Exercise-based Rehabilitation with or Without Blood Flow Restriction in Individuals with Heart Failure: Protocol for the Rehab-Washout HF Trial.

Background:Heart failure (HF) significantly reduces functional capacity and quality of life in patients classified as New York Heart Association (NYHA) functional class II-III. While cardiopulmonary rehabilitation (CR) is beneficial, innovative strategies are required to improve accessibility and effectiveness for individuals unable to tolerate high hemodynamic loads. Aims:To compare the effects of conventional moderate-to-high intensity resistance training (CRT) versus low-load resistance training combined with blood flow restriction (BFRRT) on clinical, functional, and biochemical outcomes in HF patients. Methods and analysis:This randomized, prospective, parallel-group clinical trial will include 52 patients (NYHA II-III) allocated into CRT (60-80% 1RM) or BFRRT (20-30% 1RM, calibrated at 50% arterial occlusion pressure) groups. The supervised intervention lasts 4 months, with an 8-month post-intervention follow-up. The primary outcome is the change in serum NT-proBNP levels. Secondary outcomes include quality of life, echocardiographic ventricular function, functional capacity, and clinical events. Advanced statistical models and exploratory machine learning analyses with k-fold cross-validation will be utilized for predictive modeling and exploring personalized medicine strategies. Implications:The REHAB-WASHOUT HF trial aims to establish an effective, safe, and accessible therapeutic approach for HF rehabilitation, potentially enhancing clinical outcomes and guiding personalized prescriptive strategies in cardiovascular rehabilitation. Ethics and registration:Approved by the local institutional review board (No. 5.848.965; CAAE 64955022.9.1001.0029). Trial registration: RBR-5y8k7d7.