 2 (Friday, if Day 
3 falls on Saturday) 
or Day 4 (Monday, if 
Day 3 falls on 
Sunday).  On Day 3 
the subject will have 
a phone call visit.” 
Added to clarify 
scheduling of weekend 
visits. 
Amendment 1 
04 Nov 2020 
Section 6.2.2 p. 30.  
 
Added “study staff 
will” dispense 
additional doses of 
Furoscix and 
removed “Days 1, 2 
and 3. 
Updated dose 
dispensing on Day 0 
does not include doses 
for Days 1, 2, and 3. 
Subject returns to clinic 

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on Day 1 for dose 
evaluation.  
Amendment 1 
04 Nov 2020 
Section 6.2.3 p.30,  
Section 6.2.4 p.31,  
Section 6.2.5 p.31,  
Section 6.2.6 p.32,  
Section 6.2.7 p.32,  
Section 6.2.8 p. 33,  
Section 6.2.9 p. 34,  
Section 6.2.10 p. 34,  
Section 6.2.11 p. 35,  
Section 7 p. 38, 
Section 8.6 p. 45, 
Section 11 p. 52.  
Removed “treatment 
emergent” from 
treatment emergent 
adverse events. 
Removed to capture all 
adverse events. 
Amendment 1 
04 Nov 2020 
Section 6.2.23 p.37. 
Added “(Furoscix 
treatment group)” 
Added to specify 
Subject Diary 
instructions.  
Amendment 1 
04 Nov 2020 
Section 7 p. 38. 
Removed “Only 
treatment-emergent 
AEs and SAEs 
(occurring after the 
first placement of 
the product and/or 
dose of study drug 
through the follow-
up period) will be 
recorded in this 
study” and “after 
placement of the 
product and 
administration of 
study drug”. 
Removed to capture all 
adverse events 
continuously through 
the study. 
Amendment 1 
04 Nov 2020 
Section 8.6 Safety 
Analyses p. 45. 
Removed “A 
treatment emergent 
adverse event is an 
event that began or 
worsened in severity 
after start of study 
treatment”. 
Removed treatment 
emergent adverse 
events to capture all 
adverse events. 
Amendment 1 
04 Nov 2020 
Section 11.6 
Appendix 6: 
Dyspnea Status-7-
Point Likert Scale 
11.7, p. 59 
Appendix 7: 
Instructions for study 
staff administering 
Dyspnea Status 
Questionnaires (5-
Point and 7-Point 
Likert Scale) p. 60. 
Reworded 
“breathing just 
before study drug 
was started” to 
“breathing just 
before starting in the 
study” from Dyspnea 
Status - 7-Point 
Likert Scale. 
 
Added “indicate” and 
removed “check” 
Reworded instruction 
for Dyspnea Status - 7-
Point Likert Scale to be 
used for both study 
groups. 
 
Updated to clarify 
instructions for study 
staff for Dyspnea 
Questionnaires.  

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and “drug” from 
instructions. 
Amendment 2 
08 Dec 2020 
Section 6.2.1 p.29, 
Section 6.2.7 p.32, 
Section 6.2.9 p.34, 
Section 6.2.10 p. 34,  
Section 6.2.12 p. 
35., Appendix 1: 
Time and Events 
Schedule p. 52. 
Modified “Central” to 
“Centralized” lab. 
Added to clarify using a 
centralized lab for NT-
proBNP analysis. 
Amendment 2 
08 Dec 2020 
Section 6.2.1 p. 29 
Added to Screening 
(Day 0) “Assess for 
adverse events” and 
removed “prior to 
dosing". 
Administrative change 
to align Time and 
Events Schedule to 
assess AEs and record 
medications taken 
within 48 hours. 
Amendment 3  
10 Feb 2021 
Synopsis, Study 
Assessments and 
Procedures, p. 12,  
Section 3.2, p. 23, 
Section 5.5, p. 27, 
Section 6.2, p. 29, 
Section 6.2.2, p. 30 
Removed “Ideally, 
one dose would be 
prepared by the 
study Subject under 
the supervision of 
the study staff. The 
Subject may opt to 
apply the device 
before leaving the 
clinic but press the 
start button when 
they arrive home. 
The infusion must 
be started within 1 
hour of applying the 
Furoscix Infusor to 
the skin of the 
abdomen.”  
 
Removed “Some 
subjects may not 
require additional 
parental diuresis 
until the next day. In 
that case, the dose 
would not be 
prepared in the 
clinic.” (Section 3.2 
and 5.5). 
 
Specified that the 
initial dose of the 
study product may 
be administered in 
the clinic or at home 
on the day of 
enrollment. 
Removed device can 
be applied in the clinic 
and started at home to 
align with Instructions 
for Use and specified 
initial dose may be 
administered in the 
clinic or at home on day 
of enrollment. 

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Amendment 4 
30 Apr 2021 
Synopsis, Endpoint, 
p. 9, 
Statistical Analysis, 
p. 13, 
Section 3.2.1, p. 23, 
Section 3.2.2, p. 24, 
Section 6.1.1, p. 28, 
Section 6.1.2, p. 29, 
Section 8.4.1, p. 45, 
Section 8.4.2, p. 46    
Specified primary 
endpoint change in 
NT-proBNP from 
baseline at Day 7 
and added AEs. 
 
Added secondary 
endpoint of % Lung 
Fluid Measurement 
via Remote 
Dielectric Sensing 
(ReDS). 
Added clarity to NT-
proBNP primary 
endpoint and clarified 
AEs  primary endpoint. 
 
 
Added % Lung Fluid 
Measurement 
secondary endpoint.   
Amendment 4 
30 Apr 2021 
Synopsis, Study 
Design & Duration, 
p. 10, 
Section 6.2.1, p. 30, 
Section 6.2.3, p. 31, 
Section 6.2.5, p. 32, 
Section 6.2.7, p. 33, 
Section 6.2.9, p. 35, 
Section 6.2.10, p. 35 
Section 6.2.18,  
p. 38 
Time and Events 
Schedule, p. 53 
Added % Lung Fluid 
Measurement via 
Remote Dielectric 
Sensing (ReDS) 
assessment and 
added ReDS device 
and measurement 
description. 
Added ReDS 
measurement to clinic 
visits for secondary 
endpoint and provided 
device description. 
Amendment 4 
30 Apr 2021 
Synopsis, Study 
Design & Duration, 
p. 10, Study 
Assessments and 
Procedures, p. 13, 
Section 6.2.2 – 
6.2.11, p. 31 – 36, 
Section 6.2.2.4, 
p. 39, 
Time and Events 
Schedule, p. 54 
Added to record any 
observed device 
issues and updated 
Subject Diary 
description with 
device issue 
instruction and 
definition. 
Updated to capture 
observed device issues 
during clinic and phone 
visits and clarify a 
device issue. 
Amendment 4 
30 Apr 2021 
Synopsis, Study 
Design & Duration, 
p. 10, Number of 
Subjects, p. 11, 
Section 3.1, p. 20 
Increased number of 
subjects from 50 to 
51. 
Increased subject 
number to preserve 2:1 
ratio for randomization. 
Amendment 4 
30 Apr 2021 
Synopsis, Statistical 
Analysis, p. 13 
Section 8.1 – 8.3,  
p. 44 – 45, 
Section 8.4.1, p. 45, 
Section 8.4.2, p. 46 
Updated statistical 
analysis description. 
Updated to provide 
general description of 
statistical analysis 
noting details SAP.  
Amendment 4 
30 Apr 2021 
Abbreviations,  
p. 17 
Added abbreviations 
for AESI, ITT, MITT, 
PP, ReDS, SAP. 
Updated to include new 
abbreviations. 
Amendment 4 
30 Apr 2021 
Section 7.2. p. 41, 
Section 7.3. p. 41 
Removed Definition 
of Adverse Reaction 
and Suspected 
Adverse Reaction. 
All AEs will be collected 
and assessed if IP 
caused the adverse 
event. 

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Amendment 4 
30 Apr 2021 
Section 7.3. p. 41, 
Section 8.6. p. 46 
Added Adverse 
Events of Special 
Interest definition 
and analysis. 
Clarified Adverse 
Events of Special 
Interest and included in 
safety analysis. 
Amendment 5 
09 Dec 2021 
Synopsis, Study 
Design & Duration, 
p. 11, Study 
Assessments and 
Procedures, p. 14, 
Section 3.1, p. 21, 
Section 6.2. p. 30, 
Section 6.2.5, p. 33, 
Section 6.2.12, p. 37 
Time and Events 
Schedule, p. 54-55 
Added to Day 3 
clinic visit NT-
proBNP assessment 
and specified when 
NT-proBNP 
conducted. 
Updated to explore 
change in NT-proBNP 
from baseline at Day 3 
as well as Day 7 and 
clarify NT-proBNP 
assessments. 
Amendment 5 
09 Dec 2021 
Synopsis, Study 
Design & Duration, 
p. 11, Number of 
Subjects, p. 12, 
Section 3.1, p. 21 
Removed “Up to 51” 
and “evaluable” 
description for 
number of study 
subjects. 
Updated to clarify 51 
subjects will be 
included in the study. 
Amendment 5 
09 Dec 2021 
Synopsis, Subject 
Population, p. 12-13, 
Section 3.1, p. 21, 
Section 4.1, p. 25 
Removed “80” years 
from age limit and 
replaced with “18 
years or older”. 
Updated to remove the 
upper age limit.  
Amendment 5 
09 Dec 2021 
Synopsis, Statistical 
Analysis, p.14-15, 
Section 8.2, p. 46, 
Section 8.4.2, p. 47 
Identified 
populations for 
primary endpoints. 
Added “who 
received at least 1 
dose of the 
Investigational 
Product” to the 
definition of the 
Safety population. 
Removed the MITT 
(Modified Intent to 
Treat population). 
Modified the Per-
Protocol population 
definition to specify 
received “at least 
one dose” of the 
Investigational 
Product, “completed 
the Day 30 clinic 
visit assessments 
AND have a Day 7 
NT-proBNP value 
available for 
analysis”. 
Updated to align 
populations for analysis 
with the statistical 
analysis plan. 
 
 

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PROTOCOL APPROVAL PAGE 
 
Study Title: 
A Multicenter, Randomized, Open Label, Controlled Study 
Evaluating the Effectiveness and Safety of Furoscix On-Body 
Infusor vs Continued Medical Therapy for Worsening Heart 
Failure 
Protocol Number: 
scP-01-008 
Original Protocol 
Date of Issue: 
25 June 2020 
Amendment 1 Date: 
04 November 2020 
Amendment 2 Date: 
08 December 2020 
Amendment 3 Date: 
10 February 2021 
Amendment 4 Date: 
30 April 2021 
Amendment 5 Date: 
09 December 2021 
Sponsor Name and 
Address: 
 
scPharmaceuticals, Inc. 
2400 District Avenue, Suite 310 
Burlington, MA 01803 
 
I, the undersigned, have read and approve this protocol and agree on its content. It is 
confirmed that the information and guidance given in this protocol complies with scientific 
principles, the guidelines of Good Clinical Practices, the Declaration of Helsinki in the latest 
relevant version, and the applicable legal and regulatory requirements. 
 
Approval Section 
 
Name/Title 
Signature / Date 
Reviewed and 
Approved by: 
John Mohr, Pharm D 
SVP, Clinical 
Development and 
Medical Affairs 
Approvals obtained through MasterControl 
Reviewed and 
Approved by: 
Barbara Cornelius 
Associate Director, 
Clinical Operations 
Approvals obtained through MasterControl 
Reviewed and 
Approved by: 
Lucy Johnston 
VP, Program 
Management and  
Regulatory Affairs 
Approvals obtained through MasterControl 
Reviewed and 
Approved by: 
Michelle Whipple 
VP, Quality 
Approvals obtained through MasterControl 

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INVESTIGATOR PROTOCOL AGREEMENT 
Protocol Title: 
A Multicenter, Randomized, Open Label, Controlled Study 
Evaluating the Effectiveness and Safety of Furoscix On-Body 
Infusor vs Continued Medical Therapy for Worsening Heart Failure 
Protocol Number: 
scP-01-008 
Amendment 5 
 
By my signature, I  
• 
agree to conduct the study in accordance with the relevant, current protocol(s) and 
will only make changes in a protocol after notifying the Sponsor, except when 
necessary to protect the safety, rights, or welfare of Subjects.  
• 
agree to personally conduct or supervise the described investigation(s).  
• 
agree to inform any patients, or any persons used as controls, that the study 
product is being used for investigational purposes and I will ensure that the 
requirements relating to obtaining informed consent in 21 CFR Part 50 and 
institutional review board (IRB) review and approval in 21 CFR Part 56 are met.  
• 
agree to report to the Sponsor adverse experiences that occur during the 
investigation(s) in accordance with 21 CFR 312.64. I have read and understand 
the information in the Investigator’s brochure, including the potential risks and side 
effects of the study product.  
• 
agree to ensure that all associates, colleagues, and employees assisting in the 
conduct of the study are informed about their obligations in meeting the above 
commitments.  
• 
agree to maintain adequate and accurate records in accordance with 21 CFR 
312.62 and to make those records available for inspection in accordance with 21 
CFR 312.68.  
• 
will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will 
be responsible for the initial and continuing review and approval of the clinical 
investigation. I also agree to promptly report to the IRB all changes in the research 
activity and all unanticipated problems involving risks to human subjects or others. 
Additionally, I will not make any changes in the research without consent from the 
Sponsor and will not institute those changes in the research protocol until after IRB 
approval, except where necessary to eliminate apparent immediate hazards to 
human subjects.  
• 
agree to comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements in 21 CFR Part 312. 
 
