An Intervention to Promote Exercise in Adults With Heart Failure With Preserved Ejection Fraction
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Sponsor: University of Nebraska

HEART CAMP CONNECT: A FEASIBILITY STUDY 
NCT05985395  
26 DEC 2023 

 
HEART Camp Connect: A Feasibility Study 
Protocol Number: 0914-21-FB 
National Clinical Trial (NCT) Identified Number: NCT05985395 
Principal Investigator: Windy Alonso, PhD, RN 
Sponsor: GP IDeA CTR/UNMC 
Grant Title: HEART Camp Connect: A Feasibility Study 
Grant Number: NA 
Funded by: NA 
Version Number: v.1 
26 December 2023 

CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award. 

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Table of Contents 
STATEMENT OF COMPLIANCE .................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 1 
1 
PROTOCOL SUMMARY .................................................................................................................... 2 
1.1 
Synopsis ................................................................................................................................... 2 
1.2 
Schema .................................................................................................................................... 2 
1.3 
Schedule of Activities ............................................................................................................... 4 
2 
INTRODUCTION ................................................................................................................................ 5 
2.1 
Study Rationale ........................................................................................................................ 5 
2.2 
Background .............................................................................................................................. 5 
2.3 
Risk/Benefit Assessment .......................................................................................................... 6 
2.3.1 
Known Potential Risks ............................................................................................ 7 
2.3.2 
Known Potential Benefits ........................................................................................ 7 
2.3.3 
Assessment of Potential Risks and Benefits .......................................................... 7 
3 
OBJECTIVES AND ENDPOINTS ...................................................................................................... 9 
4 
STUDY DESIGN ................................................................................................................................ 9 
4.1 
Overall Design .......................................................................................................................... 9 
4.2 
Scientific Rationale for Study Design ....................................................................................... 9 
4.3 
Justification for Intervention ...................................................................................................... 9 
4.4 
End-of-Study Definition ............................................................................................................ 10 
5 
STUDY POPULATION ...................................................................................................................... 10 
5.1 
Inclusion Criteria ...................................................................................................................... 10 
5.2 
Exclusion Criteria..................................................................................................................... 10 
5.3 
Lifestyle Considerations .......................................................................................................... 10 
5.4 
Screen Failures ....................................................................................................................... 11 
5.5 
Strategies for Recruitment and Retention................................................................................ 11 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) .......................................... 11 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration .................................... 11 
6.1.1 
Study Intervention or Experimental Manipulation Description ............................... 11 
6.1.2 
Administration and/or Dosing ................................................................................ 12 
6.2 
Fidelity ..................................................................................................................................... 12 
6.2.1 
Interventionist Training and Tracking..................................................................... 12 
6.3 
Measures to Minimize Bias: Randomization and Blinding ....................................................... 12 
6.4 
Study Intervention/Experimental Manipulation Adherence ...................................................... 12 
6.5 
Concomitant Therapy .............................................................................................................. 13 
6.5.1 
Rescue Therapy .................................................................................................... 13 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL ....................................... 13 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ........................................... 13 
7.2 
Participant Discontinuation/Withdrawal from the Study ........................................................... 13 
7.3 
Lost to Follow-Up ..................................................................................................................... 14 

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STUDY ASSESSMENTS AND PROCEDURES ............................................................................... 14 
8.1 
Endpoint and Other Non-Safety Assessments ........................................................................ 14 
8.2 
Safety Assessments ................................................................................................................ 14 
8.3 
Adverse Events and Serious Adverse Events ......................................................................... 14 
8.3.1 
Definition of Adverse Events ................................................................................. 14 
8.3.2 
Definition of Serious Adverse Events .................................................................... 14 
8.3.3 
Classification of an Adverse Event ........................................................................ 15 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ...................... 16 
8.3.5 
Adverse Event Reporting ....................................................................................... 17 
8.3.6 
Serious Adverse Event Reporting.......................................................................... 17 
8.3.7 
Reporting Events to Participants ........................................................................... 17 
8.3.8 
Events of Special Interest ...................................................................................... 17 
8.3.9 
Reporting of Pregnancy ......................................................................................... 17 
8.4 
Unanticipated Problems .......................................................................................................... 17 
8.4.1 
Definition of Unanticipated Problems ..................................................................... 17 
8.4.2 
Unanticipated Problems Reporting ........................................................................ 18 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................ 18 
9 
STATISTICAL CONSIDERATIONS .................................................................................................. 19 
9.1 
Statistical Hypotheses ............................................................................................................. 19 
9.2 
Sample Size Determination ..................................................................................................... 19 
9.3 
Populations for Analyses ......................................................................................................... 19 
9.4 
Statistical Analyses.................................................................................................................. 19 
9.4.1 
General Approach ................................................................................................. 19 
9.4.2 
Analysis of the Primary Endpoint(s) ....................................................................... 19 
9.4.3 
Analysis of the Secondary Endpoint(s) .................................................................. 19 
9.4.4 
Safety Analyses ..................................................................................................... 19 
9.4.5 
Baseline Descriptive Statistics ............................................................................... 19 
9.4.6 
Planned Interim Analyses ...................................................................................... 20 
9.4.7 
Sub-Group Analyses ............................................................................................. 20 
9.4.8 
Tabulation of Individual Participant Data ............................................................... 20 
9.4.9 
Exploratory Analyses ............................................................................................. 20 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............................. 20 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ....................................................... 20 
10.1.1 
Informed Consent Process .................................................................................... 20 
10.1.2 
Study Discontinuation and Closure........................................................................ 20 
10.1.3 
Confidentiality and Privacy .................................................................................... 21 
10.1.4 
Future Use of Stored Specimens and Data ........................................................... 22 
10.1.5 
Key Roles and Study Governance ........................................................................ 22 
10.1.6 
Safety Oversight .................................................................................................... 22 
10.1.7 
Clinical Monitoring ................................................................................................. 23 
10.1.8 
Quality Assurance and Quality Control .................................................................. 23 

