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Recruiting NCT05525663

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

Trial Parameters

Condition Heart Failure With Preserved Ejection Fraction
Sponsor Wake Forest University Health Sciences
Study Type INTERVENTIONAL
Phase N/A
Enrollment 880
Sex ALL
Min Age 60 Years
Max Age N/A
Start Date 2023-02-16
Completion 2027-11
Interventions
Rehabilitation Intervention

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Age \>=60 years old 2. Ejection Fraction \>=45% 3. 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 we

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