 
 
Investigator's Signature 
 
Date 
Print Name 
 
 

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SYNOPSIS 
SHORT TITLE 
AT HOME-HF Pilot  
PROTOCOL TITLE 
A Multicenter, Randomized, Open Label, Controlled Study Evaluating the 
Effectiveness and Safety of Furoscix On-Body Infusor vs Continued Medical 
Therapy for Worsening Heart Failure 
PROTOCOL 
NUMBER 
scP-01-008 
SPONSOR 
scPharmaceuticals, Inc. 
INVESTIGATIONAL 
PRODUCT 
Furosemide Injection, 80 mg per 10 mL for subcutaneous administration via 
the Infusor (Furoscix On-body Infusor (hereinafter referred to as Furoscix 
Infusor))  
STUDY OBJECTIVES Primary Objective:  
• 
Provide pilot data on effectiveness and safety to inform a pivotal trial 
Secondary Objectives:  
• 
Inform population enrichment strategies 
• 
Refine pivotal trial endpoints and analytical methods 
• 
Identify operational challenges of study design 
• 
Assess patient adherence, competence, and experience  
• 
Familiarize staff and patients with device application and use 
ENDPOINTS 
Primary Endpoints:  
• 
Improvement in a composite/combined morbidity/mortality endpoint 
at 30 days using the Finkelstein Schoenfeld method.  
o 
Cardiovascular (CV) death 
o 
Heart Failure (HF) hospitalization 
o 
Urgent 
Emergency 
Department 
(ED)/Clinic 
visit 
for 
worsening heart failure (defined as Intravenous (IV) 
diuretics, augmentation of or new administration of 
metolazone) 
o 
Change in NT-proBNP from baseline at Day 7 
• 
Incidence of Adverse Events, Adverse Events of Special Interest, 
and Serious Adverse Events 
Secondary Endpoints (through 30 days): 
• 
Days alive and HF event free days 
• 
Global Visual Analog Scale 
• 
Composite Congestion Score (CCS) 
• 
5-point Current Dyspnea Score  
• 
7-point Dyspnea Score  
• 
Health-related quality of life (Kansas City Cardiomyopathy 
Questionnaire (KCCQ-12)) 
• 
Renal Function and Electrolytes 
• 
Weight   
• 
Exercise tolerance (Six Minute Walking Test (6MWT))  
• 
% Lung Fluid Measurement via Remote Dielectric Sensing (ReDS) 

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STUDY DURATION 
9 months 
PARTICIPANT 
DURATION 
30 days 
STUDY DESIGN & 
DURATION 
Study Design: 
This is a multicenter, randomized, open label, controlled study evaluating 
the effectiveness, and safety of the Furoscix Infusor vs continued medical 
therapy in patients with chronic heart failure and fluid overload requiring 
augmentation in diuretic therapy outside of acute care setting. Subjects will 
be randomly assigned (2:1) to receive Furoscix vs continued medical 
therapy. Within a single 24-hour period, the 80 mg dose can be repeated at 
the discretion of the investigator > 2 hours after the completion of the first 
dose. Subjects should be transitioned back to their oral maintenance 
diuretic regimen when clinically indicated at the discretion of the 
investigator. After Subjects have been transitioned to their oral maintenance 
diuretic regimen, additional doses of Furoscix can be prescribed during the 
30-day study period as needed based on the presence of congestion 
symptoms (e.g. dyspnea, edema, and/or excess weight gain) as determined 
by the investigator. No more than 7 doses of Furoscix is permitted during 
the 30-day study period. Additional doses beyond 7 requires approval by 
the medical monitor. Over the initial 7 days, all subjects will receive daily 
clinic or phone follow-up by the study staff. Decision of treatment with 
Furoscix in the intervention arm as well as changes in oral diuretic dosing 
in the control arm will be determined by the treating physician in 
coordination with the study nurse. Safety labs will be done on Days 1, 3, 7 
and 30. 
 
Methodology: 
Each Subject will complete Screening, Treatment, and Follow-Up Phases 
on an outpatient basis. During the Screening Phase, all Subjects who sign 
the informed consent form and satisfy the inclusion/exclusion criteria will be 
enrolled into the trial. Drug administration will start on the day of enrollment 
(same day as screening after all eligibility criteria have been confirmed) 
after randomization. NT-proBNP will be sent to centralized laboratory for 
subjects who qualify to participate. 
 
The Treatment Phase comprises a pre-programmed bi-phasic 5-hour drug 
administration of Furoscix (80 mg/10 mL) via the On-body Infusor. Subjects 
and/or their caregivers will be trained on device preparation, placement and 
removal in accordance with product instructions of use (IFU). Subjects will 
return to the clinic on Days 1, 3 and 7 for assessments including limited 
physical exam (including NYHA Class), CCS, 5-point Current Dyspnea 
Score, 7-point Dyspnea Score, vital signs, laboratory analyses, NT-proBNP 
(Day 3 and 7), adverse events, Visual Analog Scale (VAS), % Lung Fluid 
Measurement (ReDS), 6MWT (Day 1 and 7) and the KCCQ-12 (Day 7) and 
review Subject Diary including recorded device issues. On Days 2, 4, 5, 6 
and 17 subjects will receive a phone call from the site staff to assess 
Subject’s weight and vital signs that were obtained using the study 
equipment, 5-point Current Dyspnea Score, 7-point Dyspnea Score, VAS, 

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and report any adverse events and device issues. After Subjects have been 
transitioned to their oral maintenance diuretic regimen, additional doses of 
Furoscix for the treatment group or oral diuretics for the treatment as usual 
control group can be prescribed during the 30-day study period as needed 
based on the presence of congestion symptoms (e.g. dyspnea, edema, 
and/or excess weight gain) as determined by the investigator. If diuretic 
modifications are made after Subjects’ are transitioned to their oral 
maintenance diuretic regimen, the Subjects’ follow-up assessments and 
timing of those assessments will be based on the investigator’s clinical 
judgement. Unscheduled clinic and phone visits can be conducted as 
needed. All follow-up assessments done by phone or in-clinic will be 
documented. 
 
The Follow-Up Phase will include a visit to the clinic on Day 30 + 5 days 
where effectiveness and safety assessments will be performed including 
limited physical exam (including NYHA Class), CCS, 5-point Current 
Dyspnea Score, 7-point Dyspnea Score, vital signs, laboratory analyses, 
NT-proBNP, KCCQ-12, VAS, 6MWT, % Lung Fluid Measurement (ReDS), 
adverse events and review Subject Diary including recorded device issues. 
STUDY 
TREATMENTS 
Study Drug: Furoscix, (Furosemide Injection), 80 mg/10 mL is a 
proprietary furosemide formulation that is buffered to a neutral pH to 
enable subcutaneous administration and contained in a prefilled Crystal 
Zenith® (CZ) cartridge.  
 
Study Device: The Infusor is a compact, ethylene oxide (EtO) sterilized, 
single-use, electro-mechanical (battery powered, micro-processor 
controlled), on-body subcutaneous delivery system based on the 
SmartDose® Gen II 10 mL (West Pharmaceutical Services). 
 
The Furoscix Infusor is an investigational drug-device combination 
product. The Infusor is applied to the abdomen via a medical grade 
adhesive and delivers a subcutaneous infusion of Furoscix through a pre-
programmed, biphasic delivery profile with 30 mg (3.75 mL) administered 
over the first hour, followed by 12.5 mg (1.56 mL) per hour for the 
subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).    
 
NUMBER OF 
SUBJECTS 
Fifty-one (51) subjects will be included and randomly assigned (2:1) to 
receive Furoscix or continued medical therapy in the home setting with 30 
days of follow-up.  
NUMBER OF SITES 
This is a Multicenter, Randomized, Open Label, Controlled Study to be 
conducted at up to 20 sites. 
PARTICIPATING 
COUNTRIES 
US 
SUBJECT 
POPULATION 
 
 
Patients 18 years or older with chronic heart failure, NYHA Class II-IV 
symptoms, evidence of fluid overload requiring additional diuresis as 
assessed by the investigator, with either reduced or preserved LVEF, who 
are on background therapy including oral furosemide equivalent dose  

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between 40 and 160 mg of loop diuretic daily, inclusive or equivalent (20-
80 mg per day of torsemide or 1-4 mg per day of bumetanide). 
Subjects may be enrolled in the study only if all the inclusion criteria and 
none of the exclusion criteria are met. 
Inclusion Criteria: 
Subjects are eligible for inclusion only if all the following criteria are met: 
1. 
Age 18 years or older. 
2. 
Diagnosis of symptomatic chronic heart failure (NYHA Class II-
IV) with background loop diuretic therapy for at least 4 weeks. 
3. 
Need for augmented diuresis outside of the acute care 
setting as determined by the investigator. 
4. 
On background therapy including daily total furosemide equivalent 
dose (40-160 mg) of loop diuretic or equivalent. 
5. 
The subject must have signs of volume expansion, defined as 
two or more of the following six signs: 
a) 
jugular venous distention 
b) 
edema (≥ 1+) 
c) 
ascites 
d) 
pulmonary congestion on chest x-ray 
e) 
pulmonary rales 
f) 
NT-proBNP ≥1000 pg/ml (1400 for patients in atrial fibrillation) 
or, for patients not on Entresto, BNP ≥200 (400 for patients in 
atrial fibrillation) 
6. 
Increase over the preceding 30 days in at least one of the 
following symptoms characteristic of worsening heart failure: 
a) 
dyspnea 
b) 
fatigue 
c) 
exercise intolerance 
7. 
Adequate environment for at home administration of Furoscix by 
patient or caregiver. 
 
Exclusion Criteria: 
A Subject is not eligible for inclusion if any of the following criteria apply: 
1. Suspected high risk clinical instability with outpatient treatment. 
2. Presence of a complicating condition, other than heart failure likely 
to require hospitalization in next 30 days. 
3. Pregnant women or women of childbearing age who are not willing 
to use an adequate form of contraception. 
4. Known allergy to the active and inactive ingredients of the 
study medication or device adhesive. 
5. On experimental medication or currently participating in 
another interventional research study. 
6. eGFR < 20 
7. Serum potassium at baseline > 5.4 or < 3.6 
8. Concomitant infection 
9. Heart rate > 110 
10. Received IV furosemide or IV bumetanide within last 24 hours 

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STUDY 
ASSESSMENTS AND 
PROCEDURES 
The following study assessments and procedures will be performed: 
Patients will be assessed in the clinic or medical practice by the investigator 
and/or study staff for NYHA Class II-IV heart failure and signs and 
symptoms associated with volume overload. If it is determined by the 
investigator that the patient requires augmented diuresis outside of the 
acute care setting and meets all eligibility criteria, he/she may be consented 
and enrolled into the study. NT-proBNP will be sent to centralized 
laboratory. For Subjects within the 2 randomization groups, continued 
medical therapy or Furoscix therapy will be managed by the investigator. 
Subjects randomized to Furoscix will be instructed on the use of the Infusor 
by the investigator and/or study staff in accordance with the Instructions for 
Use. The initial dose of the study product may be administered in the clinic 
or at home on the day of enrollment. Additional doses will be provided to 
the Subject for self-administration or administration by a caregiver in the 
home setting as directed by the investigator or study staff. All subjects will 
receive daily follow-up for the initial 7 days. Subjects will receive home 
telephone calls from heart failure (HF) nurse, or designee, on Days 2, 4, 5, 
6 and 17 and clinic visits with laboratory analyses on Days 1, 3, 7 and 30 
and NT-proBNP Days 3, 7 and 30. To the extent possible, the same 
caregiver will be used for all visits. Administration by the Subject and/or 
caregiver will be assessed by HF nurse, or designee, telephone interviews. 
Subjects will record the start of each administered dose, presence of 
congestion symptoms and their assessment of the ease of utilization with 
the Furoscix Infusor including device issues in a diary.  
After Subjects have been transitioned to their oral maintenance diuretic 
regimen, additional doses of Furoscix can be prescribed during the 30-day 
study period as needed based on the presence congestion symptoms (e.g. 
dyspnea, edema, and/or excess weight gain) as determined by the 
investigator. No more than 7 doses of Furoscix is permitted during the 30-
day study period. Additional doses beyond 7 requires approval by the 
medical monitor. If modifications are made to the diuretic regimen after 
Subjects’ are transitioned to their oral maintenance diuretic regimen, 
including additional doses of Furoscix for the treatment group or oral 
diuretics for the treatment as usual control group, the Subjects’ follow-up 
assessments and timing of those assessments will be based on the 
investigator’s clinical judgement. Unscheduled clinic and phone visits can 
be conducted as needed. 
The study period will be 30 + 5 days after enrollment. Survival and 
unplanned heart failure events will be assessed for 30 + 5 days after 
enrollment. 
STATISTICAL 
ANALYSIS 
Baseline variables will be assessed by treatment group using descriptive 
statistics. The primary endpoints will be measured using the Finkelstein-
Schoenfeld Method.  
 
Primary Endpoints 
The primary analysis is to compare the components of the primary 
composite endpoint hierarchically using the Finkelstein-Schoenfeld 
Method. The primary endpoints will be compared between treatment groups 

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on the Intent-to-Treat (ITT) population and Per-Protocol populations as 
described in the SAP. Each patient is compared to all other patients with 
respect to each of the following endpoints at 30 days:  
 
 
CV death 
 
HF hospitalization 
 
Urgent ED/Clinic visit for worsening heart failure (defined as IV 
diuretics, augmentation of or new administration of metolazone) 
 
Change in NT-proBNP from baseline at Day 7 
 
Incidence of Adverse Events, Adverse Events of Special Interest, and 
Serious Adverse Events will be described in each group. 
 
Secondary Endpoints 
Statistical comparison of treatment vs. control groups will be conducted for 
each secondary endpoint at a two-sided 0.05 level of significance.  
The following secondary endpoints will be compared between treatment 
groups on the Intent-to-Treat (ITT) population and Per-Protocol 
populations as described in the SAP: 
 
Days alive and heart failure event-free (hospitalization for heart 
failure or ED visits for heart failure) over 30 days.  
 
Changes from baseline in patient global assessment via visual 
analog scale (VAS) across follow-up timepoints.  
 
Changes from baseline in composite congestion score (CCS) 
across follow-up timepoints.  
 
Changes from baseline in 5-point Current Dyspnea Score across 
follow-up timepoints.  
 
7-point Dyspnea Score across follow-up time points.  
 
Changes from baseline in health-related quality of life measured by 
the KCCQ-12 Short Form Summary Score across follow-up 
timepoints.  
 
Changes from baseline in serum creatinine across follow-up 
timepoints.  
 
Change from baseline in ambulatory body weight across follow-up 
timepoints.  
 
Changes from baseline in the Six-Minute Walk Test (6MWT) across 
follow-up timepoints.  
 
Changes from baseline in the ReDS Lung Fluid Measurement 
across follow-up time points. 

