Clinical trial NCT05528588
Conditions: Heart Failure
Sponsor: University of Texas Southwestern Medical Center
Start date: 2023-06-02; Completion date: 2024-07-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This will be a randomized, open-label pilot study of 70 patients with and without diuretic resistance who were recently admitted and discharged for acute decompensated heart failure with and oral diuretic regimen testing whether Furoscix is more effective at achieving post-discharge outpatient diuresis than standard of care. Diuretic resistance will be identified using the BAN-ADHF (BUN, creAtinine, NP-levels, Age, Diabetes and DBP, HF hospitalization, and atrial Fibrillation) score which has been integrated into the electronic health record. The score is integer-based with a score of ≥ 12 indicating diuretic resistance with high likelihood of poor outcomes. The primary outcome is diuretic efficacy as measured by volume of urine produced 8 hours after treatment and urine sodium levels (assessed hourly or per urination episode within 8 hours of treatment).

Detailed description:
Heart failure is one of the leading causes of hospitalization in the United States, contributing to over 1 million emergency department visits and nearly 1 million hospitalizations for HF annually. The estimated mean cost for HF was $11,552 in 2014, totaling an estimated $11 billion. Thus, strategies to reduce the burden of acute care use for patients with heart failure are necessary. Acute decompensation of heart failure is characterized by volume overload and is primarily treated with intravenous diuretics. However, inefficient and ineffective diuresis both during hospitalization and in the post-discharge environment predispose patients to frequent readmission and a worse prognosis. Importantly, there is heterogeneity in patient response to intravenous diuresis, with an estimated 20-50% of patients having poor response to initial IV diuretic therapy. Patients who are resistant to intravenous diuresis have increased risk of rehospitalization and mortality. Importantly, our group recently derived an integer-based risk score (BAN-ADHF score) to predict patients with low diuretic efficiency.

The investigators will screen eligible patients in the inpatient setting and schedule a research appointment within 14 days after discharge. At the research appointment, patients will be consented and undergo stratified randomization based on BAN-ADHF score (≥ 12 vs. \<=11). Within each stratum, patients will be randomized in a 1:1 ratio (intervention: control). The intervention arm (Furoscix over 5 hours at 8mg/mL) will be compared to a usual care group (home oral diuretic dose prescribed by discharge physician). Patients will be monitored for 8 hours in the Clinical Research Unit post-drug administration for clinical safety and to measure clinical response. This study will take place at the Clinical Research Unit in the Aston Building at UT Southwestern Medical Center.

Arms: arm 1: Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive Furoscix over 5 hours at 8 mg/mL. arm 2: Patients without diuretic resistance as determined by BAN-ADHF score \<= 11 will receive Furoscix over 5 hours at 8 mg/mL. arm 3: Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic. arm 4: Patients without diuretic resistance as determined by BAN-ADHF score \<= 11 will receive home dose oral diuretic
Interventions: intervention 1: Furoscix intervention 2: Diuretic Therapy
Intervention descriptions: intervention 1: 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). intervention 2: Patients will receive home dose oral furosemide or oral furosemide per standard of care.

Protocol documents:
Prot_SAP_000.pdf: 
STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
 
 
Official title: Furoscix in Heart Failure Patients with Diuretic 
Resistance 
 
NCT number: NCT05528588 
IRB Approved date: 07-22-24 


Form A 
IRB # 
STU-2022-0768 
 
STU2022-0768, Pandey, FormA-Protocol, Mod_6, 07-22-24 
1 
V2Mar2018 
PROTOCOL FORM / RESEARCH DESCRIPTION 
 
If an item does not apply to your research project, indicate that the question is "not applicable” – do not leave sections blank 
 
Click once on the highlighted entry in each box to provide your response.  Click the item number/letter or word, if hyperlinked, 
for detailed instructions for that question.  If your response requires inserting a table, picture, etc, you may need to first delete the 
box that surrounds the answer and then insert your table or other special document. 
 
