NCT05525663Recruiting
Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction
Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
The REHAB-HFpEF trial will determine whether a novel physical rehabilitation intervention will improve the primary outcome of combined all-cause rehospitalizations and mortality and the secondary outcome of major mobility disability during 6-month follow-up in patients hospitalized for heart failure and preserved ejection fraction (HFpEF), which is nearly unique to older persons, and for which there are few treatment options.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 880 (estimated)
- First submitted
- 30 Aug 2022
- Start date
- 16 Feb 2023
- Primary completion date
- Nov 2027
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Heart failure
- NCT number
- NCT05525663
What you commit to
- Study type: Interventional
- Planned participants: 880
- From 16 Feb 2023 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Already engaging in regular moderate to vigorous exercise conditioning defined as \>30 minutes per day, \>= twice per week consistently during the previous 6 weeks
Other illness
- Acute myocardial infarction within the past 3 months, or planned coronary artery intervention (percutaneous or surgical) within the next 6 months (Note: given that cardiac biomarkers such as troponin are frequently elevated in HF patients, the diagnosis of acute myocardial infarction should be based on clinical diagnosis, not biomarkers alone)
- Severe valvular heart disease with planned intervention within next 6 months
- Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis)
- Terminal illness other than HF with life expectancy \<1 year
- Impairment from stroke or other medical disorders that preclude participation in the intervention
- Known dementia by medical record documentation, OR patients with Montreal Cognitive Assessment (MoCA) \<=18 AND without social support, OR MoCA \<10 regardless of social support
- Advanced chronic kidney disease defined as estimated glomerular filtration rate \<20 mL/min/1.73 m2 or on chronic or intermittent dialysis or dialysis anticipated within the next 6 months
Other
- Severe aortic or mitral valve stenosis
- Planned discharge other than to home or a facility where the participant will live independently
- Enrollment in a clinical trial not approved for co-enrollment
- High risk for non-adherence as determined by screening evaluation
- Inability or unwillingness to comply with the study requirements or give consent
Who the study is looking for
- Age \>=60 years old
- Ejection Fraction \>=45%
- In the hospital setting \>24 hours for the management of acute decompensated heart failure (ADHF), or diagnosed with ADHF after being hospitalized for another reason. ADHF will be confirmed by the site physician, and will be defined according to the Food and Drug Administration (FDA) definition of hospitalized heart failure as a combination of symptoms, signs, and HF-specific medical treatments, and requires that all 4 of the following are met:
- At least 1 symptom of HF which has worsened from baseline: a. dyspnea at rest or with exertion; b. exertional fatigue; c. orthopnea; d. paroxysmal nocturnal dyspnea (PND)
- At least 2 of the following signs of HF: a. Pulmonary congestion or edema on physical exam (rales or crackles) or by chest X-ray; b. Elevated jugular venous pressure or central venous pressure \>=10 mm Hg; c. peripheral edema; d. wedge or left ventricular end diastolic pressure \>=15 mmHg; e. rapid weight gain (\>=5 lbs.); f. Increased b-type natriuretic peptide (BNP) (\>=100 pg/ml) or N-terminal prohormone BNP (\>=220pg/ml)
- Change in medical treatment specifically targeting HF, defined as change in dose or initiation of or augmentation of at least 1 of the following therapies: a. diuretics; b. vasodilators; c. other neurohormonal modulating agents, including angiotensinconverting enzyme inhibitors, angiotensin II receptor blockers (with or without neprilysin inhibitor), beta-blockers, aldosterone inhibitors, direct renin inhibitors, or sodium-glucose co-transporter-2 inhibitors
- The primary cause of symptoms and signs is judged by the investigator to be due to HF
- Adequate clinical stability to allow participation in study assessments and the intervention Independent with basic activities of daily living, including the ability to ambulate independently (with or without the use of an assistive device) prior to admission
- Able to walk 4 meters (with or without the use of an assistive device) at the time of enrollment
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atrium Health Wake Forest Baptist Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
Related publications
- Physical rehabilitation for older patients with acute HFpEF (REHAB-HFpEF) trial: Design and rationale.Am Heart J · 2026 · PMID 41812966
This page is information, not medical advice. Discuss any trial with your doctor.