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10.1.9 
Data Handling and Record Keeping ...................................................................... 23 
10.1.10 
Protocol Deviations ................................................................................................ 24 
10.1.11 
Publication and Data Sharing Policy ...................................................................... 24 
10.1.12 
Conflict of Interest Policy ....................................................................................... 25 
10.2 
Additional Considerations ........................................................................................................ 25 
10.3 
Abbreviations and Special Terms ............................................................................................ 25 
10.4 
Protocol Amendment History ................................................................................................... 27 
11 
REFERENCES .................................................................................................................................. 28 

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INVESTIGATOR’S SIGNATURE 
 
 
(1) [The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following: 
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). 
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
 
Signed: 
Date: 
12/26/2023 
Name: Windy Alonso 
Title: 
Assistant Professor 
 
 
Investigator Contact Information 
Affiliation: University of Nebraska Medical Center College of Nursing 
Address: 985330 Nebraska Medical Center, Omaha, NE 689198-5330 
Telephone: 402-559-8342 
Email: windy.alonso@unmc.edu 
STATEMENT OF COMPLIANCE 

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1.1 
SYNOPSIS 
1.2 
SCHEMA 
 
 
 
 
Title: 
HEART Camp Connect: A Feasibility Study 
Grant Number: 
NA 
Study Description: 
The proposed study uses a technology-facilitated, theory-based 
intervention to help patients with HFpEF start and continue an 
exercise program over time. This feasibility, pilot study will give us data 
to refine the intervention and allow us to gather preliminary data for a 
competitive application to a federal funder. 
Objectives: 
Our overall objectives for this study are to: 
(1) evaluate the feasibility of a virtual, theory based exercise training 
and coaching intervention in adults with HFpEF; and 
(2) examine the preliminary effects of this intervention on adherence to 
exercise, physical function, key inflammatory markers, and patient- 
reported outcomes. 
Endpoints: 
Primary Endpoint: 3 months 
Secondary Endpoints: 6 months 
Study Population: 
We will enroll 25 participants with heart failure with preserved ejection 
fraction 19 years of age or older from Nebraska Medicine in Omaha, 
Nebraska. 
Phase: 
Feasibility 
Description of 
Sites/Facilities Enrolling 
Participants: 
Single site study, recruiting in the U.S. only at Nebraska Medicine in 
Omaha, Nebraska 
Description of Study 
Intervention/Experimental 
Manipulation: 
Participants are randomized to enhanced usual care or a 3 month 
coaching intervention. 
Study Duration: 
24 months 
Participant Duration: 
6 months 
 
This section should include a diagram or flowchart that provides a quick “snapshot” of the study and 
ideally is limited to 1 page. Below is an example schematic that shows the level of detail needed to 
convey an overview of the study design. Revise with study-specific information and adapt the diagram to 
illustrate your study design (e.g., changing method of assignment to study group, adding study arms, 
visits, etc.). The time point(s) indicated in the schematic should correspond to the time point(s) in Section 
1.3, Schedule of Activities, e.g., Visit 1, Day 1; Visit 2, Day 14 ± 7; etc. Although the convention is to call 
contacts with participants “Visit 1, Visit 2, etc.,” participant contacts in which data will be collected 
remotely without an in-person visit should also be included in this schematic. One alternative is to use 
the term “Time 1, Time 2, etc.,” to accommodate both in-person visits and assessments conducted 
remotely. 
1 
PROTOCOL SUMMARY 

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Intervention 
N = 25 
EUC 
N = 25 
 
 
Final Assessments 
See Section 1.3, Schedule of 
Activities 
Study Flow Diagram 
 
Pre-Screening 
 
 
 
 
 
Week 0 Baseline 
 
 
 
 
Visit 2 
Week 12 
 
 
Visit 3 
Week 24 
 
 
Total N: 50 
Pre-screen potential participants by inclusion and 
exclusion criteria; Conduct informed consent process. 
Schedule Week 0 assessments 
Randomize 
Perform baseline assessments including cardiopulmonary exercise testing, 
questionnaires, blood draws (as described in Section 1.3) 
Week 12 Assessments including repeat questionnaires, blood draws (as described in 
section 1.3) 

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Pre-screening 
(Pre-consent) 
Visit 1 
Week 0 
Visit 2 
Week 12 
Visit 3 – Final 
Week 24 
EMR Review Eligibility 
X 
Informed Consent 
X 
Cardiopulmonary exercise test 
X 
Demographics 
X 
Clinical history 
X 
X 
X 
Height & Weight 
X 
X 
X 
Randomization 
X 
Coaching Intervention* 
* 
* 
* 
Adverse Events Reporting 
X 
X 
X 
Feasibility Outcome Evaluations 
Recruitment and retention 
X 
X 
X 
X 
Coach availability 
X 
X 
X 
X 
Smart device availability 
X 
X 
X 
X 
Connectivity issues 
X 
X 
X 
X 
Patient Outcome Evaluation 
Intervention Acceptability 
X 
Pain Assessment (Brief 
Pain Inventory) 
X 
X 
X 
Quality of Life 
Questionnaire 
X 
X 
X 
Cognition 
X 
X 
X 
Health Status 
X 
X 
X 
Minutes of Exercise 
X 
X 
X 
1.3 
SCHEDULE OF ACTIVITIES 