 
1.  Purpose and objectives.           List the purpose and objectives: 
 
The purpose of this study is to assess the diuretic efficiency of subcutaneous furosemide (Furoscix) compared to 
oral diuretic therapy for patients post heart failure (HF) hospitalization and evaluate the impact of diuretic resistance 
as identified by the BAN-ADHF (Blood urea nitrogen, creAtinine, Natriuretic Peptide levels, Atrial fibrillation, 
Diastolic blood pressure, Hypertension and Home diuretic dose, and Heart Failure hospitalization) risk score. 
 
Key Outcomes: 
1. Post-treatment urine output over 8 hours. This will be assessed in mL per mg of treatment (Furoscix vs. oral 
diuretic). 
2. Post-treatment urine sodium. Urine sodium will be assessed hourly over 8 hours post-treatment. 
Safety Outcome Measures: 
1. Number of participants with post-intervention need for emergency department visit or hospitalization. 
The count of participants with post-intervention need for emergency department visit or hospitalization for 
worsening heart failure is assessed. 
 
Goals: Successful completion of this project will establish proof of concept that Furoscix provides more effective 
post-hospitalization diuresis than the traditional oral dose in a diuretic resistance patient population. This study will 
provide pilot data to guide the design of larger studies involving a diuretic-resistant heart failure population. 
 
 
 
2.  Background. 
• 
Describe past experimental and/or clinical findings leading to the formulation of your study.   
• 
For research involving investigational drugs, describe the previously conducted animal and human studies.   
• 
For research that involves FDA approved drugs or devices, describe the FDA approved uses of this drug/device in 
relation to your protocol.   
• 
Attach a copy of the approved labeling as a product package insert or from the Physician’s Desk Reference.   
You may reference sponsor’s full protocol or grant application (section number and/or title) or if none, ensure background 
includes references. 
 
Please respond to all components of this item, or clearly indicate which components are not applicable. 
 
a. 
Background 


Form A 
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V2Mar2018 
Introduction  
Heart failure is one of the leading causes of hospitalization in the United States, contributing to over 1 million 
emergency department visits and nearly 1 million hospitalizations for HF annually.1 The estimated mean cost for 
HF was $11,552 in 2014, totaling an estimated $11 billion.2 Thus, strategies to reduce the burden of acute care 
use for patients with heart failure are necessary. Acute decompensation of heart failure is characterized by 
volume overload and is primarily treated with intravenous diuretics. However, inefficient and ineffective diuresis 
both during hospitalization and in the post-discharge environment predispose patients to frequent readmission 
and a worse prognosis.3 Importantly, there is heterogeneity in patient response to intravenous diuresis, with an 
estimated 20-50% of patients having poor response to initial IV diuretic therapy.3 Patients who are resistant to 
intravenous diuresis have increased risk of re-hospitalization and mortality. Importantly, our group recently 
derived an integer-based risk score (BAN-ADHF score) to predict patients with low diuretic efficiency, with the 
research winning the NHLBI Heart Failure Data Challenge.4,5  
 
As part of patient’s standard of care, they receive oral diuretics, including furosemide or torsemide, which are 
FDA approved for treating congestion and volume overload from heart failure. However, some patients are 
“resistant” to oral diuretics and have higher risk of repeat hospitalization. Therefore, purpose of this study is to 
evaluate treatment with subcutaneous furosemide (Furoscix) compared with oral diuretic therapy for patients with 
recent heart failure hospitalization either with or without diuretic resistance. 
 
Furoscix (Furosemide Injection) is FDA approved for subcutaneous administration for the treatment of congestion 
due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic 
heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization.6 The 
research team is collecting safety and efficacy data on this drug.   
 