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TABLE OF CONTENTS 
PRINCIPAL INVESTIGATORS .................................................................................................... 2 
SPONSOR CONTACT INFORMATION ...................................................................................... 2 
PROTOCOL APPROVAL PAGE ................................................................................................. 8 
INVESTIGATOR PROTOCOL AGREEMENT ............................................................................ 9 
SYNOPSIS .................................................................................................................................... 10 
ABBREVIATIONS ........................................................................................................................ 18 
1. 
INTRODUCTION................................................................................................................... 19 
1.1. Rationale for the Current Study ......................................................................... 20 
1.2. Risk: Benefit Evaluation ..................................................................................... 20 
2. 
STUDY OBJECTIVES .......................................................................................................... 21 
3. 
INVESTIGATIONAL PLAN.................................................................................................. 21 
3.1. Overall Study Design and Plan ......................................................................... 21 
3.2. Furoscix Infusor .................................................................................................. 22 
4. 
SELECTION OF STUDY POPULATION ........................................................................... 25 
4.1. Inclusion Criteria ................................................................................................. 25 
4.2. Exclusion Criteria ................................................................................................ 25 
4.3. Removal of Subjects from Therapy/Premature Discontinuation .................... 26 
5. 
TREATMENTS ...................................................................................................................... 26 
5.1. Treatments Administered ................................................................................... 26 
5.2. Identity of Investigational Product(s) ................................................................. 26 
5.3. Method of Assigning Subjects to Treatment Groups ....................................... 27 
5.4. Selection of Doses in the Study ........................................................................ 27 
5.5. Selection and Timing of Dose for Each Subject .............................................. 28 
5.6. Procedures for Blinding ...................................................................................... 28 
5.7. Prior and Concomitant Therapy ........................................................................ 28 
5.8. Prohibited Medications ....................................................................................... 28 
5.9. Other Restrictions ............................................................................................... 28 
5.10. Study Stopping Criteria .................................................................................... 29 
5.11. Treatment Compliance ..................................................................................... 29 
5.12. Study Drug-Device Combination Accountability ............................................ 29 
6. 
STUDY PROCEDURES ....................................................................................................... 29 
6.1. Study Measurements and Assessments .......................................................... 29 
6.2. Study Phases and Procedures .......................................................................... 30 
7. 
ADVERSE EVENTS ............................................................................................................. 40 
7.1. Definition of an Adverse Event (AE) ................................................................. 41 
7.2. Definition of a Serious Adverse Event (SAE) ................................................... 42 
7.3. Definition of an Adverse Event of Special Interest (AESI) .............................. 42 

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7.4. Severity of AEs/SAEs ......................................................................................... 43 
7.5. Outcome of AE/SAEs ......................................................................................... 43 
7.6. Assessment of Relatedness to Study Product ................................................. 43 
7.7. Method, Frequency, and Time Period for Detecting Adverse Events and 
Serious Adverse Events ..................................................................................... 44 
8. 
STATISTICS.......................................................................................................................... 45 
8.1. General Statistical Issues .................................................................................. 45 
8.2. Analysis Populations .......................................................................................... 46 
8.3. Baseline Characteristics and Subject Disposition ........................................... 46 
8.4. Effectiveness Analyses ...................................................................................... 46 
8.5. Interim Analysis ................................................................................................... 47 
8.6. Safety Analyses .................................................................................................. 47 
8.7. Subgroup Analysis .............................................................................................. 47 
9. 
RESPONSIBILITIES ............................................................................................................ 48 
9.1. Investigator Responsibilities .............................................................................. 48 
9.2. Sponsor Responsibilities .................................................................................... 51 
9.3. Joint Investigator/Sponsor Responsibilities ...................................................... 51 
10. REFERENCES ...................................................................................................................... 52 
11. APPENDICES ....................................................................................................................... 54 
11.1. Appendix 1. Time and Events Schedule ........................................................ 54 
11.2. Appendix 2. Patient Global Assessment Visual Analog Scale (EQ-VAS)... 56 
11.3. Appendix 3. Kansas City Cardiomyopathy Questionnaire – 12 ................... 57 
11.4. Appendix 4: Composite Congestion Score .................................................... 59 
11.5. Appendix 5: Current Dyspnea Status - 5-Point Likert Scale ........................ 60 
11.6. Appendix 6: Dyspnea Status  -  7-Point Likert Scale .................................... 61 
11.7 Appendix 7: Instructions for study staff administering Current Dyspnea 
Status Questionnaire (5-Point Likert Scale) and Dyspnea Status 
 
Questionnaire (7-Point Likert Scale….………………………………….…………..62 
 
 
 

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ABBREVIATIONS 
 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest  
βhCG 
Beta-human Chorionic Gonadotropin 
BMI 
Body Mass Index 
Bpm 
Beats per minute 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CCS 
Composite Congestion Score 
CV 
Cardiovascular 
ED 
Emergency Department 
FDA 
Food and Drug Administration  
GCP 
Good Clinical Practice 
HF 
Heart Failure 
ICH 
International Conference on Harmonization 
IFU 
Instructions for Use 
IND 
Investigational New Drug 
IP 
Investigational Product 
IRB/EC 
Institutional Review Board/Ethics Committee 
ITT  
Intent-to-Treat population  
IV 
Intravenous 
KCCQ 
Kansas City Cardiomyopathy Questionnaire 
mmHg 
millimeters of mercury 
NYHA 
New York Heart Association 
PP 
Per-Protocol population 
ReDS 
Remote Dielectric Sensing 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
6MWT 
Six Minute Walking Test 

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1.   
INTRODUCTION 
Heart Failure affects 6.5 million adults in the United States, a figure that is expected to grow 
to 8 million by 2030. Heart Failure is one of the most common causes of hospital admissions 
in patients over 65 with at least 1-2 million hospitalizations in the United States annually 
(Benjamin et al. 2018; Agarwal et al. 2016). Increasing signs and symptoms of congestion 
and fluid overload are the main reasons heart failure patients seek medical care and are 
hospitalized (Mullens et al., 2019). Symptoms of congestion generally worsen over several 
days or weeks providing a window of opportunity to intervene to avoid a potential unnecessary 
hospitalization (Schiff et al. 2003; Greene et al. 2018).   
It is known that during periods of worsening congestion in heart failure, the bioavailability of 
oral furosemide is reduced and becomes highly variable (Vasko et al. 1985; Ellison et al. 
2017). To overcome the limitation of oral furosemide in this setting, two strategies are typically 
employed. First, the oral furosemide dose is typically doubled, or additional oral diuretics 
(thiazide diuretics) are added to overcome the blunted pharmacological response to these 
agents. When this fails, clinicians often rely on giving IV diuretics, either in the hospital, an 
outpatient heart failure clinic or an infusion center, if available (Greene et al. 2018; Mullens et 
al. 2019). Hospitalization solely for the purpose of administration of intravenous furosemide is 
not a cost-effective strategy, is inconvenient for patients and their family, and places patients 
at risk for increased nosocomial infections and iatrogenic complications.    
After hospitalization for heart failure, 25-30% of patients are readmitted within 30 days. It 
has been estimated that up to 50% of patients hospitalized for an episode of acute 
decompensated heart failure are discharged on oral diuretics with persistent signs and 
symptoms of congestion (Costanzo et al. 2007; Fonarow et al. 2005; Neuenschwander et al. 
2007). The presence of congestion at discharge has been associated with an increased risk 
of 30-day all-cause mortality and rehospitalization for heart failure (Ambrosy et al. 2013).  
Patients hospitalized for heart failure should have a post discharge follow up visit within 14 
days of hospital discharge (Yancy et al. 2013).       
Alternative treatment paradigms that shift the management of congestion in patients with heart 
failure to outside of the acute care setting and improve congestion management post hospital 
discharge are urgently needed. If such options were available, another potential benefit would 
be early effective treatment in the outpatient setting to avoid early decompensation worsening 
into the full-blown syndrome of acute decompensated heart failure and potentially reduce 30-
day readmission rates.  
Furoscix is a novel formulation of furosemide buffered to a neutral pH to enable subcutaneous 
administration. It is intended to be administered subcutaneously via an On-Body Infusor, a 
compact, 
wearable, 
pre-programmed 
subcutaneous 
drug 
delivery 
system. 
The 
pharmacokinetics of Furoscix 80 mg administered subcutaneously over 5 hours in a biphasic 
regimen (30 mg in the first hour, followed by 12.5 mg/hour for the subsequent 4 hours) 
demonstrated comparable drug exposures to 2 doses of furosemide 40mg administered 
intravenously over 2 minutes 2 hours apart. In addition, the average 8- and 24-hour urine 
output and natriuresis was comparable between IV furosemide and Furoscix (Sica et al. 2018).  

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1.1.   Rationale for the Current Study 
The purpose of this study is to evaluate the effectiveness and safety of the Furoscix Infusor 
vs continued medical therapy in patients with chronic heart failure and fluid overload requiring 
augmentation in diuretic therapy outside of acute care setting. 
The study is being executed under IND 118919 following all regulations required for 
Investigational Drug products.  
1.2.   Risk: Benefit Evaluation 
1.2.1.   
Potential Benefits of Participating in the Study 
There are no potential benefits to the participants beyond their contribution to the 
development and testing of this product. 
1.2.2.   
Potential Risks of Participating in the Study 
Furosemide has been widely studied and used clinically for over 50 years. It is generally 
considered a safe and effective pharmaceutical product. Patients may experience marked 
diuresis following the placement and activation of this drug-device combination product.  
Access to bathroom facilities is of critical importance and patients should be instructed to have 
instant access to suitable facilities. Marked diuresis may be accompanied by a drop-in blood 
pressure including orthostatic hypotension and associated signs and symptoms.  
1.2.3.   
Risk Management 
Subjects will be trained by the study staff on appropriate use of the Furoscix Infusor and will 
receive specific instructions and study materials created for the study (based on the Furoscix 
Infusor Instructions for Use) that include information regarding what to do in case of certain 
events during the drug delivery period. 
 
Subjects should be transitioned back to their oral maintenance diuretic regimen when clinically 
indicated at the discretion of the investigator. After Subjects have been transitioned to their 
oral maintenance diuretic regimen, additional doses of Furoscix may be prescribed during the 
30-day study period as needed based on the presence of symptoms of congestion (dyspnea, 
edema, and/or excess weight gain) as determined by the investigator. No more than 7 doses 
of Furoscix is permitted during the 30-day study period. Additional doses beyond 7 requires 
approval by the medical monitor. If modifications are made diuretic regimen after Subjects’ 
are transitioned to their oral maintenance diuretic regimen, including additional doses of 
Furoscix for the treatment group or oral diuretics for the treatment as usual control group, the 
Subjects’ follow-up assessments and timing of those assessments will be based on the 
investigator’s clinical judgement.   
 
Subjects will receive scheduled at-home telephone calls from a HF nurse, or designee, on 
Days 2, 4, 5, 6 and 17. Four planned in-clinic visits will be conducted: the first occurring on 
Day 1, the second on Day 3, the third occurring on Day 7 and the fourth occurring on Day 30 
± 5 days.  Unscheduled calls and clinic visits can be conducted as needed. The primary 
purpose of the calls will be to evaluate the clinical response to diuretic therapy and the need 
to adjust diuretic therapy. Clinic visits will include assessment of creatinine and electrolytes. 

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2.   
STUDY OBJECTIVES 
The objectives of this study are:  
Primary Objective: 
• 
To provide pilot data on the effectiveness and safety to inform a pivotal trial 
 
Secondary Objectives: 
• 
To inform population enrichment strategies 
• 
To refine pivotal trial endpoints and analytical methods 
• 
To identify operational challenges of study design 
• 
To assess patient adherence, competence, and experience  
• 
To familiarize staff and patients with device application and use 
3.   
INVESTIGATIONAL PLAN 
3.1.   Overall Study Design and Plan 
This study is a multicenter, randomized, open label, controlled study evaluating the 
effectiveness, and safety of the Furoscix Infusor vs continued medical therapy in patients with 
chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of 
acute care setting. The study will enroll 51 subjects 18 years or older with chronic heart failure, 
NYHA Class II-IV symptoms, evidence of fluid overload requiring additional diuresis as 
assessed by the investigator, with either reduced or preserved LVEF, who are on background 
therapy including oral furosemide equivalent dose between 40 and 160 mg of loop diuretic 
daily, inclusive or equivalent (20-80 mg per day of torsemide or 1-4 mg per day of 
bumetanide). The subjects will be randomly assigned (2:1) to receive Furoscix Infusor vs 
continued medical therapy.      
Each Subject will complete Screening, Treatment, and Follow-Up Phases on an outpatient 
basis. During the Screening Phase, all subjects who sign the informed consent form and 
satisfy the inclusion/exclusion criteria will be enrolled into the trial. Drug administration will 
start on the day of enrollment (same day as screening after all eligibility criteria have been 
satisfied) and subject has been randomized. NT-proBNP will be sent to centralized laboratory 
for subjects who qualify to participate. 
The Treatment Phase will start once screening procedures have been completed and 
eligibility is confirmed. Subjects and/or their caregivers will be trained on device preparation, 
placement and removal in accordance with product instructions of use (IFU). Furoscix will be 
administered daily via the Furoscix Infusor whereby 80 mg is administered subcutaneously 
over 5 hours in a biphasic regimen (30 mg in the first hour, followed 12.5 mg per hour for the 
subsequent 4 hours). Within a single 24-hour period, the 80 mg dose can be repeated at the 
discretion of the investigator > 2 hours after the completion of the first dose. The dosing 
frequency and duration of therapy will be determined by the investigator based on an 
estimated volume of diuresis desired to transition Subject back to their oral maintenance 
diuretic therapy. The decision of when to discontinue Furoscix and switch to oral diuretics will 
be based on clinical judgement. 
Subjects will be followed up at an in-clinic visit on Days 1, 3 and 7 and through a phone call 
from site staff on Days 2, 4, 5, 6 and 17 to assess for signs and/or symptoms of congestion.  

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After the Day 7 clinic visit, subjects will continue to utilize the provided equipment and weigh 
themselves and record their blood pressure and heart rate approximately the same time each 
morning. Additional doses of Furoscix can be prescribed as needed due to congestion 
symptoms (e.g. dyspnea, edema, and/or excess weight gain) as determined by the 
investigator. In addition to the scheduled phone and clinic visits, the investigator can utilize 
unscheduled clinic or phone visits for additional assessments at any time. No more than 7 
doses of Furoscix is permitted during the 30-day study period. Additional doses beyond 7 
requires approval by the medical monitor. If diuretic modifications are made after Subjects’ 
are transitioned to their oral maintenance diuretic regimen, including additional doses of 
Furoscix in the treatment group or oral diuretics for the treatment as usual control group, the 
Subjects’ follow-up assessments and timing of those assessments will be based on the 
investigator’s clinical judgement. Unscheduled clinic and phone visits can be conducted as 
needed. All follow-up assessments done by phone or in-clinic will be documented. 
For the Follow-Up Phase, Subjects will return to the clinic on Day 30 + 5 days (30-days post 
randomization) for a final follow-up visit where effectiveness and safety assessments will be 
performed. 
3.2.   Furoscix Infusor  
The Furoscix Infusor is a drug-device combination product consisting of Furoscix (Furosemide 
injection, 80 mg per 10 mL), a novel, pH neutral furosemide formulation optimized for 
subcutaneous administration and contained in a prefilled, Crystal Zenith (CZ) cartridge, and a 
proprietary wearable, pre-programmed on-body delivery system, the Infusor, based on the 
SmartDose Gen II 10 mL (West Pharmaceutical Services). 
 
The Infusor is a compact, ethylene oxide (EtO) sterilized, single-use, electro-mechanical 
(battery powered, micro-processor controlled), on-body delivery system that administers a 
fixed dose of drug product from a prefilled cartridge assembly into subcutaneous tissue of the 
abdomen. It is intended for use by patients, caregivers, or a health care professional (HCP) 
at home or in a clinic setting.  
 
The Furoscix Infusor is 117 mm x 62 mm x 30 mm (length x width x height) and weighs 
approximately 80 grams without the drug cartridge and 90 grams, with a filled drug cartridge 
inserted into the drug compartment. It has an integrated, adhesive patch which attaches the 
Infusor to the skin for dose administration. The device with adhesive is removed from the skin 
following completion of the dose and discarded.   
 
The system delivery parameters will be pre-programmed as part of the manufacturing process 
to deliver 80 mg (10 mL) furosemide over 5 hours using a biphasic delivery profile of 30 mg 
furosemide (3.75 mL) over the first hour and 12.5 mg furosemide (1.56 mL) per hour over the 
subsequent 4 hours. The device elements are shown in Figure 1. 

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Figure 1: Main components of Furoscix On-Body Infusor  
The Furoscix Infusor utilizes a primary container, which consists of the CZ cartridge (CZ barrel 
and elastomeric septum) and elastomeric piston. The primary container assembly is prefilled 
with the Furoscix as part of the fill-finish process.   
 
Following removal of the Furoscix Infusor from the packaging, the drug compartment of the 
device is opened by the user, which turns the device on, and a built-in self-test is performed 
to verify the needle/button position, correct software parameters, the device was not operated 
prior to the current activation and the motor and batteries are functional. 
 