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2.1 
STUDY RATIONALE 
2.2 
BACKGROUND 
 
 
 
Despite the worldwide acknowledgment of exercise as a beneficial, non-pharmacological therapy for 
patients with heart failure (HF), many patients, particularly those with heartfailure with preserved ejection 
fraction (HFpEF), do not engage in regular exercise and are unable to sustain exercise once started in a 
program. Patients with HFpEF report difficulties finding a routine place to exercise that includes support 
and accountability delivered near their home as barriers to continued exercise. These challenges are 
exacerbated by the ongoing COVID-19 pandemic. Therefore, we propose HEART Camp Connect that builds 
on the previously efficacious HEART Camp intervention. The primary objective of this study is to establish 
the feasibility and preliminary efficacy of the HEART Camp Connect intervention in patients with heart 
failure with preserved ejection fraction. We will accomplish this objective with two aims. Aim 1 examines 
the feasibility of administering HEART Camp Connect to patients with HFpEF. Our feasibility assessment 
will focus on process (e.g. recruitment rates, retention), resources (e.g. physical capacity, staff 
availability), management (e.g. data capture and management), and science (e.g. testing psychometrics 
of tools in the HFpEF population). Aim 2 tests the preliminary effects of HEART Camp Connect compared 
to enhanced usual care on adherence to exercise, physical activity, function, inflammation, patient- 
reported outcomes, and our theory-based interventional components. Impact: Exercise benefits patients 
with HFpEF by reducing morbidity and mortality and improving symptoms and quality of life. The 
proposed study uses a technology facilitated, theory-based intervention to help patients with HFpEF start 
and continue an exercise program over time. This feasibility, pilot study will give us data to refine the 
intervention and allow us to gather preliminary data for a competitive application to a federal funder. 
 
Heart failure with preserved ejection fraction (HFpEF) is a growing public health 
concern. Over 13 million adults in the world, including 3 million in the U.S., live with severe 
activity intolerance and poor quality of life associated with HFpEF.1,2 HFpEF is difficult to 
manage, is quickly surpassing reduced ejection HF as one of the most common causes of 
hospitalization in the U.S., and is a significant driver of the $30.7 billion annual cost of HF.1 
In the last decade, improvements have been made in the treatment of reduced ejection 
fraction HF and pharmacological therapies are standardized for these patients.3 However, 
these same therapies tested in HFpEF do not show significant benefits.4SGLT2 inhibitors, 
initially developed to treat diabetes, have shown promise in recently completed clinical trials, 
but remain off-label for adults with HFpEF.5,6 Non-pharmacological interventions, such as 
exercise, show promise in improving physiologic and patient-reported outcomes, but require 
adherence to behavioral change, which remains a barrier to achieving improved health 
outcomes.7-9 This study tests the feasibility, acceptability, and preliminary effects of an intervention 
designed to promote exercise adherence in adults with HFpEF. 
Exercise is a promising, non-pharmacological strategy to improve outcomes in adults 
with HFpEF.10 Outcomes from exercise trials in HF are encouraging, with studies 
demonstrating exercise as safe and eliciting improved aerobic capacity (peak VO2) and 
quality of life.11-15However, key gaps in this evidence remain 1. Most studies to date have 
enrolled adults with HF (HFpEF and HFrEF), including our group's HEART Camp study,16 
instead of focusing exclusively on HFpEF. 2. HFpEF trials have inconsistently defined 
2 
INTRODUCTION 

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2.3 
RISK/BENEFIT ASSESSMENT 
HFpEF with ejection fractions ranging from 40 to 50% and above. The validated H2FPEF 
algorithm17 is now available to identify HFpEF which we incorporate into our 
inclusion/exclusion criteria. 3. Prior exercise interventions tested in HF were not specifically 
designed to promote adherence using theory-based components. HEART Camp Connect is 
designed to promote adherence to exercise by supporting the adoption and maintenance of 
exercise behavior. 4. Adherence is inconsistently defined across studies and often not 
objectively measured. Several studies use session attendance as a measure of adherence, 
but this does not allow for examination of dose-response effects or comparison to other 
clinically meaningful outcomes.18-20 
 
In this study, we monitor coaching session attendance and measure adherence objectively using minutes 
of moderate intensity exercise from a heart rate monitor. 5. No studies have tested interventional effects 
on inflammatory biomarkers, despite the known relationship between HFpEF and inflammation.21 This 
pilotincorporates examination of the impact of exercise on inflammatory biomarkers. 6. Cardiac 
rehabilitation is the predominate model for exercise in adults with HF, but the program is not 
specifically designed for adults with HFpEF and current Medicare guidelines do not 
reimburse attendance .22 Further, exercise is rarely sustained after program completion and 
programs are often inaccessible. This has resulted in notoriously low attendance at cardiac 
rehabilitation and subsequent poor long-term adherence to exercise.23-27 Our intervention is 
delivered virtually making exercise content accessible to participants at any time to improve 
sustainability. 
 