This drug is administered via a device called the Infusor (Note: The research team is not studying the device 
component). The Infusor delivers 80 mg of Furoscix. Per Sponsor: “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 
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).”7 
 
References: 
1. 
Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain 
AM, Cheng S, Delling FN, et al. Heart Disease and Stroke Statistics-2021 Update: A Report From the 
American Heart Association. Circulation. 2021;143:e254-e743. doi: 10.1161/CIR.0000000000000950 
2. 
Jackson SL, Tong X, King RJ, Loustalot F, Hong Y, Ritchey MD. National Burden of Heart Failure Events 
in the United States, 2006 to 2014. Circ Heart Fail. 2018;11:e004873. doi: 
10.1161/CIRCHEARTFAILURE.117.004873 
3. 
Gupta R, Testani J, Collins S. Diuretic Resistance in Heart Failure. Curr Heart Fail Rep. 2019;16:57-66. 
doi: 10.1007/s11897-019-0424-1 
4. 
Chaikijurajai T, Segar MW, Pandey A, Tang WHW. Validation Of The BAN-ADHF Risk Score And Risk 
Of Long-term Mortality In Patients With Acute Decompensated Heart Failure. Journal of Cardiac Failure. 
2022;28:S36-S37. doi: https://doi.org/10.1016/j.cardfail.2022.03.098 
5. 
Parsa S, Segar M, Butler J, Willett D, Tang WHW, Pandey A. PREDICTION OF DIURETIC 
RESISTANCE IN PATIENTS WITH CHRONIC STABLE HEART FAILURE: THE BAN-ADHF RISK 
SCORE. Journal of the American College of Cardiology. 2022;79:293-293. doi: doi:10.1016/S0735-
1097(22)01284-0 
6.        Furoscix (furosemide injection). Burlington, MA. scPharmaceuticals, 2022.  
7.        scPharmaceuticals, 2022. Confidential document.  
 
 
 


Form A 
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V2Mar2018 
b. 
Current practice 
After discharge, current practice is to transition patients back to a home oral diuretic regimen in hopes that this 
will provide sufficient diuresis to prevent re-hospitalization. 
 
 
3.  Study Design.  
Describe the study design (e.g., single/double blind, parallel, crossover, etc.)  Consider inserting a scheme to visually present the 
study design. 
 
This will be a randomized, open-label pilot study of 70 patients with and without diuretic resistance who were 
recently admitted and discharged for acute decompensated heart failure with an oral diuretic regimen testing 
whether Furoscix is more effective at achieving post-discharge outpatient diuresis than standard of care. 
Schema: 
 
Visual description of the BAN-ADHF Score 
 
 
 
Study 
Population
≥12 BAN-
ADHF (n=46)
Furoscix
(n=23)
Control 
(n=23)
<12 BAN-
ADHF (n=24)
Furoscix
(n=12)
Control 
(n=12)


Form A 
IRB # 
STU-2022-0768 
 
STU2022-0768, Pandey, FormA-Protocol, Mod_6, 07-22-24 
4 
V2Mar2018 
 
4.  Research Plan / Description of the Research Methods:   
4.a.  Provide a comprehensive narrative describing the research methods.   
     1) Provide the order in which tests/procedures will be performed,  
     2) Provide the setting for these events and a description of the methods used to protect privacy during the study.   
     3) Provide the plan for data analysis (include as applicable the sample size calculation) 
 
Please respond to all components of this item, or clearly indicate which components are not applicable. 
 
Inclusion and Exclusion Criteria:  
 
Eligibility criteria are shown in the following table:  
 
Inclusion Criteria 
Exclusion Criteria 
• 
English speaking patients discharged after 
ward hospitalization for acute 
decompensated heart failure 
• 
Able to be screened and enrolled within 14 
days of discharge 
• 
Recent echocardiogram (6 months or less) 
• 
Discharged with diuretic therapy 
 
• 
Chronic kidney disease stage 5 (GFR<20) or End 
Stage Kidney Disease 
• 
Systolic blood pressure <100 
• 
ICU hospitalization within 3 months 
• 
Inotrope use within last 3 months 
• 
Home inotropes 
• 
Electrolyte abnormalities on discharge 
• 
Inadequate data for BAN-ADHF score 
• 
Pregnant 
• 
Prior heart transplantation or left ventricular assist 
device 
• 
Low-output heart failure 
• 
Concurrent use of non-loop diuretic 
• 
Advanced liver disease 
• 
Severe malnutrition 
• 
Skin/Soft tissue condition precluding Furoscix 
• 
Inability to collect urine 
• 
Non-English-speaking patients 
 
