Rehabilitation for older patients with heart failure

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

This study is testing a new physical rehabilitation program for older patients with heart failure to see if it helps them stay out of the hospital and improves their mobility.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 880 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT05525663 on ClinicalTrials.gov

What this trial studies

The REHAB-HFpEF trial aims to evaluate a novel physical rehabilitation intervention for older patients hospitalized with acute heart failure and preserved ejection fraction. This multicenter, randomized, attention-controlled trial will involve 880 participants aged 60 and older, who will be assigned to either the rehabilitation program or an attention control group. The intervention focuses on a tailored, progressive approach that includes strength, balance, and endurance training, starting during hospitalization and continuing for 12 weeks in an outpatient setting. The primary goal is to reduce rehospitalizations and mortality, while the secondary goal is to decrease major mobility disability over a 6-month follow-up period.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 and older who have been hospitalized for acute decompensated heart failure with preserved ejection fraction.

Not a fit: Patients with ejection fractions below 45% or those not hospitalized for heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve recovery outcomes and quality of life for older patients with heart failure.

How similar studies have performed: Preliminary studies, including the phase 2 REHAB-HF trial, suggest that similar rehabilitation approaches may yield significant benefits for this patient population.

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 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

Exclusion Criteria:

1. 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)
2. Severe aortic or mitral valve stenosis
3. Severe valvular heart disease with planned intervention within next 6 months
4. Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis)
5. Planned discharge other than to home or a facility where the participant will live independently
6. Terminal illness other than HF with life expectancy \<1 year
7. Impairment from stroke or other medical disorders that preclude participation in the intervention
8. 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
9. 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
10. Already engaging in regular moderate to vigorous exercise conditioning defined as \>30 minutes per day, \>= twice per week consistently during the previous 6 weeks
11. Enrollment in a clinical trial not approved for co-enrollment
12. High risk for non-adherence as determined by screening evaluation
13. Inability or unwillingness to comply with the study requirements or give consent

Where this trial is running

Winston-Salem, North Carolina

• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Dalane W Kitzman, MD — Wake Forest University Health Sciences
• Study coordinator: Michael B Nelson, MS

Conditions Heart Failure With Preserved Ejection Fraction