Adherence is the Achilles heel of exercise in HF. The 2013 ACCF/AHA Guideline for the 
Management of Heart Failure recommends exercise as a non-pharmacological therapy that 
is safe and effective for individuals with HF (Class I - Level of Evidence A).10 Yet, studies 
indicate that as many as 91% of patients with HF do not participate in regular exercise.28-30 
Therefore, promoting adherence to exercise in HF, particularly HFpEF, is a major priority for 
the National Heart Lung and Blood Institute (NHLBI) and the long-term goal of this 
proposal.31 
HFpEF and exercise in HFpEF are assigned a high priority status by the NHLBI. The 
NHLBI convened two working groups, one addressed exercise as a non-pharmacological 
treatment for HF (2015)7 and the other (2019)31 identified knowledge gaps and set priorities for HFpEF 
research in the next 10 years. The HFpEF working group urged the development 
of effective HFpEF treatment strategies and referred to HFpEF as the greatest unmet need 
in cardiovascular medicine today. The panels set several priority targets for future study, 
including: 1. to examine optimal strategies and interventions to promote exercise initiation 
and adherence; 2. to identify behavioral mechanisms to improve adherence to exercise in 
HF; and 3. examine longitudinal changes in inflammatory biomarkers to better understand 
correlates to clinical status in HFpEF.7,31 This proposal addresses these high priority areas 
by evaluating the feasibility, acceptability and preliminary efficacy of HEART Camp Connect 
in promoting adherence to exercise, and physical activity and function, inflammatory 
markers, patient-reported outcomes, and theory-based components in HFpEF. 
 

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2.3.2
KNOWN POTENTIAL BENEFITS 
2.3.3
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
 
 
The risks associated with this study include those associated with cardiopulmonary exercise 
testing, venipuncture, exercise, emotional or psychological discomfort while answering 
questionnaires, and the risk of loss of confidentiality. 
Cardiopulmonary exercise testing (CPET): 
CPET has been shown to be safe in adults with high-risk cardiovascular diseases including 
heart failure. (Skalski 2012).However, participants may experience shortness of breath, 
angina, cardiac arrhythmias, or bronchospasm during CPET. All CPET will be completed in 
the pulmonary function lab at Nebraska Medicine - Durham Outpatient Center or Oakview 
Clinic under the supervision of a physician or advanced practice provider that has been 
trained in advanced cardiac life support (ACLS). Participants will walk on a treadmill or 
pedal a stationary bike for the test. 
 
Blood draws: 
Participants are at risk for pain, discomfort or infection at the venipuncture site. 
Exercise: Exercise training may have an associated risk of cardiac arrhythmias, blood 
pressure disturbances, fatigue, muscle, and joint discomfort, and ultimately death. Exercise 
training in stable chronic HF patients has been shown to be safe in clinical trials 
and became part of the recommended Heart Failure Society of America guideline 
of evidence-based care in 2010. 
Emotional/Psychological Discomfort: 
Participants may experience fatigue, emotional or psychological discomfort when 
completing study questionnaires. 
 
Loss of Confidentiality: 
There is a risk of a loss of participant confidentiality. We have taken measures as outlined 
above to minimize this risk to the greatest extent possible. Although reasonable efforts have 
been taken, confidentiality cannot be guaranteed since research data will be transmitted 
electronically to REDCap. 
 
Participants may benefits from exercise although benefits are not guaranteed. 
 
Minimization of Risk of CPET: 
Risk of CPET is minimized with testing completed under the supervision of a physician or 
advanced practice provider trained to recognize adverse events and in initiating an ACLS 
protocol. Safeguards are in place to protect patients before and during testing. At both 
testing sites, prior to beginning the test, a technician will measure vital signs - including 
heart rate and blood pressure - to ensure normal pre-test values. Abnormal values will result 
in the test being rescheduled. During testing, the technician will stand within 2 feet of the 
patient at all times to "spot" them in case of an adverse event. All patients wear a gait belt 
during testing to support the patient if needed during an emergency. The treadmill is 
2.3.1
KNOWN POTENTIAL RISKS 

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equipped with an emergency stop button that can be pushed if needed during the test. A 
second stop button is attached to a wristband worn by the patient that would be pulled if the 
patient were to fall or stumble. The bike is powered by the patient so if the patient is in 
distress and stops pedaling, the bike stops. Patients are monitored throughout the testing 
with an EKG and frequent blood pressure readings. We will follow Nebraska Medicine policy 
in the event of an adverse event during testing. If the patient were to suffer a cardiac arrest 
during testing, the code cart is readily available and ACLS would be initiated by the 
supervising provider. Security would be notified and the hospital-based code team would be 
alerted to respond. If testing is completed at the Oakview clinic, security would notify the 
rapid response team who would respond. 
 
Minimization of Risk of Blood Draws: 
To mitigate the risk of infection or discomfort at the venipuncture site, we will attempt to 
coordinate study-related venipuncture with that needed for clinical care as much as 
possible. In addition, blood will be collected at an outpatient laboratory center at Nebraska 
Medicine by a certified phlebotomist. 
Minimization of Risk of Psychological Discomfort: 
We advise all participants that they are under no obligation to respond to our questions and 
may decline to answer or stop at any time. Should a participant experience fatigue, we will 
allow them to take a break and continue or schedule another time within the next 48 hours 
to complete remaining questionnaires. If a subject responds to the symptom questionnaires that they 
have often or always felt depressed and/or hopeless in the past 7 days the researchers will refer them to 
their Primary Care Provider and provide a list of mental health resources including the Boys 
Town Grief Hotline. If upon questioning as to whether they have any plans to hurt 
themselves, they respond with a "yes" they will be immediately escorted to the Emergency Department 
or 9-1-1 will be contacted on their behalf. 
 
