Health Trials

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

ConditionHeart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorWake Forest University Health Sciences

About this trial

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

Qualifiers

Age >=60 years old

Ejection Fraction >=45%

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)

Disqualifiers

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 aortic or mitral valve stenosis

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)

Trial design

Treatments tested in this trial

  • Rehabilitation Intervention

Treatment groups

880 Participants
are divided into 2 treatment groups

Locations

1
Atrium Health Wake Forest Baptist27157, Winston-SalemNorth Carolina, United States

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov