RecruitingNANCT07413198

A Novel, Group-mediated Exercise Intervention With Remote Activity Monitoring in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

Sponsor: Wake Forest University Health Sciences

Trial Details

ConditionHeart Failure With Preserved Ejection Fraction
Interventionmulti-domain behavioral, coaching, and exercise protocol
PhaseNA
StatusRecruiting
Participants14
Est. Completion1 Mar 2027
Last Updated26 May 2026

Primary Outcome

Exercise self-efficacy scales Scores; Exercise self-efficacy scales Scores; Exercise self-efficacy scales Scores; Exercise Benefits/Barriers Scale Score; Exercise Benefits/Barriers Scale Score; Exercise Benefits/Barriers Scale Score; Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores; Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores; Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores; Number of daily steps by accelerometer; Number of daily steps by accelerometer; Number of daily steps by accelerometer; 6-minute walk distance; 6-minute walk distance; 6-minute walk distance; The Short Physical Performance Battery (SPPB) Score; The Short Physical Performance Battery (SPPB) Score; The Short Physical Performance Battery (SPPB) Score; Grip strength; Grip strength; Grip strength; Cardiopulmonary Exercise Testing (CPET); Cardiopulmonary Exercise Testing (CPET)

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * Diagnosis of heart failure with signs and symptoms of heart failure and at least one of the following: Evidence of increased LV filling pressures at rest, exercise, or other provocations / Prior HF hospitalization / Elevated heart Failure with Preserved Ejection Fraction (H2FPEF) score or elevated Heart Failure Association-Pre-test, Echocardiography \& natriuretic peptide, Functional testing, Final etiology (HFA-PEFF) score * Left ventricular ejection fraction ≥ 50% * New York Heart Association (NYHA) functional class II-IV * Age ≥ 55 years old Exclusion Criteria: * Significant change in cardiac medication or heart failure (HF) symptoms within 3 weeks prior to enrollment * Hospitalization or urgent care visit for HF within 4 weeks prior to enrollment * Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major Cardiac Vascular (CV) surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days prior to enrolment * Uncontrolled hypertension * Recent or debilitating stroke * Severe pulmonary disease including chronic obstructive pulmonary disease (COPD) * Hemoglobin (Hgb) \< 9.5 g/dL males and \< 9 g/dL females within 30 days prior to enrollment * Patients with a history of heart transplant or Left Ventricular Assist Device (LVAD), currently on the transplant list * Significant, unrepaired cardiac valvular disease * A non-cardiac medical condition with an estimated life expectancy of \< 12 months * Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis) * Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter * A treadmill exercise test revealing: ischemia; chest pain or leg claudication; exercise Systolic Blood Pressure \> 240 mmHg, Diastolic Blood Pressure \> 110 mmHg; unstable hemodynamics or rhythm; or unwilling or unable to complete adequate exercise test * Already engaging in regular moderate to vigorous exercise conditioning defined as \>30 minutes per day, ≥twice per week consistently during the previous 6 weeks * Any condition that in the judgement of the investigator precludes participation in study or study procedures such as significant dementia, mobility impairment, uncontrolled psychiatric disease, etc. * Inability to meet the expectations of the intervention (i.e., excessive distance from facility, work conflict with intervention)

Trial Sites

Countries

United States
View Registry Entry

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