Minimization of Risk of Exercise: 
All participants will have successfully completed a 
cardiopulmonary exercise test (CPET). The results from the CPET will be used to 
develop an individualized exercise prescription for each participant that will guide heart rate 
parameters during exercise. Participants will be taught to monitor the intensity of their 
exercise by using heart rate and the rating of perceived exertion from their participation in 
our study orientation. We reduce the risk of exercising at home by requiring that another 
adult be present during the exercise in the event a subject experiences an adverse event 
requiring medical attention. The other adult will be instructed to contact the provider if the 
participant experiences a non-emergent adverse event or initiate local EMS, in the event of 
an emergency. The other adult will be instructed to then follow the instructions of the 
dispatcher. A list of potential adverse events that would warrant a call to a provider or EMS 
was attached to the application and will be shared with all participants. It is important to note 
that 150 minutes of moderate-intensity exercise is recommended for these patients and 
HFpEF patients are not eligible for cardiac rehabilitation. If these patients were not 
participating in this study, they could be doing this exercise on their own without the 
guidance that results from participating in this study. 
Minimization of Risk of Loss of Confidentiality: 
To protect against possible risks to confidentiality, research data will be stored in a locked 

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3 
OBJECTIVES AND ENDPOINTS 
4 
STUDY DESIGN 
4.1 
OVERALL DESIGN 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
4.3 
JUSTIFICATION FOR INTERVENTION 
cabinet in the research office of the PI. Subjects' names and other contact information 
(phone and emails if available) will be kept in a locked file accessible only by the PI. The 
contact information is needed in order to schedule study-related activities. All records will be 
coded with study identification numbers and kept in locked files in a locked research office. 
All downloaded files from the server will be kept on the hard drive of the principal 
investigator's computer, which is password-protected, and housed in PI's research office. All 
study personnel will be CITI trained. Study personnel will be involved in meetings and 
training sessions regarding data collection procedures in which procedures to ensure 
confidentiality will be covered. 
 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
Assessment of Feasibility & 
Acceptability 
Process, resources, 
procedures, data 
management, 
fidelity, 
acceptability 
Needed to refine intervention 
for future testing 
Secondary 
Preliminary effects on 
exercise 
Minutes of 
exercise/week 
We are not statistically 
powered to test for an effect 
Tertiary/Exploratory 
Preliminary effects on 
symptoms & interventional 
strategies 
Symptoms, quality 
of life, 
interventional 
mechanisms 
Evaluate symptoms and 
intervention strategies 
 
 
Single-site feasibility randomized controlled trial/pilot study 
 
We need to test our planned strategies to support a larger trial. 
 

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4.4 
END-OF-STUDY DEFINITION 
5 
STUDY POPULATION 
5.1 
INCLUSION CRITERIA 
5.2 
EXCLUSION CRITERIA 
5.3 
LIFESTYLE CONSIDERATIONS 
Adults with heart failure are recommended exercise as part of their plan of care; however, few do and in 
large part because they do not know how to get started. Our study helps to initiate exercise and sustain 
it over time. 
 
 
The end of the study is defined as completion of the 24 week follow-up assessment shown in the Schedule 
of Activities (SoA), Section 1.3. 
 
 
 
1. Diagnosis of heart failure with an ejection fraction greater than or equal to 50 
2. Age greater than or equal to 19 years old 
3. English-speaking 
4. Echocardiogram in prior 24 months 
5. Stable pharmacologic therapy in past 30 days 
6. Score greater than or equal to 6 on the H2FPEF algorithm or hemodynamic evidence of HFpEF 
(i.e., elevated pulmonary wedge pressure) 
 
1. Life-limiting illness precluding study completion 
2. Clinical evidence of decompensated heart failure 
3. Unstable angina or marked shortness of breath on exertion at less than 2 metabolic 
equivalents 
4. Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in 
prior 6 weeks 
5. Orthopedic or neuromuscular disorders preventing aerobic exercise 
6. Cardiopulmonary exercise test results that preclude safe exercise 
7. Unwilling/unable to complete pre-randomization procedures 
8. Pregnancy 
9. Implantable cardioverter defibrillator 
 
N/A 

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5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 
STUDY INTERVENTION 
6.1.1 
STUDY INTERVENTION 
 
 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Individuals who do not meet the 
criteria for participation in this trial (screen failure) because of meeting one or more exclusion criteria that 
are likely to change over time may be rescreened. Examples include the successful treatment of a previous 
affective disorder, and the lifting of physical activity restrictions previously in place. Rescreened 
participants will be assigned the same participant number as for the initial screening. 
 
Study personnel will coordinate all recruitment and enrollment from Nebraska Medicine (NM). Inclusion/exclusion 
criteria are listed above. Potential participants will be approached in our HFpEF Optimize Clinic or in 
the Home Instead Center for Successful Aging Gerontology clinics. As a secondary 
recruitment strategy, we will use the UNMC/NM Opt-in database. Informed consent will be 
completed using the UNMC RSS e-consent portal or in-person on paper depending on the 
participant's preference by study personnel. More detail about screening, recruitment, and 
consent is provided in subsequent sections. 
 
 
No text is to be entered in this section; rather it should be included under the relevant subheadings below. 
 
