Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction

This study is testing a new physical rehabilitation program for older adults (age 60 and above) who have been hospitalized for acute heart failure with preserved ejection fraction (HFpEF). HFpEF means your heart can pump blood, but it's too stiff to fill properly. The program involves progressive exercises and activities, starting in the hospital and continuing for 12 weeks after you go home. Researchers want to see if this program can reduce the number of times people are rehospitalized or die within 6 months. They also want to see if it helps improve your ability to move around. This study is for people aged 60 or older who have an ejection fraction (a measure of how well your heart pumps blood) of 45% or higher and were hospitalized for heart failure.

Study design
This is a randomized, single-blind study involving 880 participants. Participants will be assigned by chance to either receive the rehabilitation intervention or a control.
What's involved
The rehabilitation program starts during hospitalization and continues for 12 weeks in an outpatient setting, followed by a maintenance program.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after starting the intervention to measure rehospitalization, death, and mobility.

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NCT05525663

Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction

Recruiting
NAAges 60+InterventionalTreatment
Wake Forest University Health Sciences
~880 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Rehabilitation Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Combined All-cause Rehospitalization and Death
Measured over Month 6
Heart Failure With Preserved Ejection Fraction
1 sites across 1 states
North Carolina1
  • Dalane W Kitzman, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

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Eligibility criteria

Inclusion

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 4. 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 5. Able to walk 4 meters (with or without the use of an assistive device) at the time of enrollment
  • Combined All-cause Rehospitalization and DeathMonth 6

    Rate of combined all-cause rehospitalizations and death 6 months following discharge from index hospitalization.