The user inserts the prefilled Cartridge into the drug compartment, closes the compartment, 
removes the adhesive liner and attaches the loaded Furoscix Infusor to the skin of the 
abdomen. Pressing the activation button automatically inserts the small, 27-guage, 6 mm 
needle into the subcutaneous tissue and drug administration is initiated. The needle is 
protected within the device and can only be deployed when the prefilled Cartridge is in place, 
the cartridge compartment is closed, the device is adhered to the patient, the safety latch is 
closed, and the activation button has been pressed. Dose administration stops automatically 
upon completion of drug delivery or opening of the safety latch upon the removal of the device 
from the abdomen.   
 
The Furoscix Infusor is designed to administer the entire dose without user intervention. The 
dose volume and dose administration time cannot be changed by the user. Both visual and 
auditory notifications provide feedback on the progress of drug administration. In the event of 
a drug delivery error, visual and auditory notification will alert the user. Once drug 
administration is complete, accompanied by visual and auditory notifications, the user 
removes the system with the administration needle by carefully peeling the adhesive from the 
skin which automatically opens the safety latch to conceal and protect the administration 
needle. The empty Cartridge cannot be removed from the system after administration of the 

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drug product and the integrated Cartridge/Infusor are disposed of together. The device is 
battery-powered and enables removal of the battery by the user prior to disposal.  
 
The clinical study will include training the Subject and/or caregiver in the preparation, placement, 
activation and removal of the Furoscix Infusor based on the Furoscix Infusor Instructions for 
Use (IFU).  
 
Training for study staff on the device operation and placement following the IFU and subject 
specific instructions will be conducted during an Investigator Meeting(s) and/or at the Site 
Initiation(s).  
 
Subjects will be instructed on the use of the Furoscix Infusor by the investigator and/or study 
staff in accordance with the IFU and subject specific instructions. The initial dose of the study 
product may be administered in the clinic or at home on the day of enrollment. Additional 
doses will be provided to the subject for self-administration or administration by a caregiver in 
the home setting as directed by the investigator or study staff.  
 
Study Subjects will be provided with instructions based on the IFU of the product. These 
include to not shower, bathe, swim or do activities that may cause sweat while wearing the 
Furoscix Infusor because it contains parts that should not get wet. Participants will be informed 
that marked diuresis may ensue after activation and that they should have access to bathroom 
facilities for up to 8 hours after starting the infusion.  
 
If the Subject experiences leakage or pain during the infusion period, they are instructed to 
call the study team at the clinical site as designated on the informed consent form and subject 
specific instructions. If the infusion is interrupted for any reason (i.e. see visual and hear audio 
notifications) or the device becomes detached during the infusion period, subjects are 
instructed to call the study team at the clinical site. Following dosing and device removal, 
subjects should place the used Furoscix Infusor in the box and bring back to the clinic at their 
next scheduled study visit. Subjects will return all Furoscix Infusors by the Day 30 in-clinic 
visit. 
 
3.2.1.   
Primary Endpoints 
• 
Improvement in a composite/combined morbidity/mortality endpoint at 30 days using 
the Finkelstein Schoenfeld method.  
• 
CV death 
• 
HF hospitalization 
• 
Urgent ED/Clinic visit for worsening heart failure (defined as IV diuretics, 
augmentation of or new administration of metolazone) 
• 
Change in NT-proBNP from baseline at Day 7 
• 
Incidence of Adverse Events, Adverse Events of Special Interest, and Serious 
Adverse Events 
3.2.2.   
Secondary Endpoints (through 30 days) 
• 
Days alive and HF event free days 
• 
Global Visual Analog Scale 

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• 
Composite Congestion Score 
• 
5-point Current Dyspnea Score   
• 
7-point Dyspnea Score 
• 
Health-related quality of life (KCCQ-12) 
• 
Renal Function and Electrolytes 
• 
Weight  
• 
Exercise tolerance (6MWT) 
• 
% Lung Fluid Measurement via Remote Dielectric Sensing (ReDS) 
  
3.2.3.   
Adverse Events of Special Interest over 30 Days 
• 
Worsening kidney function, defined as increase of ≥ 0.5 mg/dl in serum creatinine 
• 
Hyperkalemia, defined as K > 5.5 mEq/L  
• 
Hypokalemia, defined as K < 3.5 mEq/L 
• 
Hypomagnesemia, defined as Mg < 1.5 mg/dL 
4.   
SELECTION OF STUDY POPULATION 
4.1.   Inclusion Criteria 
Female and male Subjects are eligible for inclusion only if all the following criteria are met: 
1. 
Age 18 years or older. 
2. 
Diagnosis of symptomatic chronic heart failure (NYHA Class II-IV) with background 
loop diuretic therapy for at least 4 weeks. 
3. 
Need for augmented diuresis outside of the acute care setting as determined 
by the investigator. 
4. 
On background therapy including daily total furosemide equivalent dose (40-160 mg) 
of loop diuretic or equivalent. 
5. 
The subject must have signs of volume expansion, defined as two or more of the 
following six signs: 
a) 
jugular venous distention 
b) 
edema (≥1+) 
c) 
ascites 
d) 
pulmonary congestion on chest x-ray 
e) 
pulmonary rales 
f) 
NT-proBNP ≥1000 pg/ml (1400 for patients in atrial fibrillation) or, for patients not 
on Entresto, BNP ≥200 (400 for patients in atrial fibrillation) 
6. 
Increase over the preceding 30 days in at least one of the following symptoms 
characteristic of worsening heart failure: 
a) 
dyspnea 
b) 
fatigue 
c) 
exercise intolerance 
7. 
Adequate environment for at home administration of Furoscix by patient or caregiver. 
4.2.   Exclusion Criteria 
A Subject is not eligible for inclusion if any of the following criteria apply:  
1. Suspected high risk clinical instability with outpatient treatment. 
2. Presence of a complicating condition, other than heart failure likely to require 

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hospitalization in next 30 days. 
3. Pregnant women or women of childbearing age who are not willing to use an adequate 
form of contraception. 
4. Known allergy to the active and inactive ingredients of the study medication or 
device adhesive. 
5. On experimental medication or currently participating in another interventional 
research study. 
6. eGFR < 20 
7. Serum potassium at baseline > 5.4 or < 3.6 
8. Concomitant infection 
9. Heart rate > 110 
10. Received IV furosemide or IV bumetanide within last 24 hours 
4.3.   Removal of Subjects from Therapy/Premature Discontinuation 
Subjects may voluntarily withdraw at any time, but once treatment has occurred, every attempt 
will be made to continue assessments to ensure the safety of the subject. A Subject will be 
discontinued from the study for the following medical or administrative reasons: 
• 
Subject wishes to withdraw consent 
• 
Safety reasons, e.g. AEs 
• 
Subject non-compliance with study procedures required by the protocol 
• 
Principal Investigator discretion 
The Investigator may discontinue individual Subjects from the study if anatomical or skin 
conditions prevent proper placement of the device.   
Subjects who withdraw or are withdrawn prior to study completion may be replaced. As far as 
possible, subjects who withdraw from the study after treatment, and before completion should 
be seen by the PI or delegate and undergo the assessments and procedures scheduled for 
the follow-up visit.  
5.   
TREATMENTS 
5.1.   Treatments Administered  
Study drug will be administered by the Subject or the Subject’s caregiver only in accordance 
with the procedures described in this protocol and in the Instructions for Use. 
5.2.   Identity of Investigational Product(s) 
Study Drug: Furoscix, (Furosemide Injection), 80 mg/10 mL is a proprietary furosemide 
formulation that is buffered to a neutral pH to enable subcutaneous administration and 
contained in a prefilled, Crystal Zenith (CZ) cartridge. 
 
Furoscix (Furosemide Injection), 10 mL buffered furosemide solution (8 mg/mL), is 
manufactured by Swissfilllon AG, Rottenstrasse 7, CH-3930 Visp, Switzerland under good 
manufacturing practice conditions. Contains Tris Hydrochloride and may contain Sodium 
Chloride Hydrochloric Acid for pH adjustment: pH 7.4 (range 7.0 to 7.8).  
 

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Study device: The Infusor is a compact, ethylene oxide (EtO) sterilized, single-use, electro-
mechanical (battery powered, micro-processor controlled), on-body subcutaneous delivery 
system based on the SmartDose Gen II 10 mL (West Pharmaceutical Services). 
 
The Furoscix Infusor is an investigational drug-device combination product. The Infusor is 
applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion 
of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) 
administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 
hours (Total dose is 80 mg (10 mL) over 5 hours). 
   
5.2.1.   
Labeling 
Study drug (Furosemide Injection (Furoscix)) and study device (On-Body Infusor) will bear 
labels that meet applicable laws for an investigational drug-device combination, which may 
include, but is not limited to, the following information: 
• 
Federal law statement 
• 
Batch number  
• 
Storage information 
Study specific instructions for the use and operation of the product will be available to the PI, 
study staff and subjects. These materials will be based on the Furoscix Infusor Instructions for 
Use of the study product as it exists at the time of the study.  
  
5.2.2.   
Storage and Handling 
Store study drug at 15° - 30°C, (59° - 86°F). Protect from Light.   
 
5.3.   Method of Assigning Subjects to Treatment Groups 
5.3.1.   
Treatment Assignment/Randomization 
Subjects will be randomly assigned (2:1) to receive the Furoscix Infusor or continued medical 
therapy.    
5.4.   Selection of Doses in the Study 
The dose of 80 mg is the fixed dose of Furoscix. This was selected based on clinical criteria 
and physician prescribing and is consistent with the approved labeling of furosemide injection, 
United States Pharmacopeia. The dosing frequency and duration of the initial therapy will be 
determined by the investigator based on an estimated volume of diuresis desired to transition 
Subject back to their oral maintenance diuretic therapy. The total duration in days and number 
of doses will be determined by the treating investigator based on an estimated volume of 
diuresis desired to transition Subject back to their oral maintenance diuretic therapy. 
 
After Subjects have been transitioned to their oral maintenance diuretic regimen, additional 
doses of Furoscix can be prescribed during the 30-day study period as needed based on the 
presence of symptoms of congestion (dyspnea, edema, and/or excess weight gain) as 
determined by the investigator. No more than 7 doses of Furoscix is permitted during the 30-
day study period. Additional doses beyond 7 requires approval by the medical monitor. 

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5.5.   Selection and Timing of Dose for Each Subject  
Furoscix will be administered daily via the Furoscix Infusor whereby 80 mg is administered 
subcutaneously over 5 hours in a biphasic regimen (30 mg in the first hour, followed 12.5 
mg/hour for the subsequent 4 hours). Within a single 24-hour period, the 80 mg dose can be 
repeated at the discretion of the investigator > 2 hours after the completion of the first dose. 
The dosing frequency and duration of the initial therapy will be determined by the investigator 
based on an estimated volume of diuresis desired to transition Subject back to their oral 
maintenance diuretic therapy. 
 
After Subjects have been transitioned to their oral maintenance diuretic regimen, additional 
doses of Furoscix can be prescribed during the 30-day study period as needed based on the 
presence of symptoms of congestion (dyspnea, edema, and/or excess weight gain) as 
determined by the investigator. No more than 7 doses of Furoscix is permitted during the 30-
day study period. Additional doses beyond 7 requires approval by the medical monitor. If 
diuretic modifications are made after Subjects’ are transitioned to their oral maintenance 
diuretic regimen, including additional doses of Furoscix in the treatment group or oral diuretics 
for the treatment as usual control group, the Subjects’ follow-up assessments and timing of 
those assessments will be based on the investigator’s clinical judgement.   
 
Subjects will be instructed on the use of the Furoscix Infusor by the investigator and/or study 
staff in accordance with the IFU and subject specific instructions. The initial dose of the study 
product may be administered in the clinic or at home on the day of enrollment. Additional 
doses will be provided to the subject for self-administration or administration by a caregiver in 
the home setting as directed by the investigator or study staff. 
5.6.   Procedures for Blinding  
This is an open label study. 
5.7.   Prior and Concomitant Therapy  
Prior and concomitant therapy will include all prescription medications and therapies. All 
information on prior (within the past 48 hours) and concomitant therapies will be recorded in 
the Subject’s source and on the Subject’s CRF. They should include the name of the therapy 
or drug and duration of the treatment (start and stop dates). 
5.8.   Prohibited Medications 
Concomitant use of any drugs known to interact with furosemide, including aminoglycoside 
antibiotics, ethacrynic acid, high doses of salicylates, cisplatin, tubocurarine, succinylcholine, 
chloral hydrate, phenytoin, methotrexate, indomethacin and lithium is not permitted. 
5.9.   Other Restrictions 
Subjects are advised to avoid strenuous physical activity or activities that could expose the 
device to moisture such as swimming, bathing or showering. Subjects will be informed that 
marked diuresis may ensue after activation, and that they should avoid travel, operating a 
vehicle or other situations without immediate access to bathroom facilities.    