The HEART Camp Connect intervention is founded in social-cognitive theory46 and the 
future-oriented motivation and self-regulation model proposed by Miller and Brickman.47 
HEART Camp Connect (n=25) includes weekly virtual coaching sessions with experienced 
coaches from Engage. For 3 weeks per month, coaches and participants meet 1-on-1 via 
videoconference to review heart rate data, exercise diaries from the prior week and initiate 
discussion related to behavioral change mechanisms. One week per month HEART Camp 
Connect participants will be assigned to a small group (1 coach:5 participants) 
exercise/observation session. During these sessions, coaches will demonstrate exercises 
and observe participants via videoconference for proper form and real-time encouragement 
in a group setting. Coaches will call any HEART Camp Connect participant that fails to 
5.4 
SCREEN FAILURES 

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6.1.2
ADMINISTRATION AND/OR DOSING 
6.2 
FIDELITY 
6.2.1
INTERVENTIONIST TRAINING AND TRACKING 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
attend their scheduled weekly coaching session for 2 consecutive weeks. Participants 
achieving a minimum of 120 minutes of moderate-intensity exercise per week on average 
weeks 1-12 will be given the option to opt-out of coaching sessions for weeks 13-16. We 
recognize that this could potentially create variation in the dose of the coaching and 
therefore, will closely monitor the minutes of coaching per participant throughout the study. 
We will also closely monitor adherence during this time. Participants that relapse (become non-adherent 
for 2 consecutive weeks) for any reason (e.g., hospitalization, loss of 
motivation) will return to weekly coaching for the remainder of the intervention. Testing 
optional coaching is part of our feasibility assessment and increases the future scalability of 
this intervention. In the sustainability period (Weeks 17-24), weekly coaching stops, and 
HEART Camp Connect participants are expected to self-regulate exercise and maintain 
adherence. 
 
The intervention is delivered by trained exercise coaches. 
 
 
We will test coach and research personnel training as part of our feasibility objective. 
 
Participants are randomized to intervention or usual care using a random number generator in a 1:1 
intervention to control fashion. Due to funding restraints we are not using blinded date collectors for this 
pilot feasibility study. 
 
Adherence to exercise is a secondary outcome. 

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6.5.1
RESCUE THERAPY 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
 
 
N/A 
 
 
If patients are unable to safely complete the CPET or if their CPET results indicate they 
exceed our thresholds for cardiorespiratory fitness, they will be immediately withdrawn from 
the study. If the patient withdraws consent, the patient will be removed from the research 
study.. 
 
When a subject discontinues from HEART Camp Connect but not from the study, remaining study 
procedures will be completed as indicated by the study protocol. If a clinically significant finding is 
identified (including, but not limited to changes from baseline) after enrollment, the investigator or 
qualified designee will determine if any change in participant management is needed. Any new clinically 
relevant finding will be reported as an adverse event (AE). 
 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study for the following reasons: 
 
• 
Significant study intervention non-compliance, unless varying compliance is an aspect of the study 
objectives 
• 
Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
• 
Any event or medical condition or situation occurs such that continued collection of follow-up 
study data would not be in the best interest of the participant or might require an additional 
treatment that would confound the interpretation of the study 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
• 
The reason for participant discontinuation or withdrawal from the study will be recorded. Subjects who 
sign the informed consent form and are randomized but do not receive the study intervention may be 
replaced. Subjects who sign the informed consent form, and are randomized and receive the study 
intervention, and subsequently withdraw, or are discontinued from the study, will not be replaced. 
6.5 
CONCOMITANT THERAPY 

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8 
STUDY ASSESSMENTS AND PROCEDURES 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
8.2 
SAFETY ASSESSMENTS 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1
DEFINITION OF ADVERSE EVENTS 
8.3.2
DEFINITION OF SERIOUS ADVERSE EVENTS 
 
 
A participant will be considered lost to follow-up if he or she fails to return for 2 scheduled visits and study 
staff are unable to contact the participant after at least 3 attempts. 
 
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 
 
• 
The site will attempt to contact the participant, reschedule the missed visit <specify time frame>, 
counsel the participant on the importance of maintaining the assigned visit schedule and ascertain 
if the participant wishes to and/or should continue in the study 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address or local equivalent methods). 
These contact attempts will be documented in the participant’s medical record or study file. 
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up 
 
 
 
Data monitoring will occur on an ongoing basis, weekly at a minimum, and in the event of 
Any adverse event the Data Safety monitor will be notified. 
 
Cardiopulmonary exercise testing is used a baseline safety evaluation. 
 
 
 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical 
occurrence associated with the use of an intervention in humans, whether or not considered intervention- 
related. 
 
 
The study will be stopped if any adverse events result in the necessity for emergency care. 
These events will be reported immediately to the IRB and closely investigated by study 
7.3 
LOST TO FOLLOW-UP 

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8.3.3
CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1
SEVERITY OF EVENT 
8.3.3.2   RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
personnel. If any death occurs as the result of exercise or within 3 hours of an exercise 
session, the study will be stopped. 
 
 
 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines will 
be used to describe severity. 
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating. Of note, the term “severe” does not necessarily equate to “serious”. 
 
 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by an appropriately-trained clinician based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below. 
 
• 
Related – The AE is known to occur with the study procedures, there is a reasonable possibility 
that the study procedures caused the AE, or there is a temporal relationship between the study 
procedures and the event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study procedures and the AE. 
• 
Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an alternate 
etiology has been established. 
OR 
 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to study procedures administration and cannot be 
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study procedures should be clinically plausible. The event must be pharmacologically or 
phenomenologically definitive. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a 
reasonable time after administration of the study procedures, is unlikely to be attributed to 

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8.3.3.3  EXPECTEDNESS 
8.3.4
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW -UP 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal. 
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study procedures administration makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study 
procedures) and in which other drugs or chemicals or underlying disease provides plausible 
explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study procedures administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician.] 
 