 
Intervention, Setting, and Design: We are recruiting patients from UTSW and Parkland. All of the research 
procedures in this study will take place at the Clinical Research Unit in the Aston Building at UT Southwestern 
Medical Center. This will be a randomized, open-label pilot study of 70 patients with and without diuretic resistance 
who were recently admitted and discharged for acute decompensated heart failure with an oral diuretic regimen 
testing whether Furoscix is more effective at achieving post-discharge outpatient diuresis than oral diuretics. Diuretic 
resistance will be identified using the BAN-ADHF (Blood urea nitrogen, creAtinine, Natriuretic Peptide levels, Atrial 
fibrillation, Diastolic blood pressure, Hypertension and Home diuretic dose, and Heart Failure hospitalization) score 
which has been integrated into the electronic health record. The score is integer-based with a score of ≥ 12 
indicating diuretic resistance with high likelihood of poor outcomes.  
 
Screening: 
• 
We are requesting a partial HIPAA waiver to review electronic health records and confirm their eligibility in 
the study. Pre-screening will occur through the electronic health record to evaluate for inclusion and 
exclusion criteria and to assess if women of child-bearing potential have a pregnancy test to confirm they 
are not pregnant. Lab testing will be reviewed. These include review of urine drug screen, alcohol screen (if 
clinically indicated), NT-proBNP, creatinine clearance.  
• 
BAN-ADHF score will be calculated. 


Form A 
IRB # 
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• 
After patients are screened, patients will be approached for potential participation. If patients are interested, 
they will be scheduled for an in-person randomization visit optimally within 1-7 days of hospital discharge, 
although patients will be eligible up to 14 days after discharge.  
• 
At the research appointment, patients will be asked if they are interested in voluntarily participating in this 
study. 
 
Research Visit: 
 
Pre-Randomization: 
• 
Confirm eligibility  
• 
Obtain informed consent  
• 
Physical exam including vital signs assessment.  
• 
Prior and concomitant medication assessment.  
 
Randomization:  
If patients still meet all eligibility criteria and sign informed consent, they will undergo stratified randomization based 
on BAN-ADHF score (≥12 vs. <12). Within each stratum, patients will be randomized in a 1:1 ratio (intervention: 
control) during the research visit. Patients will be informed via telephone prior to visit to not take home oral dose of 
diuretic on the day of the visit and will be instructed to hold any caffeine products such as coffee or any other drugs 
that could increase urine output on the day of the visit.   
• 
Intervention: Furoscix – administration of subcutaneous furosemide (Furoscix) during study visit. It will be 
administered using the Furoscix Infusor. Per information from the Sponsor, “The Infusor is placed on the 
patient’s abdomen for subcutaneous infusion. Furoscix is delivered subcutaneously through a small, 27-
gauge, 6 mm needle. The Infusor is preprogramed 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.”7 
• 
Control: Oral Diuretic - administration of oral diuretic during study visit. Patients will bring their home 
prescription of oral diuretic and will take the oral formulation while in the visit. If the patient did not bring 
their home dose, an equivalent oral dose will be provided from the UT Southwestern Investigational Drug 
Service.  
 
The intervention arm (Furoscix over 5 hours at 8 mg/mL) will be compared to a usual care group (home oral diuretic 
dose prescribed by discharge physician). Patients will be monitored for 8 hours in the Clinical Research Unit post-
drug administration for clinical safety and to measure clinical response.  
 
Other research procedures:  
• 
Patients will be instructed to void immediately before dosing (pre-dose urine) and this sample will be 
discarded. After medication administration, urine from spontaneous voids during post-dose phases will be 
collected and recorded. Urine sodium measurements will be obtained at hourly intervals. Urine from each 
collection period must be refrigerated until the end of the collection period. Total volume of urine produced 
will be assessed over 8 hours post-study drug administration. 5 mL of each hourly urine sample will be sent 
for a urine sodium lab test in a yellow round bottom tube.  
• 
Collect approximately 10 mL of blood for a blood test to check patient’s electrolytes. This will be done at the 
end of the research visit.  
• 
Call participants in 7 days after their research visit to assess if patient has had a presentation to urgent care, 
emergency department, or is re-hospitalized for acute exacerbation in heart failure.  
 