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5.10.   Study Stopping Criteria 
The study may be stopped if the Investigator, Medical Monitor, Sponsor or IRB determines 
that subject safety may be compromised by continuing in the study. 
5.11.   Treatment Compliance 
Preparation, fill and placement of the Furoscix Infusor will be done in accordance with the 
study specific instructions which are based on the Instructions for Use of the study product as 
it exists at the time of the study. Site staff will perform product accountability (count the number 
of units used versus the number of days the subject was instructed to administer the study 
product). Study staff will also inspect the units and cartridge(s) used by the subjects to 
report/confirm they are empty.   
5.12.   Study Drug-Device Combination Accountability 
The study drug-device combination product will be handled in accordance with the procedures 
of this protocol. Only subjects enrolled in the study may receive study drug-device combination 
product, in accordance with applicable regulatory requirements.  
Study staff authorized to handle and store the drug-device combination product must keep an 
accurate accounting of the receipt, disposition and return of the study products received from 
the sponsor and dispensed to subjects. Drug-device combination product accountability will 
be assessed by the study monitor during periodic monitoring visits.  
6.   
STUDY PROCEDURES 
6.1.   Study Measurements and Assessments 
6.1.1.   
Assessment of Primary Endpoints 
• 
Improvement in a composite/combined morbidity/mortality endpoint at 30 days using 
the Finkelstein-Schoenfeld method.  
• 
CV death 
• 
HF hospitalization 
• 
Urgent ED/Clinic visit for worsening heart failure (defined as IV diuretics, 
augmentation of or new administration of metolazone) 
• 
Change in NT-proBNP from baseline at Day 7 
• 
Incidence of Adverse Events, Adverse Events of Special Interest, and Serious Adverse 
Events 
6.1.2.   
Assessment of Secondary Endpoints (through 30 days) 
• Days alive and HF event free days 
• Global Visual Analog Scale 
• Composite Congestion Score 
• 5-point Current Dyspnea Score 
• 7-point Dyspnea Score 
• Health-related quality of life (KCCQ-12) 
• Renal Function and Electrolytes 
• Weight  

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• Exercise tolerance (6MWT) 
• % Lung Fluid Measurement via Remote Dielectric Sensing (ReDS) 
6.1.3.   
Assessment of Adverse Events of Special Interest  
Subjects will have blood drawn at each clinic visit to monitor safety parameters. Subjects will 
specifically be monitored for the following adverse events: 
• 
Worsening kidney function, defined as increase of ≥ 0.5 mg/dl in serum creatinine 
• 
Hyperkalemia, defined as K > 5.5 mEq/L  
• 
Hypokalemia, defined as K < 3.5 mEq/L 
• 
Hypomagnesemia, defined as Mg < 1.5 mg/dL 
6.2.   Study Phases and Procedures 
A Time and Events Schedule is provided in Appendix 1. 
The Screening Phase will be conducted in the clinic. All Subjects who sign the informed 
consent form and satisfy the inclusion/exclusion criteria will be enrolled into the trial on the 
same day as screening. NT-proBNP will be sent to centralized laboratory. Drug administration 
will start on the day of screening and enrollment after randomization.  
The Treatment Phase will begin upon completion of screening through Day 29. Furoscix will 
be administered via the Furoscix Infusor whereby 80 mg is administered subcutaneously over 
5 hours in a biphasic regimen (30 mg in the first hour, followed 12.5 mg/hour for the 
subsequent 4 hours). Within a single 24-hour period, the 80 mg dose can be repeated at the 
discretion of the investigator > 2 hours after the completion of the first dose. Subjects should 
be transitioned back to their oral maintenance diuretic regimen when clinically indicated at the 
discretion of the investigator. After Subjects have been transitioned to their oral maintenance 
diuretic regimen, additional doses of Furoscix can be prescribed during the 30-day study 
period as needed based on the presence of congestion symptoms (dyspnea, edema, and/or 
excess weight gain) as determined by the investigator. No more than 7 doses of Furoscix is 
permitted during the 30-day study period. Additional doses beyond 7 requires approval by the 
medical monitor.    
Prior to leaving the clinic on Day 0, the Subject and/or caregiver will be trained by the study 
staff on how to prepare the study product and apply it to their abdomen and remove it once 
the infusion is completed. The initial dose of the study product may be administered in the 
clinic or at home on the day of enrollment. Additional doses will be provided to the Subject for 
self-administration or administration by a caregiver in the home setting as directed by the 
investigator or study staff.  
Subjects will be seen in the clinic on Day 0, 1, 3* and 7 and will receive phone calls on Days 
2, 4, 5, 6 and 17 where the study staff will assess subject’s signs and/or symptoms of 
congestion. These visits should all be conducted as early in the day as possible to 
accommodate the 5-hour infusion. If Day 3 falls on a Saturday or Sunday, subjects may be 
seen in the clinic and have Day 3 assessments completed on either Day 2 (Friday, if Day 3 
falls on Saturday) or Day 4 (Monday, if Day 3 falls on Sunday).  On Day 3 the subject will have 
a phone call visit.  
After the Day 7 clinic visit, subjects will be instructed to continue utilize provided equipment to 
weigh themselves and record their blood pressure and heart rate approximately same time 
each morning. If their symptoms worsen after they are transitioned to their oral maintenance 
diuretic regimen, they will be instructed to contact the investigator. Site staff will determine 

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based on the presence congestion symptoms (e.g. dyspnea, edema, and/or excess weight 
gain) if Subjects diuretic regimen should be modified, including additional doses of Furoscix 
in the treatment group or oral diuretics for the treatment as usual control group. The Subjects’ 
follow-up assessments and timing of those assessments will be based on the investigator’s 
clinical judgement. Unscheduled clinic and phone visits can be conducted as needed.      
The Follow-up Phase will consist of a one-day visit on Day 30 + 5 days post randomization 
(in-clinic visit).   
6.2.1.   
Screening (Day 0) 
The initial Screening assessment will be conducted the same day as the start of the Treatment 
Phase.  
The following procedures/assessments will be performed at Screening:   
• 
Informed consent (must be done prior to any of the following procedures) 
• 
Eligibility review 
• 
Medical history and Subject demographics (date of birth, gender, ethnic origin and 
race) 
• 
Limited Physical Exam including NYHA Classification  
• 
Composite Congestion Score (CCS) 
• 
5-point Current Dyspnea Score (using the script  - Appendix 7) 
• 
Weight and height (Calculate BMI)  
• 
Vital Signs 
• 
% Lung Fluid Measurement (ReDS) 
• 
Venous blood for clinical chemistries, hematology (run locally for eligibility), NT-
proBNP (run locally for eligibility; 2nd sample sent to a centralized laboratory for 
subjects who qualify to participate) 
• 
Urine pregnancy test on females of childbearing potential 
• 
Administer the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) 
• 
Administer the patient global assessment visual analog scale (VAS) 
• 
Administer Six Minute Walk Test (6MWT) 
• 
Assess for adverse events 
• 
Record concomitant medications (all medications taken within 48 hours) 
• 
Schedule next study visit (Day 1).   
 
6.2.2.   
Treatment Phase (Day 0) 
After the screening activities have been completed and laboratory analyses reviewed to 
confirm eligibility, the patient may be randomized (2:1) to receive either Furoscix or continued 
medical therapy with oral diuretics. Subjects randomized to continued medical therapy will 
follow the same schedule of assessments, excluding study product administration. 
 

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The initial dose of the study product should be administered after randomization. If 
randomized to Furoscix, product training with subject and/or caregiver will be conducted. The 
initial dose of the study product may be administered in the clinic or at home on the day of 
enrollment. Study staff will dispense additional doses of Furoscix. Subjects will be provided a 
Subject Diary in which to record any observed device issues and self-assessments that will 
be completed at home. 
 
The Subject will be reminded to use the provided equipment to weigh themselves and record 
their blood pressure and heart rate and complete the patient global assessment VAS upon 
returning home and first thing in the morning on Day 1. They will also be reminded to bring 
their study product (device) and Subject Diary back to the clinic on Day 1.   
 
6.2.3.   
Day 1 (In-Clinic Visit) 
Subjects will have been instructed to use the provided equipment to weigh themselves (scale) 
and record their blood pressure and heart rate and complete the patient global assessment 
VAS at home prior to presenting to the clinic. The clinic visit should occur early in the day 
(morning if possible) and have the following assessments completed or recorded: 
• 
Limited physical exam including NYHA Classification  
• 
CCS (Composite Congestion Score) 
• 
5-point Current Dyspnea Score (using the script  - Appendix 7) 
• 
7-point Dyspnea Score (using the script – Appendix 7) 
• 
Weight  
• 
Vital Signs 
• 
% Lung Fluid Measurement (ReDS) 
• 
Labs drawn for safety analyses 
• 
Patient global assessment VAS (should be done at home at approximately the time of 
weight is done) 
• 
6MWT 
• 
Review Subject Diary for completeness and any recorded device issues 
• 
Review any changes to concomitant medications since last visit 
• 
Assess for adverse events 
• 
Evaluate the clinical response to diuretic therapy and adjust as needed. Assess for 
transition back to oral maintenance diuretic therapy. For Furoscix subjects, additional 
doses may be prescribed and dispensed. For subjects receiving continued medical 
therapy, investigators will determine whether any modifications are needed. 
• 
Schedule the next study visit (Day 2 – via phone call; preferably in the AM) 
 
6.2.4.   
Day 2 (Phone Call) 
Site staff will contact the study subject guided by the telephone script in the morning and 
review/monitor the following: 

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• 
Ensure the subject has completed the Subject Diary and recorded device issues and 
used the provided equipment and recorded their weight and blood pressure and heart 
rate.   
• 
Ensure the subject has completed the patient global assessment VAS 
• 
Using the script (Appendix 7), perform the 5-point Current Dyspnea Score 
questionnaire with the subject 
• 
Using the script (Appendix 7), perform the 7-point Dyspnea Score questionnaire  with 
the subject 
• 
Any changes to concomitant medications since last visit are recorded 
• 
Any adverse events are reported/documented 
• 
The investigator will evaluate the clinical response to diuretic therapy and adjust as 
needed, including transition back to oral maintenance diuretic therapy. For Furoscix 
subjects, additional doses may be prescribed. For subjects receiving continued 
medical therapy, investigators will determine whether any modifications are needed. 
• 
Schedule the next visit (Day 3 - in-clinic visit). Remind the subject to use the provided 
equipment to weigh themselves and record their blood pressure and heart rate and 
complete the patient global assessment VAS in the morning. In addition, they should 
bring back the used study product well as the Subject Diary to the clinic visit. 
    
6.2.5.   
Day 3* (In-Clinic visit) 
If Day 3 falls on a Saturday or Sunday, subjects may be seen in the clinic and have Day 3 
assessments completed on either Day 2 (Friday, if Day 3 falls on Saturday) or Day 4 (Monday, 
if Day 3 falls on Sunday).  On Day 3 the subject will have a phone call visit. 
Subjects will have been instructed to use the provided equipment to weigh themselves (scale), 
record their blood pressure and heart rate and complete the patient global assessment VAS 
at home prior to presenting to the clinic. The clinic visit should occur early in the day (morning 
if possible) and have the following assessments completed: 
• 
Limited physical exam including NYHA Classification 
• 
CCS (Composite Congestion Score)  
• 
5-point Current Dyspnea Score (using the script  - Appendix 7) 
• 
7-point Dyspnea Score (using the script – Appendix 7) 
• 
Weight  
• 
Vital Signs 
• 
% Lung Fluid Measurement (ReDS) 
• 
Labs drawn for safety analyses (local lab) and NT-proBNP (send to centralized lab) 
• 
Patient global assessment VAS (should be done at home at approximately the time of 
weight/blood pressure monitoring is done) 
• 
Review Subject Diary for completeness and any recorded device issues 
• 
Review any changes to concomitant medications since last visit 
• 
Assess for adverse events 

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• 
Evaluate the clinical response to diuretic therapy and adjust as needed. Assess for 
transition back to oral maintenance diuretic therapy. For Furoscix subjects, additional 
doses may be prescribed. For subjects receiving continued medical therapy, 
investigators will determine whether any modifications are needed.   
• 
Dispense study product for Days 4, 5 and 6 (if applicable) 
• 
Schedule the next study visits (Days 4, 5, and 6 – via phone call) 
6.2.6.   
Days 4, 5, and 6 (Phone Calls) 
Site staff will contact the study subject in the morning guided by the telephone script and 
review/monitor the following: 
• 
Ensure the subject has completed the Subject Diary and recorded device issues and 
used the provided equipment and recorded their weight and blood pressure and heart 
rate.   
• 
Ensure the subject has completed the patient global assessment VAS 
• 
Using the script (Appendix 7), perform the 5-point Current Dyspnea Score 
questionnaire with the subject 
• 
Using the script (Appendix 7), perform the 7-point Dyspnea Score questionnaire with 
the subject 
• 
Record any changes to concomitant medications since last visit 
• 
Assess for any adverse events 
• 
Evaluate the clinical response to diuretic therapy and adjust treatment as needed.  
Assess for transition back to oral maintenance diuretic therapy. For Furoscix subjects, 
additional doses may be prescribed. For subjects receiving continued medical therapy, 
investigators will determine whether any modifications are needed.   
• 
Schedule the next visits (on Days 4 and 5 – via phone call). On Day 6 remind the 
Subject the Day 7 visit will be an in-clinic visit and they should use the provided 
equipment to weigh themselves and complete the patient global assessment VAS in 
the morning and to bring back all study product (device and cartridges, used and 
unused) as well as Subject Diary to the clinic visit. 
 
6.2.7.   
Day 7 (In-Clinic Visit) 
Subjects will have been instructed to use the provided equipment to weigh themselves (scale) 
and record their blood pressure and heart rate and complete the patient global assessment 
VAS at home prior to presenting to the clinic. The clinic visit should occur early in the day 
(morning if possible) and have the following assessments completed or recorded: 
• 
Limited physical exam including NYHA Classification 
• 
CCS (Composite Congestion Score)  
• 
5-point Current Dyspnea Score (using the script  - Appendix 7) 
• 
7-point Dyspnea Score (using the script – Appendix 7) 
• 
Weight  
• 
Vital Signs 

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• 
% Lung Fluid Measurement (ReDS) 
• 
Labs drawn for safety analyses (local lab) and NT-proBNP (send to centralized lab) 
• 
KCCQ-12 
• 
Patient global assessment VAS (should be done at home at approximately the time 
weight is measured) 
• 
6MWT 
• 
Review Subject Diary for completeness and any recorded device issues 
• 
Review any changes to concomitant medications since last visit 
• 
Assess for adverse events 
• 
Schedule the next study visits (Day 17 phone call and Day 30 clinic visit) 
• 
Subjects should be reminded to continue to complete the Study Diary and use the 
provided equipment to weigh themselves and record their blood pressure and heart 
rate at home each morning through the Day 30 visit. The subject should also be 
reminded to complete the patient global assessment VAS the morning of Day 17 and 
Day 30. The equipment should be returned at the Day 30 visit. 
• 
Subjects should be instructed to call the study site if they have any worsening heart 
failure symptoms due to congestion, go to the Emergency Department or are admitted 
to the hospital. 
 
6.2.8.   
Day 17 ± 3 (Telephone Call Follow-Up) 
A telephone call follow-up guided by the telephone script will be conducted on Day 17 ± 3 
days. The primary purpose of this call is to assess Subject’s congestion symptoms to 
determine if a change in diuretic management is needed and assess whether the Subject has 
experienced or is experiencing a study related adverse event. The following assessments will 
be performed: 
• 
Ensure the subject has completed the Subject Diary and recorded device issues and 
used the provided equipment and recorded their weight and blood pressure and heart 
rate.   
• 
Ensure the subject has completed the patient global assessment VAS (should be done 
at home at approximately the time of weight is done) 
• 
Using the script (Appendix 7), perform the 5-point Current Dyspnea Score 
questionnaire with the subject 
• 
Using the script (Appendix 7), perform the 7-point Dyspnea Score questionnaire with 
the subject 
• 
Record any changes to concomitant medications since last visit 
• 
Assess for any adverse events 
• 
Evaluate the clinical response to diuretic therapy and adjust treatment as needed.  For 
Furoscix subjects, additional doses may be prescribed (after an in-clinic evaluation). 
More than 7 doses of Furoscix in the 30-day study period require approval by the 
medical monitor. For subjects receiving continued medical therapy with oral diuretics, 
investigators will determine whether any modifications are needed.   

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• 
Determination if an unscheduled in-clinic visit or an unscheduled phone call is 
indicated and schedule as appropriate.   
 