 
A clinician with appropriate expertise in heart failure will be responsible for determining whether an 
adverse event (AE) is expected or unexpected. An AE will be considered unexpected if the nature, severity, 
or frequency of the event is not consistent with the risk information previously described for the study 
procedures. 
 
 
[The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant presenting for medical care, or 
upon review by a study monitor. 
 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case report form 
(CRF). Information to be collected includes event description, time of onset, clinician’s assessment of 
severity, relationship to study procedures (assessed only by those with the training and authority to make 
a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study will be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE. 

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8.3.5 
ADVERSE EVENT REPORTING 
8.3.6 
SERIOUS ADVERSE EVENT REPORTING 
8.3.7 
REPORTING EVENTS TO PARTICIPANTS 
8.3.8 
EVENTS OF SPECIAL INTEREST 
8.3.9 
REPORTING OF PREGNANCY 
8.4 
UNANTICIPATED PROBLEMS 
8.4.1
DEFINITION OF UNANTICIPATED PROBLEMS 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
 
<Insert role or name> will record events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At 
each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events 
will be followed for outcome information until resolution or stabilization. 
 
 
The study will be stopped if any adverse events result in the necessity for emergency care. 
These events will be reported immediately to the IRB and closely investigated by study 
personnel. If any death occurs as the result of exercise or within 3 hours of an exercise 
session, the study will be stopped. 
 
In consultation with the PI, a trained member of the study team will be responsible for conducting an 
evaluation of a serious adverse event and shall report the results of such evaluation to the NIH and the 
reviewing Institutional Review Board (IRB) as soon as possible, but in no event later than 10 working days 
after the investigator first learns of the event. 
 
N/A 
 
N/A 
 
There are no interventions that are likely to be of risk to a fetus. Pregnancy is unlikely in our patient 
population. 
 
 

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8.4.2
UNANTICIPATED PROBLEMS REPORTING 
8.4.3
REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP). OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)- 
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized.] 
 
 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the Data Coordinating Center (DCC)/lead principal investigator (PI). The UP report will include 
the following information: 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number 
• 
A detailed description of the event, incident, experience, or outcome 
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB and to the DCC/study 
sponsor/funding agency within <insert timeline in accordance with policy> of the investigator 
becoming aware of the event 
• 
Any other UP will be reported to the IRB and to the DCC/study sponsor/funding agency within 
<insert timeline in accordance with policy> of the investigator becoming aware of the problem 
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and the Office for 
Human Research Protections (OHRP) within <insert timeline in accordance with policy> of the 
IRB’s receipt of the report of the problem from the investigator 
 
N/A 

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9.1 
STATISTICAL HYPOTHESES 
9.2 
SAMPLE SIZE DETERMINATION 
9.3 
POPULATIONS FOR ANALYSES 
9.4 
STATISTICAL ANALYSES 
9.4.1
GENERAL APPROACH 
9.4.2
ANALYSIS OF THE PRIMARY ENDPOINT(S) 
9.4.3
ANALYSIS OF THE SECONDARY ENDPOINT(S) 
9.4.4
SAFETY ANALYSES 
9.4.5 
BASELINE DESCRIPTIVE STATISTICS 
 
 
 
We do not have a separate statistical plan for this pilot study. 
 
• 
Primary Endpoint(s): Feasibility and acceptability 
 
• 
Secondary Endpoint(s): Exercise, symptoms, quality of life 
 
 
Sample size was determined on the basis of what we expect to recruit vs. a formal power calculation given 
the pilot nature of this study. 
 
We will not be completing inferential analyses. 
 
 
 
We will report descriptive statistics including counts, proportions, and means only. 
 
• 
We will describe feasibility and acceptability. 
 
 
Descriptive statistics will be calculated as appropriate. 
 
N/A 
 
 
9 
STATISTICAL CONSIDERATIONS 

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9.4.6 
PLANNED INTERIM ANALYSES 
9.4.7 
SUB-GROUP ANALYSES 
9.4.8 
TABULATION OF INDIVIDUAL PARTICIPANT DATA 
9.4.9 
EXPLORATORY ANALYSES 
10  SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT/ASSENT 
AND 
PARTICIPANTS 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
We will compare groups on baseline statistics. 
 
 
N/A 
 
N/A 
 
N/A 
 
N/A 
 
 
 
 
 
Consent forms describing in detail the study intervention, study procedures, and risks will be given to the 
participant and written documentation of informed consent will be completed prior to starting the study 
intervention. 
 
Consent will be documented in a private room or over the phone taking into account the participants’ 
preferences. 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 

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10.1.3 CONFIDENTIALITY AND PRIVACY 
by the suspending or terminating party to <study participants, investigator, funding agency, and 
regulatory authorities>. If the study is prematurely terminated or suspended, the Principal Investigator 
(PI) will promptly inform study participants, the Institutional Review Board (IRB), and sponsor/funding 
agency and will provide the reason(s) for the termination or suspension. Study participants will be 
contacted, as applicable, and be informed of changes to study visit schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance of study staff to the protocol (ie, significant protocol violations) 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, IRB, Food and Drug Administration (FDA), or other relevant 
regulatory or oversight bodies (OHRP, DSMB).] 
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 
information from the study will be released to any unauthorized third party without prior written approval 
of the sponsor/funding agency. 
All research activities will be conducted in as private a setting as possible. 
 