Compensation:  
To account for a full day of research monitoring, patients will be compensated $250 for their participation in the 
study with the UTSW ClinCard.  
 
Data Safety and Monitoring:  
Patient safety will be tracked over the study. For any adverse events (AE) that occur during their participation in the 
study, medical care will be provided and patients will be followed until resolution. See Form D for more details.  


Form A 
IRB # 
STU-2022-0768 
 
STU2022-0768, Pandey, FormA-Protocol, Mod_6, 07-22-24 
6 
V2Mar2018 
 
Privacy and Confidentiality:  
To protect patient’s privacy and confidentiality, we will ensure the consent process takes place in a private area and 
conduct research in secure areas where others will not have access to their PHI. All PHI collected during the study 
will be coded with a Subject ID using a randomized code. The key to the code will be kept on a password database 
in the research coordinator's locked office. Only authorized personnel listed on Form B will have access to the data. 
Any hard copy documents such as the signed consent form will be kept in the research coordinator’s locked office.  
 
Statistical Analysis:  
This study will assess the primary outcomes of greater diuretic efficiency as measured by total urine output and 
urine sodium. As the Furoscix group will receive 80 mg of subcutaneous furosemide and the control group will take 
a home dose of oral diuretic, urine output will be normalized per mg of treatment administered. Differences in total 
urine produced will be compared between Furoscix versus oral diuretic groups. The urine sodium will be assessed 
hourly, and will be compared across the two groups.   
 
As this study is a preliminary pilot study to assess the effect of Furoscix on diuretic efficacy, we have chosen a 
convenience sample of 70 patients to allow for a comparison between patients who receive Furoscix and those who 
do not receive Furoscix. The results of this trial will serve as a precursor for a larger, multicenter trial of Furoscix in 
patients with diuretic resistance.  
 
 
4.b.  List of the study intervention(s) being tested or evaluated under this protocol 
 
N/A -  this study does not test or evaluate an intervention.    Skip to item 4.d. 
# 
Study intervention(s) being tested or evaluated under the protocol 
 
 
 
Add or delete rows as needed 
 
Affiliate 
 
Place a check next to 
institution(s) where 
the  
intervention will be 
performed 
Local Standard 
Practice?  
Indicate whether the 
intervention is 
considered 
acceptable practice 
locally for applicable 
institutions 
1 
Furoscix (Furosemide subcutaneous) 
☒ UTSW 
☐ Yes 
☐ PHHS 
☐ Yes 
☐CMC 
☐ Yes 
☐THR 
☐ Yes 
☐TSRH 
☐ Yes 
☐ Other: _____ 
☐ Yes 
2 
Insert study intervention 2 here 
☐ UTSW 
☐ Yes 
☐ PHHS 
☐ Yes 
☐CMC 
☐ Yes 
☐THR 
☐ Yes 
☐TSRH 
☐ Yes 
☐ Other: _____ 
☐ Yes 
 


Form A 
IRB # 
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V2Mar2018 
 
4.c.  Risk:Benefit Analysis of study interventions being tested or evaluated under this protocol 
For each study intervention identified in section 6b above, complete a risk:benefit analysis table. 
 
(Two tables are provided, copy & paste additional tables as needed or delete both tables if this study does not test an 
intervention) 
 
 
4.c. 
Study Intervention #1 
Furoscix (Furosemide subcutaneous) 
List each group exposed to this 
intervention on a separate line. 
(e.g., experimental, control, Arm A, Arm B, 
etc) 
Or state All Groups/Subjects 
For each group, list the benefits of this intervention.  (Benefits can be directly from 
the intervention or from a monitoring procedure likely to contribute to the subject’s 
well being).  If there are no benefits, state “none”. 
Intervention arm (Furoscix) 
Participants will not personally benefit from this study. Their participation may 
provide data that will help prevention of future heart failure hospitalizations. 
 
