Physical rehabilitation for older patients with acute HFpEF (REHAB-HFpEF) trial: Design and rationale.
Publication/Presentation Date
7-1-2026
Abstract
RATIONALE: Older patients hospitalized for acute decompensated heart failure with preserved ejection fraction (HFpEF) experience persistently poor outcomes, including physical disability, cognitive impairment, depression, impaired health-related quality of life (HRQOL), rehospitalizations, loss of independence, and mortality. In our previous phase 2 REHAB-HF trial, an innovative physical rehabilitation intervention, delivered across three phases-inpatient, 12-week outpatient, and 3-month home-based maintenance-produced large improvements in physical function and HRQOL, with signals of reduced clinical events among patients with acute HFpEF. These findings provide a compelling rationale for a definitive, event-powered trial to evaluate clinical outcomes.
HYPOTHESIS: Targeting physical frailty and multisystem functional impairments using the REHAB-HF intervention-a transitional, tailored, structured, and progressive multidomain rehabilitation program focused on balance, mobility, strength, and endurance-will reduce clinical events in older, predominantly frail patients hospitalized for acute HFpEF.
DESIGN: REHAB-HFpEF is a multicenter, randomized, single-blind, attention-controlled phase 3 trial across 22 U.S. health system centers, enrolling 880 patients aged ≥60 years hospitalized for acute HFpEF. The primary endpoint is combined all-cause rehospitalizations and mortality at 6 months. Key secondary endpoints include major mobility disability (defined as inability to walk ≥160 meters on the 6-minute walk test) and HRQOL measured by the Kansas City Cardiomyopathy Questionnaire. Healthcare costs will also be assessed.
CONCLUSIONS: REHAB-HFpEF is designed to address care gaps for frail older adults with acute HFpEF, who currently lack an evidence-based rehabilitation pathway. If successful in meeting endpoints, this trial could establish a scalable rehabilitation intervention that improves recovery, reduces adverse events, and lowers healthcare costs. Findings may shift HF management paradigms, inform guidelines, and influence national coverage policy for this growing, high-risk population.
CURRENT STATUS: Enrollment ongoing, 478 of 880 (66%) as of 24Feb2027.
TRIAL REGISTRATION: Clinicaltrials.gov ID NCT05525663, https://clinicaltrials.gov/study/NCT05525663?term=NCT05525663&rank=1.
Volume
297
First Page
107420
Last Page
107420
ISSN
1097-6744
Published In/Presented At
Pastva, A. M., Reeves, G. R., Whellan, D. J., Mentz, R. J., Chen, H., Bertoni, A. G., Duncan, P. W., Espeland, M. A., Reed, S. D., Nelson, M. B., O'Connor, C. M., Kitzman, D. W., & REHAB-HFpEF Trial Investigators (2026). Physical rehabilitation for older patients with acute HFpEF (REHAB-HFpEF) trial: Design and rationale. American heart journal, 297, 107420. https://doi.org/10.1016/j.ahj.2026.107420
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
41812966
Department(s)
Administration and Leadership
Document Type
Article