The study monitor, other authorized representatives of the sponsor or funding agency, representatives of 
the Institutional Review Board (IRB), regulatory agencies or representatives from companies or 
organizations supplying the product, may inspect all documents and records required to be maintained 
by the investigator, including but not limited to, medical records (office, clinic, or hospital) and pharmacy 
records for the participants in this study. The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency 
requirements. 
 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies 
It is NIH policy that the results and accomplishments of the activities that it funds should be made available 
to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 

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10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
10.1.6 SAFETY OVERSIGHT 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 
security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate. 
 
Certificate of Confidentiality 
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has 
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical 
or other human subjects research funded wholly or in part by the federal government. Recipients of NIH 
funding for human subjects research are required to protect identifiable research information from forced 
disclosure per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set forth 
in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported research covered 
by this Policy are required to establish and maintain effective internal controls (e.g., policies and 
procedures) that provide reasonable assurance that the award is managed in compliance with Federal 
statutes, regulations, and the terms and conditions of award. It is the NIH policy that investigators and 
others who have access to research records will not disclose identifying information except when the 
participant consents or in certain instances when federal, state, or local law or regulation requires 
disclosure. NIH expects investigators to inform research participants of the protections and the limits to 
protections provided by a Certificate issued by this Policy. 
 
Data collected for this study will be analyzed and stored at REDCap. After the study is completed, the de- 
identified, archived data will be transmitted to and stored at the University of Nebraska, for use by other 
researchers including those outside of the study. 
 
Provide the name and contact information of the Principal Investigator and the Medical Monitor or 
Independent Safety Monitor. Update table heading to remove non-relevant role. 
 
Principal Investigator 
Medical Monitor or 
Independent Safety Monitor 
Windy Alonso, PhD, RN 
Bunny Pozehl, PhD, APRN 
UNMC College of Nursing 
UNMC College of Nursing 
985330 Nebraska Medical Center 
985330 Nebraska Medical Center 
402-559-8342 
402-559-8413 
Windy.alonso@unmc.edu 
bpozehl@unmc.edu 
 

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10.1.7 CLINICAL MONITORING 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
10.1.9.2 STUDY RECORDS RETENTION 
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB)/Safety 
Monitoring Committee (SMC) composed of individuals with the appropriate expertise. 
 
 
 
Clinical site monitoring will be conducted to ensure that the rights and well-being of trial participants 
are protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct 
of the trial is in compliance with the currently approved protocol/amendment(s), with International 
Council on Harmonisation Good Clinical Practice (ICH GCP), and with applicable regulatory 
requirement(s). 
 
This is single site study 
 
 
Data collection will be the responsibility of the clinical trial staff at the site under the supervision of the 
site investigator. The investigator will be responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. 
 
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data. 
 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant consented/enrolled in the study. Data recorded in the electronic case 
report form (eCRF) derived from source documents will be consistent with the data recorded on the 
source documents. 
Data will be collected and managed in REDCap. 
 
 
Study documents will be retained for a minimum of 2 years after the last approval of a marketing 
application in an International Council on Harmonisation (ICH) region and until there are no pending or 
contemplated marketing applications in an ICH region or until at least 2 years have elapsed since the 

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10.1.10 
PROTOCOL DEVIATIONS 
10.1.11 
PUBLICATION AND DATA SHARING POLICY 
formal discontinuation of clinical development of the study intervention. These documents should be 
retained for a longer period, however, if required by local regulations. No records will be destroyed 
without the written consent of the sponsor/funding agency, if applicable. It is the responsibility of the 
sponsor/funding agency to inform the investigator when these documents no longer need to be retained.] 
 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the 
study site staff. As a result of deviations, corrective actions will be developed by the site and implemented 
promptly. 
These practices are consistent with ICH GCP: 
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3 
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1 
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2. 
 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within <specify number> working days of identification of the protocol deviation, or within 
<specify number> working days of the scheduled protocol-required activity. All deviations will be 
addressed in study source documents, reported to <specify NIH Institute or Center (IC)> Program Official 
and <specify Data Coordinating Center or sponsor>. Protocol deviations will be sent to the reviewing 
Institutional Review Board (IRB) per their policies. The site investigator will be responsible for knowing 
and adhering to the reviewing IRB requirements. Further details about the handling of protocol deviations 
will be included in the MOP. 
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals. Data from this study may be requested from other researchers x years after the completion of 

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10.1.12 
CONFLICT OF INTEREST POLICY 
10.2 ADDITIONAL CONSIDERATIONS 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
the primary endpoint by contacting <specify person or awardee institution, or name of data repository>. 
Considerations for ensuring confidentiality of these shared data are described in Section 10.1.3. 
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a way 
that is appropriate to their participation in the design and conduct of this trial. The study leadership in 
conjunction with the Great Plains IDeA CTR has established policies and procedures for all study group 
members to disclose all conflicts of interest and will establish a mechanism for the management of all 
reported dualities of interest. 
 
N/A 
 
 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HF 
Heart Failure 
HFpEF 
Heart Failure with Preserved Ejection Fraction 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICH 
International Council on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 

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IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH 
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 

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Version 
Date 
Description of Change 
Brief Rationale 
NA 
10.4 PROTOCOL AMENDMENT HISTORY 

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Include a list of relevant literature and citations for all publications referenced in the text of the protocol. 
Use a consistent, standard, modern format, which might be dependent upon the required format for the 
anticipated journal for publication (e.g., N Engl J Med, JAMA, etc.). The preferred format is International 
Committee of Medical Journal Editors (ICMJE). 
References 
 
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failure with preserved ejection fraction in the EMPEROR-preserved trial. Eur J Heart Fail. 2020;22(12):2383- 
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