 
 
If you are requesting a Waiver of Informed Consent, complete the table below. 
 
If you have a consent form, list the reasonably foreseeable risks in the consent form (and do not complete this section).   
 
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious). 
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms) 
Do not delete frequency.  Frequency must be estimated because it will assist you with determining which adverse events will require 
prompt reporting.   
 
Not serious 
Serious  
Likely 
These risks are expected to occur in 
more than 20 out of 100 subjects. 
• 
 
• 
 
 
Not serious 
Serious 
Less likely  
These risks are expected to occur in 5-
20 subjects or less out of 100 subjects. 
• 
 
• 
 
 
 
Serious 
Rare  
These risks are expected to occur in 
less than 5 subjects out of 100  
 
• 
 
 


Form A 
IRB # 
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V2Mar2018 
4.c. 
Study Intervention #1 
Insert name used in 4.b. 
List each group exposed to this 
intervention on a separate line. 
(e.g., experimental, control, Arm A, Arm B, 
etc) 
Or state All Groups/Subjects 
For each group, list the benefits of this intervention.  (Benefits can be directly from 
the intervention or from a monitoring procedure likely to contribute to the subject’s 
well being).  If there are no benefits, state “none”. 
 
 
 
 
If you are requesting a Waiver of Informed Consent, complete the table below. 
 
If you have a consent form, list the reasonably foreseeable risks in the consent form (and do not complete this section).   
 
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious). 
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms) 
Do not delete frequency.  Frequency must be estimated because it will assist you with determining which adverse events will require 
prompt reporting.   
 
Not serious 
Serious  
Likely 
These risks are expected to occur in 
more than 20 out of 100 subjects. 
• 
 
• 
 
 
Not serious 
Serious 
Less likely  
These risks are expected to occur in 5-
20 subjects or less out of 100 subjects. 
• 
 
• 
 
 
 
Serious 
Rare  
These risks are expected to occur in 
less than 5 subjects out of 100  
 
• 
 
 
 
 


Form A 
IRB # 
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V2Mar2018 
 
 
4.d. List ALL other research procedures or components not listed in table 4.b. 
        The combination of Tables 4b and 4d should account for all of the research 
procedures that will take place during this study. 
 
Consider grouping similar procedures under a single component (e.g., blood work, CT = safety 
assessments) 
 
 
 
# 
Research component 
• 
individual 
procedures 
 
example: 
Eligibility Assessments 
• 
History and 
physical 
• 
Questionnaire 
• 
Laboratory tests 
Add or delete rows as needed 
Column A 
Local Standard 
Practice Indicate the 
number of times each 
procedure will be 
performed as stipulated 
in the research plan that 
would be performed if 
the participant were not 
participating in the 
study. 
Column B 
Research Only  
Indicate the number of times 
each procedure will be 
performed solely for research 
purposes (meaning that the 
participant would not undergo 
the same number of 
procedures or would not 
undergo the procedure(s) at 
the same frequency if they 
were not participating in the 
study) 
Column D 
Risks 
If you are requesting a Waiver of Informed 
Consent, complete the table below. 
 
List the reasonably expected risks for each procedure 
or group of procedures under the following categories 
as appropriate: 
• Serious and likely; 
• Serious and less likely; 
• Serious and rare; 
• Not serious and likely; 
• Not serious and less likely 
1 
Screening for Eligibility in 
Medical Records 
N/A 
Multiple Times 
Breach of confidentiality; not serious and less likely 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
2 
CRU visit 
 
 
 
 
Screening Procedures 
N/A 
Once 
N/A-See risks in the consent form 
 
Urine samples  
N/A 
Multiple times 
N/A-See risks in the consent form 
 
10 mL blood draw 
 
Once  
N/A-See risks in the consent form 
3 
Post-CRU visit follow-up 
 
 
 
