Group exercise with remote activity monitoring for older adults with heart failure

Trial details

Who runs it

Wake Forest University Health Sciences

Trial code

NCT07413198

Record updated

26 May 2026

Original description

Heart failure with preserved ejection fraction (HFpEF) represents a major public health burden that is both growing rapidly and has few effective therapies. Supervised exercise training (SET) is one of the few effective therapies for older patients with HFpEF, but is currently constrained by cost, resource limitations, and sub-optimal short and long-term clinical response. The objective is to develop and test novel strategies to augment the therapy of exercise training to optimize response and resource utilization in older patients with HFpEF.Read full original descriptionShow less

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

Heart failure with preserved ejection fraction (HFpEF) represents a major public health burden that is both growing rapidly and has few effective therapies. Supervised exercise training (SET) is one of the few effective therapies for older patients with HFpEF, but is currently constrained by cost, resource limitations, and sub-optimal short and long-term clinical response. The objective is to develop and test novel strategies to augment the therapy of exercise training to optimize response and resource utilization in older patients with HFpEF.

Inclusion: 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: 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; Patients with a history of heart transplant or Left Ventricular Assist Device (LVAD), currently on the transplant list; Already engaging in regular moderate to vigorous exercise conditioning defined as >30 minutes per day, ≥twice per week consistently during the previous 6 weeks; Uncontrolled hypertension; Recent or debilitating stroke; Severe pulmonary disease including chronic obstructive pulmonary disease (COPD); 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); 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; Hemoglobin (Hgb) < 9.5 g/dL males and < 9 g/dL females within 30 days prior to enrollment; 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; Inability to meet the expectations of the intervention (i.e., excessive distance from facility, work conflict with intervention).

ClinicalTrials.gov NCT07413198