HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction
Recruiting · NCT05784753 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Nebraska
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by video conference will help these patients exercise, feel better, and change markers in their blood. Participants will be randomly placed in one of three groups for 18 months. All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise. The usual care group (control group) will have access to exercise videos via the medical fitness center and will not meet with a coach. The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center. The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing. All participants will take part in an exercise test and study training prior to being randomized. At four data collection time points, participants will wear an activity monitor for 7 days each, have their blood drawn, and answer questions related to heart failure and exercise. Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary.
Who can take part
Inclusion criteria
- Diagnosis of heart failure with an ejection fraction greater than or equal to 50
- Echocardiogram in prior 24 months
- Stable pharmacologic therapy in the past 30 days
- Any of the following evidence to confirm HFpEF - Score\< 6 on Heavy Hypertensive Atrial Fibrillation, Pulmonary Hypertension, Elder, Filling Pressure algorithm, invasive hemodynamic evidence of HFpEF(i.e., elevated pulmonary wedge pressure), or a confirmed clinical diagnosis of HFpEF
Exclusion criteria
- Life-limiting illness precluding study completion
- Clinical evidence of decompensated heart failure
- Unstable angina or marked shortness of breath on exertion at less than 2 metabolic equivalents
- Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in prior 6 weeks
- Orthopedic or neuromuscular disorders preventing aerobic exercise
- Cardiopulmonary exercise test results that preclude safe exercise
- Unwilling/unable to complete pre-randomization procedures
- Pregnancy
- Implantable cardioverter defibrillator
Where it is running
3 locations listed across 3 US states.
- Henry Ford Health System - Detroit, Michigan, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- University of Virginia - Charlottesville, Virginia, United States