 
Call patient to assess whether 
they were hospitalized in 7 
days post discharge 
N/A 
Once  
N/A-See risks in the consent form 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
4 
Insert component 4 here 
 
 
 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
 
Insert procedure here 
 
 
 
 
 
 
5.  Safety Precautions.  (Describe safeguards to address the serious risks listed above.) 
a.  Describe the procedures for protecting against or minimizing any potential risks for each of the more than minimal risk 
research procedures listed above. 
Risks and side effects related to Furoscix include those which are: 
 
Likely, some may be Serious 
In 100 people, approximately 21-100 may have: 
• 
Dehydration 
• 
Electrolyte depletion, including low potassium (hypokalemia), low sodium (hyponatremia), low 
magnesium (hypomagnesemia), low calcium (hypocalcemia).  
• 
Dry mouth 
• 
Thirst 


Form A 
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• 
Weakness 
• 
Muscle pains or cramps 
• 
Low blood pressure 
• 
High heart rate 
• 
Arrythmia 
• 
Nausea or vomiting 
 
Less Likely, some may be Serious 
In 100 people, approximately 2-20 may have: 
• 
Deterioration in kidney function 
• 
Increased uric acid and gout 
• 
Urine bladder spasm 
• 
Transient injection site pain 
• 
Fever 
• 
Restlessness 
 
Rare and Serious 
In 100 people, approximately 1 or less may have: 
• 
Exacerbation of systemic lupus erythematosus 
• 
Allergy to furosemide/Systemic hypersensitivity reactions 
• 
Liver or kidney damage 
• 
Tinnitus and hearing loss 
• 
Aplastic anemia, thrombocytopenia, agranulocytosis 
• 
Skin hypersensitivity reactions 
 
Risks and side effects related to Oral Diuretic Therapy: 
Likely, some may be Serious 
In 100 people, approximately 21-100 may have: 
• 
Dehydration 
• 
Electrolyte depletion, including low potassium (hypokalemia), low sodium (hyponatremia), low 
magnesium (hypomagnesemia), low calcium (hypocalcemia).  
• 
Dry mouth 
• 
Thirst 
• 
Weakness 
• 
Muscle pains or cramps 
• 
Low blood pressure 
• 
High heart rate 
• 
Dizziness 
Less Likely, some may be Serious 
In 100 people, approximately 2-20 may have: 
• 
Deterioration in kidney function or an acute kidney injury 
• 
Increased uric acid and gout 
• 
Urine bladder spasm 
Rare and Serious 
In 100 people, approximately 1 or less may have: 
• 
Exacerbation of systemic lupus erythematosus 
• 
Allergy to furosemide or torsemide/Systemic hypersensitivity reactions 
• 
Liver or kidney damage 
• 
Tinnitus and hearing loss 
• 
Aplastic anemia (bone marrow failure), thrombocytopenia (low blood platelet count), 
agranulocytosis (low white blood cell count) 
• 
Skin hypersensitivity reactions such as skin rash  


Form A 
IRB # 
STU-2022-0768 
 
STU2022-0768, Pandey, FormA-Protocol, Mod_6, 07-22-24 
11 
V2Mar2018 
 
Furoscix is a specific subcutaneous formulation of furosemide. Patients are required to be taking home diuretics 
as eligibility criteria; therefore we anticipate very few side effects associated with the medication. Skin reactions 
may occur with administration of Furoscix, although this is a rare side effect. Patients will be monitored for 8 
hours post medication administration, with a serum potassium check performed after the study visit to ensure 
stable serum electrolytes.  
 
b.  Where appropriate, discuss provisions for ensuring necessary medical or professional intervention in the event of adverse 
events, or unanticipated problems involving subjects. 
A physician will be always available during the study visits. A research nurse will be monitoring the patient 
throughout the research visit. We will also follow up with patients over the phone in a week after their study visit.  
 
Should any AE’s occur, it will be documented and medical care will be provided. The team will follow patient’s AE 
until resolution. See Form D for more information.  
 
c.  Will the safeguards be different between/among groups?   
Yes 
No 
N/A