6.2.9.   
Day 30 ± 5 (In-Clinic Visit) 
Subjects will be instructed to use the provided equipment to weigh themselves (scale) and 
record their blood pressure and heart rate and complete the patient global assessment VAS 
at home prior to presenting to the clinic. They should return the equipment to the clinic at this 
visit. The following assessments will be completed or recorded: 
• 
Limited physical exam including NYHA Classification  
• 
CCS (Composite Congestion Score) 
• 
5-point Current Dyspnea Score (using the script - Appendix 7) 
• 
7-point Dyspnea Score (using the script – Appendix 7) 
• 
Weight  
• 
Vital Signs 
• 
% Lung Fluid Measurement (ReDS) 
• 
Labs drawn for safety analyses (local lab) and NT-proBNP (send to centralized lab) 
• 
KCCQ-12 
• 
Patient global assessment visual analog scale (should be done at home at 
approximately the time of weight is done)  
• 
6MWT 
• 
Review Subject Diary for completeness and any recorded device issues 
• 
Review any changes to concomitant medications since last visit 
• 
Assess for adverse events 
• 
Collect any used and unused study product since the last in-clinic visit 
 
6.2.10.   
Unscheduled Visit (In-Clinic Visit) 
If subjects experience worsening signs and symptoms they can be seen in the clinic as an 
unscheduled visit. For subjects presenting for an unscheduled visit the following assessments 
may be performed:   
• 
Limited physical exam including NYHA Classification 
• 
CCS (Composite Congestion Score)  
• 
5-point Current Dyspnea Score (using the script  - Appendix 7) 
• 
7-point Dyspnea Score (using the script – Appendix 7) 
• 
Weight  
• 
Vital Signs 
• 
% Lung Fluid Measurement (ReDS)  
• 
Labs drawn for safety analyses (local laboratory) and NT-proBNP (send to centralized 
laboratory) 

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• 
Review Subject Diary for completeness and any recorded device issues 
• 
Review any changes to concomitant medications since last visit 
• 
Assess for adverse events 
• 
Evaluate the clinical response to diuretic therapy and adjust as needed. For Furoscix 
subjects, additional doses may be prescribed. More than 7 doses of Furoscix in the 
30-day study period require approval by the medical monitor. For subjects receiving 
continued medical therapy with oral diuretics, investigators will determine whether any 
modifications are needed. If diuretic modifications are made after Subjects’ are 
transitioned to their oral maintenance diuretic regimen, including additional doses of 
Furoscix in the treatment group or oral diuretics for the treatment as usual control 
group, the Subjects’ follow-up assessments and timing of those assessments will be 
based on the investigator’s clinical judgement. Additional unscheduled clinic and 
phone visits can be conducted as needed. 
 
6.2.11.   
Unscheduled Phone Visit 
At the discretion of the investigator, or if subjects experience worsening signs and symptoms, 
they can speak to the research staff via phone as an Unscheduled Phone Visit. For an 
Unscheduled Phone Visit the following assessments may be performed:   
• 
Ensure the subject has completed the Subject Diary and recorded device issues and 
used the provided equipment and recorded their weight and blood pressure and heart 
rate.   
• 
Using the script (Appendix 7), perform the 5-point Current Dyspnea Score 
questionnaire with the subject 
• 
Using the script (Appendix 7), perform the 7-point Dyspnea Score questionnaire with 
the subject 
• 
Record any changes to concomitant medications since last visit 
• 
Assess for any adverse events 
• 
Discuss with investigator if Subject requires modifications to their oral maintenance 
diuretic regimen based on the presence of congestion symptoms (e.g. dyspnea, 
edema, and/or excess weight gain), including additional doses of Furoscix in the 
treatment group or oral diuretics for the treatment as usual control group and if the 
Subject should come in for an unscheduled in-clinic evaluation.  
• 
If an unscheduled in-clinic visit is indicated, schedule as appropriate.   
 
6.2.12.   
NT-proBNP Assessments  
Blood samples will be obtained by direct venipuncture at screening on Day 0, Day 3, Day 7, 
Day 30 and on unscheduled in-clinic visit (first unscheduled in-clinic visit only).  
A total of 3.5 mL of blood will be collected in pre-labeled tubes. Blood samples will be 
processed and stored in appropriately labeled cryotubes at minus 70˚C or colder until shipped 
to the bioanalytical laboratory as described in the Laboratory Manual. Day 0 NT-proBNP must 

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be done locally to determine eligibility but a 2nd sample will be sent to the centralized laboratory 
and that result is the one that will be used in the analysis. 
6.2.13.   
Clinical Laboratory Tests 
All routine samples will be analyzed by a local licensed clinical laboratory. The clinical 
laboratory tests are as follows: 
• 
Blood Clinical Chemistry:  blood urea nitrogen (BUN), creatinine, sodium, potassium, 
chloride, bicarbonate, magnesium 
• 
Urine pregnancy test:  βhCG test. 
The Investigator is responsible for determining if out-of-range laboratory values are clinically 
significant or not. All clinically significant values will be followed until stabilization, resolution, 
or loss to follow-up or until no further improvement is expected. 
6.2.14.   
Physical Examinations 
A limited physical examination will be performed consisting of assessments of the following: 
skin of abdominal area, lungs/chest, heart, abdomen and periphery.   
6.2.15.   
Heart Failure Symptom Scoring 
The New York Heart Association (NYHA) Functional Classification will be used in this study. 
New York Heart Association (NYHA) Functional Classification 
NYHA 
Class 
Symptoms 
I 
Patients have cardiac disease but without the resulting limitations of 
physical activity. Ordinary physical activity does not cause undue fatigue, 
palpitation, dyspnea or anginal pain. 
II 
Patients have cardiac disease resulting in slight limitation of physical 
activity. They are comfortable at rest. Ordinary physical activity results in 
fatigue, palpitation, dyspnea or anginal pain. 
III 
Patients have cardiac disease resulting in marked limitation of physical 
activity. They are comfortable at rest. Less than ordinary physical activity 
causes fatigue, palpitation, dyspnea or anginal pain. 
IV 
Patients have cardiac disease resulting in inability to carry on any physical 
activity without discomfort. Symptoms of cardiac insufficiency or of the 
anginal syndrome may be present even at rest. If any physical activity is 
undertaken, discomfort is increased.  
 
6.2.16.   
Composite Congestion Score (CCS) 
CCS is a 4-point grading scale ranging from 0 to 3 for investigator-assessed signs and 
symptoms of congestion (dyspnoea, orthopnoea, fatigue, rales, pedal oedema, and JVD) 
(Appendix 4). This assessment will be done and documented on Days 0, 1, 3, 7, 30 and 
during any unscheduled in-clinic visit.  
 

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6.2.17.   
Vital Signs 
Vital signs will be conducted during screening (Day 0). Vital signs will include respiratory rate 
(respirations per minute), blood pressure (mmHg) and heart rate (beats per minute [bpm]). 
Vital signs will be obtained after the Subject has been resting in sitting position for 5 minutes.  
Height and weight will be collected for BMI. Height collected Day 0 only.    
On Days 1-30 weight, heart rate and blood pressure will be obtained by the Subject at home 
using the equipment supplied at screening and recorded daily in the  Subject Diary. These will 
be collected at home in the morning even for those days where visits to the clinic are required.   
Vital signs (respiratory rate, blood pressure, heart rate) will also be collected at each in-clinic 
visit. Weight will also be collected at each in-clinic visit. 
6.2.18.   
% Lung Fluid Measurement (ReDS) 
The ReDS System is a non-invasive diagnostic device consisting of a Bedside Console 
connected to a wearable Sensor Unit that is used for the measurement of lung fluid. The 
system is FDA cleared for use by qualified healthcare practitioners, under the direction of a 
physician, in hospitals, hospital-type facilities and home environments, for the non-invasive 
monitoring and management of patients with fluid management problems in a variety of 
medically accepted clinical applications.   
 
The ReDS System is indicated for patients: 
• 
With fluid management problems 
• 
Taking diuretic medications 
• 
Living with heart failure 
• 
Recovering from a coronary artery disease-related event 
 
The Sensor Unit consists of two sensors and a positioner. One sensor is placed on the 
patient’s upper right chest through light clothing and another on the upper-right part of the 
patient’s back. The Sensor Unit is connected by a non-detachable cable to the Bedside 
Console. Low power electromagnetic (EM) signals are emitted and pass through the thorax 
and software in the console calculates an average dielectric coefficient that reflects the 
percentage of lung tissue fluid content. 
 
The system provides an on-screen reading within 45 seconds. Measurements are recorded 
in units of percent (%), representing the percent of lung tissue volume that is occupied by 
fluid. The normal value of lung fluid volume ranges between 20% and 35%. The full range of 
lung fluid volume provided by the ReDS system spans from 15% to 60%. 
 
Study Staff will be trained on the use of the ReDS system. 
       
6.2.19.   
Patient Global Assessment Visual Analog Scale 
The patient global assessment visual analog scale is a patient reported assessment of how 
good or bad a patient feels their health is that day. It is reported on a visual scale of 0-100 
with 100 being the best health they can imagine and 0 being the worst health they can 
imagine. The EQ-VAS tool will be utilized for this assessment. This patient reported 
assessment will be obtained on Days 0-7, Day 17 and Day 30. This assessment should be 
done in the morning at approximately the same time as weight is being measured. 

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6.2.20.   
5-Point Current Dyspnea Score 
The 5-Point Current Dyspnea Questionnaire is a single-item, self-administered instrument 
that quantifies current symptoms of dyspnea (see Appendix 5). This will be administered 
after a verbatim script is read by study staff (see Appendix 7). This assessment will be done 
on Days 1, 2, 3, 4, 5, 6, 7, 17 and 30 and during an unscheduled in-clinic or phone visit. 
6.2.21.   
7-Point Dyspnea Score 
The 7-Point Dyspnea Questionnaire is a single-item, self-administered instrument that 
quantifies changes in dyspnea symptoms since initiation of study product (see Appendix 6).  
This will be administered after a verbatim script is read by study staff (see Appendix 7). This 
assessment will be done on Days 1, 2, 3, 4, 5, 6, 7, 17 and 30 and during an unscheduled 
in-clinic or phone visit. 
6.2.22.   
Kansas City Cardiomyopathy Questionnaire – 12 (KCCQ-12) 
The KCCQ-12 is a shortened version of the original KCCQ with 23 questions. This 
questionnaire is a patient reported assessment designed to capture symptom frequency, 
physical and social limitations, and quality of life impairment as a result of heart failure, as 
well as an overall summary score. This assessment will be done on Days 0, 7 and 30. 
6.2.23.   
Six Minute Walk Test (6MWT) 
The 6MWT is a test to measure the distance a subject can walk over a total of six minutes. 
The Subject is instructed to walk as far as possible in 6 minutes on a hard, flat surface. If 
needed, the Subject may rest and pace themselves during this time as they move back and 
forth along a marked path. This assessment is done on Days 0, 1, 7 and 30. 
6.2.24.   
Subject Diary 
During the study period and for all treatment days, these data will be recorded in the Subject 
Diary by the Subject and reported to the study staff during phone contacts: 
• 
Infusor Kit serial number (Furoscix treatment group) 
• 
Infusor start and stop dates/times for each dose (Furoscix treatment group) 
• 
Oral diuretic use in addition to the study drug (name, dose, date, time) 
• 
Adverse events and/or device issues should be noted in the comments/issues 
section of the diary.   
o 
See section 7.1 for the definition of an adverse event.   
o 
A device issue is defined as anything the user states occurred that resulted in 
the device not functioning as expected.  
 
6.2.25.   
Study Product Training 
Study Staff will be trained on the use of the study product, subject/caregiver considerations, 
and methods for training subjects and/or their caregivers who are enrolled into the study. 
The study staff and enrolled subjects will be trained using the Instructions for Use.   
7.   
ADVERSE EVENTS  
The Investigator is responsible for the detection and documentation of events meeting the 
definition of an AE or SAE as provided in this protocol. AEs will be assessed continuously 

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through the last study visit unless the nature of the AE or SAE requires continued 
monitoring. All AEs are recorded as mild, moderate or severe, and as Not Related, Possibly 
Related, Probably Related, or Definitely Related to the Investigational Product.   
7.1.   Definition of an Adverse Event (AE) 
An Adverse Event (AE) is any untoward medical occurrence associated with the use of an 
Investigational Product (IP) in humans, whether considered related to the IP. An adverse 
event (also referred to as an adverse experience) can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of an Investigational Product (IP) and does not imply any judgment 
about causality. An adverse event can arise with any use of the IP (e.g., off-label use, use in 
combination with another drug) and with any route of administration, formulation, or dose, 
including an overdose. 
A “pre-existing” condition is one that is present prior to IP administration and is reported as 
part of the Subject’s medical history. Pre-existing conditions should be reported as AEs only 
if the frequency, intensity, or character of the pre-existing condition worsens during the 
study. 
Laboratory or functional test abnormalities generally are not considered AEs unless they are 
associated with clinical signs or symptoms or require medical intervention. A laboratory 
abnormality (e.g. a clinically significant change detected on clinical chemistry, hematology, 
urinalysis) or functional test abnormality (e.g. a clinically significant change detected on 
ECG, pulse oximetry, or spirometry) that is independent from a known underlying medical 
condition and that requires medical or surgical intervention, or leads to IP interruption or 
discontinuation, must be considered an AE. 
All AEs judged to be clinically significant, including clinically significant laboratory results, 
ECG and functional test abnormalities, will be followed until resolution or return to baseline 
or until no further improvement is expected. 
An AE does include any: 
• 
Exacerbation of a pre-existing illness. 
• 
Increase in frequency or intensity of a pre-existing episodic event or condition. 
• 
Condition detected or diagnosed after study product placement and/or drug administration 
even though it may have been present prior to the start of the study. 
• 
Continuous persistent disease or symptoms present at baseline that worsen following the 
start of the study. 
An AE does not include a/an: 
• 
Medical or surgical procedure (e.g., surgery, endoscopy, tooth extraction, transfusion); the 
condition that leads to the procedure is an AE. 
• 
Pre-existing diseases or conditions present or detected at the start of the study that do not 
worsen. 
• 
Situations where an untoward medical occurrence has not occurred (e.g., hospitalization 
for cosmetic elective surgery, social and/or convenience admissions). 

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• 
Overdose of either study drug or concurrent medication without any signs or symptoms. 
• 
Hospitalization for elective treatment of a pre-existing condition that did not worsen during 
the study is not considered an AE. 
 
