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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Rehabilitation Intervention
Behavioral
progressive, multi-domain rehabilitation and exercise training intervention

Treatment groups

880 Participants

are divided into 2 treatment groups

Group A: Rehabilitation InterventionExperimental treatment 1 intervention

Group B: Attention ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Combined All-cause Rehospitalization and Death

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

Time frame

Month 6

Secondary outcomes

Prevalence of major mobility disability (MMD)

Percentage of participants with MMD, defined as the inability to walk 160 meters during a 6 minute walk test.

Time frame

Month 6

Other outcomes

All-cause rehospitalization

Exploratory outcome. Rate of rehospitalizations 6 months following discharge from index hospitalization.

Time frame

Month 6

All-cause death

Exploratory outcome. Rate of death 6 months following discharge from index hospitalization.

Time frame

Month 6

Cardiovascular rehospitalization and death

Exploratory outcome. Rate of combined cardiovascular rehospitalizations and death 6 months following discharge from index hospitalization.

Time frame

Month 6

Short Physical Performance Battery (SPPB)

Exploratory outcome. The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function.

Time frame

Month 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

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