7.2.   Definition of a Serious Adverse Event (SAE) 
An SAE is any AE occurring at any dose that results in any of the following outcomes: 
a. Death. 
b. A life-threatening AE. 
• 
NOTE: Life-threatening means that the Subject was, in the view of the 
Investigator, at immediate risk of death from the event as it occurred. This 
definition does not include an event that, had it occurred in a more severe form, 
might have caused death. 
c. Inpatient hospitalization or prolongation of existing hospitalization. 
• 
NOTE: Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization, the event is an SAE. 
• 
NOTE: “Inpatient” hospitalization means the Subject has been formally 
admitted to a hospital for medical reasons. This may or may not be overnight.  
It does not include presentation at a “casualty” or emergency room. 
d. A disability/incapacity. 
• 
NOTE: The term disability means a substantial disruption of a person’s ability 
to conduct normal life functions. This definition is not intended to include 
experiences of relatively minor medical significance such as uncomplicated 
headache, nausea, vomiting, diarrhea, influenza, accidental trauma (i.e., 
sprained ankle) that may interfere or prevent everyday life functions but do not 
constitute a substantial disruption. 
e. A congenital anomaly in the offspring of a Subject who received drug. 
f. 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical 
judgment, they may jeopardize the Subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an 
emergency room or at home, blood dyscrasias or convulsions that do not result in 
Subject hospitalization, or the development of drug dependency or drug abuse. 
• 
Medical and scientific judgment should be used in deciding whether prompt 
reporting is appropriate in this situation. 
7.3.   Definition of an Adverse Event of Special Interest (AESI) 
An adverse event of special interest (serious or non-serious) is one of scientific and medical 
concern specific to the sponsors program, for which ongoing monitoring and rapid 

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communication by the investigator to the sponsor can be appropriate. Such an event might 
warrant further investigation in order to characterize and understand it. 
7.4.   Severity of AEs/SAEs 
Severity (mild, moderate, or severe) of each AE/SAE must be assessed by the Investigator or 
designee. The following criteria should be considered when assessing severity: 
 
 
 
 
 
7.5.   Outcome of AE/SAEs 
o Not Recovered/Not Resolved: One of the possible results of an adverse event 
outcome that indicates that the event has not improved or recuperated.   
o Recovered/Resolved: One of the possible results of an adverse event outcome 
that indicates that the event has improved or recuperated.  
o Recovered/Resolved with Sequelae: One of the possible results of an adverse 
event outcome where the subject recuperated but retained pathological 
conditions resulting from the prior disease or injury.  
o Recovering/Resolving: One of the possible results of an adverse event outcome 
that indicates that the event is improving.  
o Unknown: Not known, not observed, not recorded, or refused. 
o Fatal: The termination of life as a result of an adverse event 
 
7.6.   Assessment of Relatedness to Study Product  
The Investigator will assess each AE and SAE for causality based on their best medical 
judgment, the observed symptoms associated with the event, and the available information 
on the Investigational Product (IP). The relatedness guidance provided below can be used to 
assist in determining the relationship of the IP to the AE or SAE. However, it is ultimately the 
investigator’s responsibility to determine the relationship based on their best medical 
judgment, knowledge, and experience. 
 
• 
Not Related:  Based upon available information regarding subject history, disease 
process, relationship of adverse event to dosing and drug pharmacology, there is no 
reasonable relationship between the IP and the adverse event. 
• 
Possibly Related:  Relationship exists between the adverse event and IP, when the 
adverse event follows a reasonable sequence from the time of the IP administration, 
• 
Mild 
The symptom is barely noticeable to the Subject and does not 
influence performance or functioning.   
• 
Moderate 
The symptom is of sufficient severity to make the Subject 
uncomfortable, and performance of daily activities is influenced.  
Treatment for the symptom may be needed. 
• 
Severe 
The symptom causes severe discomfort. Treatment for the 
symptom may be necessary. 

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but could also have been produced by the subject’s clinical state or by other drugs 
administered to the patient. 
• 
Probably Related:  Relationship exists between the adverse event and the IP when 
the adverse event follows a reasonable sequence from the time of IP administration, 
follows a known response pattern of the drug class, is confirmed by improvement on 
stopping the IP and the IP is the most likely of all causes. 
• 
Definitely Related:  Relationship exists between the adverse event and the IP when 
the adverse event follows a reasonable sequence from the time of the IP administration, 
follows a known response pattern of the drug class, is confirmed by improvement on 
stopping the IP and no other reasonable cause exists. 
 
7.7.   Method, Frequency, and Time Period for Detecting Adverse Events and 
Serious Adverse Events 
At appropriate intervals, Subjects should be assessed for AEs and SAEs as in Section 6.2.  
7.7.1.   
Timeframes for Reporting SAEs 
Prompt notification of the sponsor regarding SAEs is essential so that ethical and regulatory 
responsibilities and legal obligations can be satisfied. The Investigator must report SAEs 
according to the following time frames:    
• 
Initial notification of all SAEs based on the available information must be provided to 
the sponsor or designee within 24 hours of the investigational site learning of the 
event. (Initial notification within 24 hours of Death and life-threatening events is 
extremely important).  
o Follow-up information when available must be sent to the sponsor or 
designee within 48 hours of receipt of the information by the investigational 
site.  
7.7.2.   
SAE Information to Report 
At a minimum, SAE reports must contain the Subject ID, the serious adverse event term, onset 
date, relationship to study product, and a brief narrative of the event. Please note that 
relationship to study product/causality is very important and must be included in the initial 
report as it may impact expedited regulatory reporting requirements for the event. 
Copies of medical records will be requested. However, it is not acceptable for the 
Investigator to send photocopies of the Subject’s medical records in lieu of completion 
of the appropriate AE/SAE pages. For medical records submitted, all Subject personal 
identifiers must be completely and thoroughly redacted prior to submission. 
7.7.3.   
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
AEs and SAEs 
The Investigator should exercise his or her medical and scientific judgment in deciding 
whether an abnormal laboratory finding, or other abnormal assessment is clinically significant. 
Abnormal laboratory findings (e.g., clinical chemistry, hematology, and urinalysis) or other 
abnormal assessments (e.g., vital signs) that are judged by the Investigator as clinically 

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significant must be recorded as AEs or SAEs if they meet the definition of an adverse event.  
Clinically significant abnormal laboratory findings or other abnormal assessments that are 
detected after study product administration or that are present before study product 
administration but worsen after study product administration should be assessed for AE 
criteria. 
7.7.4.   
Documenting AEs and SAEs 
All adverse events, including SAEs that occur after dosing of study product must be 
documented in the Subject's medical records and on the CRF.   
The Investigator should attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. In such cases, the diagnosis should be 
documented as the AE and/or SAE term. 
7.7.5.   
Regulatory/Ethics reporting requirement  
The Investigator must comply with the applicable local regulatory requirements related to the 
reporting of SAEs to the IRB. 
7.7.6.   
Follow-up of AEs and SAEs 
All AEs and SAEs documented at a previous visit/contact that are designated as ongoing will 
be reviewed at subsequent visits/contacts. AEs and SAEs will be followed until the last study 
visit unless the nature of the AE or SAE requires continued monitoring. If a Subject dies during 
participation in the study or during a recognized follow-up period, a copy of any post-mortem 
findings, including histopathology, should be obtained, if available, and forwarded to 
scPharmaceuticals or designee. New or updated information will be recorded on the originally 
completed SAE Report Form with all changes electronically signed/dated by the Investigator 
or designee.   
7.7.7.   
Post-study AEs and SAEs 
Should the Investigator learn of an AE or SAE occurring within 30 days after a Subject 
completes the study, the event should be reported if it is considered related to study product.     
7.7.8.   
Medical Monitor 
SAEs and other medical matters can be discussed with the Medical Monitor.  
8.   
STATISTICS  
8.1.   General Statistical Issues 
This is a multicenter, randomized, open label, controlled study evaluating the effectiveness 
and safety of the Furoscix Infusor vs. continued medical therapy in patients with chronic heart 
failure and fluid overload requiring augmentation in diuretic therapy outside of the acute care 
setting.  
Unless otherwise specified, all safety data, effectiveness data, demographic data, and other 
baseline clinical characteristics will be summarized by treatment group. Continuous data will 
be summarized by reporting the number of observations, mean, standard deviation, minimum, 
median, and maximum values. Categorical data will be described using frequency tables 
showing the number and percentage of subjects falling within a particular category. Shift 
tables will be given where appropriate to show change compared to baseline values. 

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Statistical analysis tests will be performed at a two-sided alpha level of 0.05, unless otherwise 
specified. Between-group analyses of baseline characteristics will employ descriptive 
statistics as described in the SAP. Mortality and morbidity events will be assessed using 
appropriate statistical tests as described in the SAP. The primary endpoint will be measured 
using the Finkelstein-Schoenfeld Method, comparing components of the composite endpoint 
hierarchically, as described in the SAP. There will be no imputation of missing data. 
8.2.   Analysis Populations 
 
Intent-to-Treat (ITT): All randomized subjects. 
 
Safety: All randomized subjects who received at least one dose of the Investigational 
Product. 
 
Per-Protocol (PP): All randomized subjects who received at least one dose of the 
Investigational Product AND completed the Day 30 clinic visit assessments AND 
have a Day 7 NT-proBNP value available for analysis.  
 
All effectiveness analyses, including the primary endpoint and baseline characteristics will 
be performed on the ITT and Per-Protocol populations as further defined in the SAP. Safety 
analyses will be performed on the safety population. 
8.3.   Baseline Characteristics and Subject Disposition 
Subject disposition (e.g., the number of Subjects enrolled, completed, and discontinued 
overall and by reason) will be summarized using the categorical descriptive statistics 
described in §8.1 above. Overall baseline clinical and demographic data will be summarized 
using descriptive statistics and compared between treatments using appropriate statistical 
tests as defined in the SAP.  
8.4.   Effectiveness Analyses 
The following endpoints will be assessed. 
8.4.1.   
Primary Endpoints  
The primary analysis compares the components of the primary composite endpoint 
hierarchically using the Finkelstein-Schoenfeld Method. Each patient is compared to all other 
patients with respect to each of the following endpoints at 30 days:  
 
 
CV death 
 
HF hospitalization 
 
Urgent ED/Clinic visit for worsening heart failure (defined as IV diuretics, augmentation 
of or new administration of metolazone) 
 
Change in NT-proBNP from baseline at Day 7. 
 
Each endpoint will be descriptively presented as well. 
 
Incidence of Adverse Events, Adverse Events of Special Interest, and Serious Adverse Events 
will be described in each group. 
 

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8.4.2.   
Secondary Endpoints 
Descriptive and statistical comparisons of treatment vs. control group will be conducted for 
each secondary endpoint at a two-sided 0.05 level of significance. The following secondary 
endpoints will be compared between treatment groups on the ITT and Per-Protocol 
populations as described in SAP: 
 
Days alive and heart failure event-free (hospitalization for heart failure or ED visits for 
heart failure) over 30 days.  
 
Changes from baseline in patient global assessment via visual analog scale (VAS) 
across follow-up timepoints. 
 
Changes from baseline in composite congestion score across follow-up timepoints.  
 
Changes from baseline in 5-point Current Dyspnea Score across  follow-up timepoints. 
 
7-point Dyspnea Score across follow-up timepoints.  
 
Changes from baseline in health-related quality of life measured by the KCCQ-12 
Short Form Summary Score across follow-up timepoints. 
 
Changes from baseline in serum creatinine across follow-up timepoints.  
 
Changes from baseline in ambulatory body weight across follow-up timepoints.  
 
Changes from baseline in Six-Minute Walk Test (6MWT) across follow-up timepoints.  
 
Changes from baseline in the ReDS Lung Fluid Measurement across follow-up time 
points. 
 
8.5.   Interim Analysis 
There will be no formal interim analysis. 
8.6.   Safety Analyses 
Safety analysis will be performed on the safety population. No imputation will be performed 
for missing data. The incidence (number and percentage of subjects) of adverse events will 
be presented overall and by MedDRA System Organ Class (SOC) and Preferred Term (PT) 
for each treatment group. This analysis will be repeated for serious adverse events, for 
treatment-related adverse events, adverse events of special interest and for adverse events 
leading to premature study withdrawal. 
Descriptive statistics at each time point will be presented for laboratory variables, vital signs, 
and body weight, stratified by treatment group.   
8.7.   Subgroup Analysis 
The primary endpoint will be compared between treatment groups within pre-specified 
subgroups defined in the SAP. There will be no formal treatment comparisons within 
subgroups. The purpose of the analysis within subgroups is not to show statistical significance 
between treatments within subgroups, but to assess the consistency of treatment effect 
across subgroups. 

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9.   
RESPONSIBILITIES 
9.1.   Investigator Responsibilities 
9.1.1.   
Good Clinical Practice 
The Investigator will ensure that this study is conducted in full compliance with the principles 
of the “Declaration of Helsinki” (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and 
South Africa), ICH guidelines, or with the laws and regulations of the country in which the 
research is conducted, whichever affords the greater protection to the study Subject. For 
studies conducted under a United States IND, the Investigator will ensure that the basic 
principles of “Good Clinical Practice,” as outlined in 21 CFR 312, subpart D, “Responsibilities 
of Sponsors and Investigators,” 21 CFR, part 50, 1998, and 21 CFR, part 56, 1998, are 
adhered to.  
9.1.2.   
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Approval 
This protocol and any accompanying material to be provided to the Subject (such as 
advertisements, Subject information sheets, or descriptions of the study used to obtain 
informed consent) will be submitted, by the Investigator, to an IRB [or] EC. Approval from the 
IRB/EC must be obtained before starting the study and should be documented in a letter to 
the Investigator specifying the protocol number, protocol version, documents reviewed, and 
date on which the committee met and granted the approval. 
Any modifications or amendment to the protocol must also be submitted to the IRB/EC for 
approval prior to implementation. 
9.1.3.   
Informed Consent 
It is the responsibility of the Investigator or designee to obtain written informed consent from 
each individual participating in this study after adequate explanation of the aims, methods, 
objectives, and potential hazards of the study and prior to undertaking any study-related 
procedures. The Investigator or designee must utilize an IRB-approved consent form for 
documenting written informed consent. Each informed consent will be appropriately signed 
and dated by the Subject and the person obtaining consent. A copy of the signed consent 
form will be provided to the Subject. 
9.1.4.   
Confidentiality 
All information about the nature of the proposed investigation provided by the Sponsor or 
study monitor to the Principal Investigator (with the exception of information required by law 
or regulations to be disclosed to the IRB, the Subject, or the appropriate regulatory authority) 
must be kept in confidence by the Principal Investigator. 
The Investigator must assure that Subjects’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only Subject initials and an identification 
code (i.e., not names) should be recorded on any form submitted to the Sponsor and IRB.  
The Investigator must keep a Subject log showing codes and, names, for all enrolled in the 
trial. 

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9.1.5.   
Compensation, Insurance, and Indemnity 
Information regarding compensation, insurance, and indemnity is addressed in the Clinical 
Trial Research Agreement. 
9.1.6.   
Study Files and Retention of Records 
The Investigator must maintain adequate and accurate records to enable the conduct of the 
study to be fully documented and the study data to be subsequently verified. These 
documents should be classified into 2 separate categories including (although not limited to) 
the following: (1) Investigator’s study file, and (2) Subject clinical source documents. 
The Investigator’s study file will contain the protocol/amendments, IRB/EC approval, informed 
consent, drug accountability records, staff curriculum vitae, medical licenses as applicable, 
financial disclosure forms, local laboratory documentation, screening and enrollment log, and 
other appropriate documents and correspondence. 
Subject clinical source documents would include (although is not limited to) the following: 
Subject hospital/clinic records, physician’s and nurse’s notes, laboratory reports, worksheets, 
consultant letters, etc.   
All clinical study documents must be retained by the Investigator until at least two years after 
the last approval of a marketing application in an International Conference on Harmonization 
(ICH) region (i.e., United States, Europe, or Japan) and until there are no pending or 
contemplated marketing applications in an ICH region; or, until two years after the IND is 
discontinued and regulatory authorities have been notified. The Investigator must notify 
scPharmaceuticals prior to destroying any clinical study records. 
Should the Investigator wish to move study records to another location, arrangements must 
be made to store these in sealed containers so that they can be returned sealed to the 
Investigator in case of a regulatory audit. Where source documents are required for the 
continued care of the Subject, appropriate copies should be made for storage outside of the 
site. 
9.1.7.   
Case Report Forms 
For each Subject who signs informed consent, a CRF must be completed and signed (or 
electronically signed if eCRF) by the principal Investigator or sub-Investigator within a 
reasonable time period after data collection. This also applies to records for those Subjects 
who fail to complete the study. If a Subject withdraws from the study, the reason must be 
noted on the CRF. If a Subject is withdrawn from the study because of a treatment-limiting 
AE, thorough efforts should be made to clearly document the outcome. 
9.1.8.   
Protocol Deviations 
Neither the Investigator nor the Sponsor is permitted to intentionally deviate from the protocol 
without proper notification to the FDA or to other relevant regulatory authorities in the form of 
a protocol amendment. Protocol deviations that occur during the study must be documented. 
The Investigator will not alter this study protocol without obtaining the written agreement from 
the sponsor. Once the study has started, amendments should be made only in exceptional 
cases. The changes then become part of the study protocol and will require re-approval of the 
Institutional Review Board (IRB/Independent Ethics Committee (IEC). 

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9.1.9.   
Disclosure of Data 
The Principal Investigator agrees by his/her participation that the results of this study may 
be used for submission to national and/or international registration and supervising 
authorities. If required, these authorities will be provided with the name of the Principal 
Investigator, their addresses, qualifications and extent of involvement. It is understood that 
the Principal Investigator is required to provide scPharmaceuticals with all study data, 
complete reports, and access to all study records.  
Data generated by this study must be available for inspection by the US FDA and other 
regulatory authorities, by scPharmaceuticals and its designees, and the IRB as appropriate. 
At a Subject’s request, medical information may be given to his or her personal physician or 
other appropriate medical personnel responsible for his or her welfare. Subject medical 
information obtained during this study is confidential and disclosure to third parties other 
than those noted above is prohibited. 
9.1.10.   
Financial Disclosure 
The US FDA Financial Disclosure by Clinical Investigators (21 CFR 54) regulations require 
Sponsors to obtain certain financial information from Investigators participating in covered 
clinical studies; each Principal Investigator and Sub-investigator is required to provide the 
required financial information and to promptly update scPharmaceuticals with any relevant 
changes to their financial information throughout the course of the clinical study and for up 
to 1 year after its completion. This rule applies to all Principal Investigators and Sub-
investigators participating in covered clinical studies to be submitted to the FDA in support of 
an application for market approval. 
9.1.11.   
Drug and Device Product Accountability 
The Investigator or designee (i.e., pharmacist) is responsible for ensuring adequate 
accountability of all used and unused study product. This includes acknowledgment of receipt 
of each shipment of study product (quantity and condition) and Subject dispensing records 
and returned study product. Dispensing records will document quantities received and 
quantities dispensed to Subjects, including lot number, date dispensed, Subject identifier 
number, Subject initials, and the initials of the person dispensing the medication. All used 
study product will be returned from the subject to the site for accountability as well and should 
be documented as the dispensation is. 
At the end of the study, following final product reconciliation by the monitor, the Sponsor will 
instruct the study site how to handle the handling of all used and unused study product and 
materials.  
9.1.12.   
Inspections 
The Investigator will provide access to source documents and all study records for this trial to 
appropriately qualified personnel from scPharmaceuticals or its representatives, and to 
regulatory authority inspectors. 
 

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9.2.   Sponsor Responsibilities 
9.2.1.   
Study Materials and Instructions 
It is the Sponsor’s responsibility to ensure that the Investigator is provided with the documents 
and other study materials necessary to conduct the study. Examples of those materials 
include, but are not limited to protocol, Investigator’s Brochure, study product, CRF, logs, etc.  
The Sponsor or designee will also provide training and oversight through site and medical 
monitoring. 
9.2.2.   
Protocol Modifications 
Protocol modifications, except those intended to reduce immediate risk to study Subjects, will 
be made by Sponsor-initiated amendment. IRB approval must be obtained before changes 
can be implemented. 
9.3.   Joint Investigator/Sponsor Responsibilities 
9.3.1.   
Access to Information for Monitoring 
In accordance with International Conference on Harmonization Good Clinical Practice (ICH-
GCP) guidelines, the study monitor must have direct access to the Investigator’s source 
documentation in order to verify the data recorded in the CRFs for consistency. 
The monitor is responsible for routine review of the CRFs at regular intervals throughout the 
study, to verify adherence to the protocol, and the completeness, consistency and accuracy 
of the data being entered. The monitor should have access to any Subject records needed to 
verify the entries on the CRFs. The Investigator agrees to cooperate with the monitor to ensure 
that any problems detected during these monitoring visits are resolved. 
9.3.2.   
Study Discontinuation 
Both the Sponsor and the Investigator reserve the right to terminate the study at any time.  
Should this be necessary, both parties will arrange discontinuation procedures and notify the 
appropriate regulatory authority(ies), IRBs and IECs. In terminating the study, the Sponsor 
and the Investigator will assure that adequate consideration is given to the protection of the 
Subjects’ interests. 

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10.   REFERENCES 
Agarwal, S. K., Wruck, L., Quibrera, M., Matsushita, K., Loehr, L. R., Chang, P. P., . . . 
Coresh, J. (2016). Temporal Trends in Hospitalization for Acute Decompensated Heart 
Failure in the United States, 1998-2011. Am J Epidemiol, 183(5), 462-470. 
doi:10.1093/aje/kwv455 
Ambrosy, A. P., Pang, P. S., Khan, S., Konstam, M. A., Fonarow, G. C., Traver, B., . . . 
Gheorghiade, M. (2013). Clinical course and predictive value of congestion during 
hospitalization in patients admitted for worsening signs and symptoms of heart failure with 
reduced ejection fraction: findings from the EVEREST trial. Eur Heart J, 34(11), 835-843. 
doi:10.1093/eurheartj/ehs444 
Benjamin, E. J., Virani, S. S., Callaway, C. W., Chamberlain, A. M., Chang, A. R., Cheng, S., 
. . . Muntner, P. (2018). Heart Disease and Stroke Statistics-2018 Update: A Report From 
the American Heart Association. Circulation, 137(12), e67-e492. 
doi:10.1161/cir.0000000000000558 
Costanzo, M. R., Johannes, R. S., Pine, M., Gupta, V., Saltzberg, M., Hay, J., . . . Fonarow, 
G. C. (2007). The safety of intravenous diuretics alone versus diuretics plus parenteral 
vasoactive therapies in hospitalized patients with acutely decompensated heart failure: a 
propensity score and instrumental variable analysis using the Acutely Decompensated Heart 
Failure National Registry (ADHERE) database. Am Heart J, 154(2), 267-277. 
doi:10.1016/j.ahj.2007.04.033 
Ellison, D. H., & Felker, G. M. (2017). Diuretic Treatment in Heart Failure. New England 
Journal of Medicine, 377(20), 1964-1975. doi:10.1056/NEJMra1703100 
Fonarow, G. C., Adams, K. F., Jr., Abraham, W. T., Yancy, C. W., & Boscardin, W. J. 
(2005). Risk stratification for in-hospital mortality in acutely decompensated heart failure: 
classification and regression tree analysis. Jama, 293(5), 572-580. 
doi:10.1001/jama.293.5.572 
Greene, S. J., Mentz, R. J., & Felker, G. M. (2018). Outpatient Worsening Heart Failure as a 
Target for Therapy: A Review. JAMA Cardiol, 3(3), 252-
259.doi:10.1001/jamacardio.2017.5250 
Mullens, W., Damman, K., Harjola, V. P., Mebazaa, A., Brunner-La Rocca, H. P., Martens, 
P., . . . Coats, A. J. (2019). The use of diuretics in heart failure with congestion - a position 
statement from the Heart Failure Association of the European Society of Cardiology. Eur J 
Heart Fail. doi:10.1002/ejhf.1369 
Neuenschwander, J. F., 2nd, & Baliga, R. R. (2007). Acute decompensated heart failure. 
Crit Care Clin, 23(4), 737-758, vi. doi:10.1016/j.ccc.2007.08.003 
Schiff, G. D., Fung, S., Speroff, T., & McNutt, R. A. (2003). Decompensated heart failure: 
symptoms, patterns of onset, and contributing factors. Am J Med, 114(8), 625-630. 
Sica, D. A., Muntendam, P., Myers, R. L., Ter Maaten, J. M., Sale, M. E., de Boer, R. A., & 
Pitt, B. (2018). Subcutaneous Furosemide in Heart Failure: Pharmacokinetic Characteristics 
of a Newly Buffered Solution. JACC Basic Transl Sci, 3(1), 25-34. 
doi:10.1016/j.jacbts.2017.10.001 
Vasko, M. R., Cartwright, D. B., Knochel, J. P., Nixon, J. V., & Brater, D. C. (1985). 
Furosemide absorption altered in decompensated congestive heart failure. Ann Intern Med, 
102(3), 314-318. 

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Yancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E., Jr., Drazner, M. H., . . . 
Wilkoff, B. L. (2013). 2013 ACCF/AHA guideline for the management of heart failure: a 
report of the American College of Cardiology Foundation/American Heart Association Task 
Force on Practice Guidelines. J Am Coll Cardiol, 62(16), e147-239. 
doi:10.1016/j.jacc.2013.05.019 
 
 
 
 
 
 
 
 

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11.   
APPENDICES 
11.1.   Appendix 1. Time and Events Schedule 
 
 
Screening and Treatment Phase 
Follow
-Up 
Phase 
DAY 0 
(Clinic) 
DAY 1 
(Clinic) 
DAY 2 
(Phone)5 
DAY 3* 
(Clinic) 
DAY 4 
(Phone) 
DAY 5 
(Phone) 
DAY 6 
(Phone) 
DAY 7 
(Clinic) 
Day 
 17 + 3 
(Phone) 
Unscheduled 
Clinic Visit7 
Unscheduled 
Phone Visit8 
DAY  
30 + 5 
(Clinic) 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Confirmation of Eligibility 
X 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical History & 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
Limited Physical Exam1 
including NYHA Class  
X 
X 
 
X 
 
 
 
X 
 
X 
 
X 
Composite Congestion Score 
X 
X 
 
X 
 
 
 
X 
 
X 
 
X 
 5-Point Current Dyspnea 
Score 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
7-Point Dyspnea Score 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vital Signs (RR, BP, HR), 
Weight + Height (Day 0 only)2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Clinical Laboratory3 
X 
X 
 
X 
 
 
 
X 
 
X 
 
X 
Urine Pregnancy Test4 
X 
 
 
 
 
 
 
 
 
 
 
 
NT-proBNP3 
X 
 
 
X 
 
 
 
X 
 
X 
 
X 
KCCQ-12 
X 
 
 
 
 
 
 
X 
 
 
 
X 
Patient Global Assessment 
VAS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
Device/Product Training 
X 
 
 
 
 
 
 
 
 
 
 
 
6MWT 
X 
X 
 
 
 
 
 
X 
 
 
 
X 
ReDS Measurement6 
X 
X 
 
X 
 
 
 
X 
 
X 
 
X 
Device/Product 
Administration7 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Device/Product Accountability 
X 
X 
 
X 
 
 
 
X 
 
X 
 
X 
Subject Diary9 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Schedule Next Study Visit 
X 
X 
 
X 
 
 
 
X 
X 
(If Necessary) 
X 
(If Necessary) 
X 
(If Necessary) 
 

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* If Day 3 falls on a Saturday or Sunday, subjects may be seen in the clinic and have Day 3 assessments completed on either Day 2 (Friday, if Day 3 falls on Saturday) or Day 4 
(Monday, if Day 3 falls on Sunday).  On Day 3 the subject will have a phone call visit. 
1Limited PE includes minimally evaluation of the skin of abdominal area, lungs/chest, heart, abdomen and periphery. 
2Vital signs include respiratory rate (RR), blood pressure (BP) and heart rate (HR) and will be obtained at clinic visits. BP and HR will be obtained with phone assessments. Weight, BP 
and HR should be obtained at home each day in the morning after Day 0, even on clinic visit days. Height recorded Day 0 only. 
3Clinical Labs are done locally and include BUN, Cr, Na+, K+, Cl, C02, and Mg; Day 0 NT-proBNP will be done locally to determine eligibility and 2nd sample sent to centralized lab for 
subjects who qualify. NT-proBNP drawn Day 3, Day 7 and Day 30 will be done at centralized lab. 
4Urine pregnancy test on females of childbearing potential. 
5Scheduled Phone Calls will have a written script to guide the site staff on what questions to ask the Subject. 
6Remote Dielectric Sensing (ReDS) System for % lung fluid measurement. 
 7If modifications are made to the diuretic regimen after Subjects’ are transitioned to their oral maintenance diuretic regimen, including additional doses of Furoscix for the treatment 
group or oral diuretics for the treatment as usual control group, the Subject will have follow-up assessments and timing of those assessments based on the investigator’s clinical 
judgement and document those under Unscheduled Visit (clinic or phone) column. Unscheduled clinic and phone visits can be conducted as needed. 
8If Subject receives unscheduled at-home phone call, the staff should perform assessments in the Unscheduled Phone Visit column. 
9Device issues should be recorded by the subject in the comments/issues section of the Subject Diary.  For each device issue recorded by the subject, a Device Issue Intake Form 
should be completed and submitted to the sponsor by the study staff.   
 
 

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11.2.   Appendix 2. Patient Global Assessment Visual Analog Scale (EQ-VAS) 
 
 
 
 

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11.3.   Appendix 3. Kansas City Cardiomyopathy Questionnaire – 12 
 
 
 

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11.4.   Appendix 4: Composite Congestion Score 
 
Source: Ambrosy et al. (2013) 
 
 
 
 
 
 

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11.5.   Appendix 5: Current Dyspnea Status - 5-Point Likert Scale 
 
 
 
 
 
CURRENT DYSPNEA STATUS 
 
 
How much difficulty are you having in breathing now? 
       not  
    
  mildly  
 
    
moderately      
   
severely    
 very severely 
short of breath      short of breath  
short of breath         short of breath 
short of breath 
        □  
  □  
        □  
       □              □ 

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11.6.   Appendix 6: Dyspnea Status  -  7-Point Likert Scale 
 
 
 
 
 

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11.7.   Appendix 7: Instructions for study staff administering Current Dyspnea 
Status Questionnaire (5-Point Likert Scale) and Dyspnea 
Status Questionnaire (7-Point Likert Scale)  
 
 
Please administer the Current Dyspnea Status Questionnaire (5-point Likert scale) first.  
Make the following statement to the Subject:  
“You have been provided a 5-point questionnaire about how you feel”.  
“I want you to think about the last day and how limited you have been in doing the 
tasks you normally do; for example:  going to the bathroom, eating, moving from the 
bed to a chair, walking, etc.”  
Then ask the Subject to look at the Current Dyspnea Status Questionnaire (5-point Likert 
scale) and say “please indicate the box that reflects the shortness of breath you have 
felt over the last day.”   
 
 
After the Current Dyspnea Status Questionnaire (5-point Likert scale) is completed say  
“Again, I want you to think about the last day and how limited you have been in doing 
the tasks you normally; do for example:  going to the bathroom, eating, moving from 
the bed to a chair, walking, etc.  Now, mark down how limited you have felt during this 
recent time frame, compared with how you felt before you started in the study.”  
Then ask the Subject to look at the Patient-Assessed Dyspnea Status Questionnaire (7-
point Likert scale) and say “please indicate the box that reflects how your breathing is 
now compared to before starting in the study.”