CO-CREATION-HF protocol: clinical trial to evaluate the impact of a comprehensive and hybrid cardiac rehabilitation model on patients with heart failure.

Introduction: Comprehensive, hybrid cardiac rehabilitation (CR) models have been scantly investigated in heart failure (HF) populations, particularly in low-resource settings. CO-CREATION-HF aims to evaluate the effectiveness of such a model compared to supervised exercise alone. Methods and analysis: A 2 parallel-arm, multi-center randomized clinical superiority trial will be conducted with blinded outcome assessment. 152 HF patients (NYHA class II or III) will be recruited consecutively, and randomly assigned using permuted blocks; allocation will be concealed. The 12-week intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise training, psychosocial support, and education. These will initially be delivered in a center, transitioning to home in 4 stages. Controls will receive similar management, but face-to-face continuous aerobic exercise sessions and resistance exercises. The main outcomes are cardiorespiratory fitness (VO Ethics and dissemination: The study protocol and the Informed Consent form were approved by Ethical Committees at the Universidad de La Frontera (No. 081-23) and each center participating. Research findings will be disseminated to the scientific community and will be shared with relevant stakeholder groups and policy-makers. Finally, investigators shall reach HF patients via various dissemination channels such as social media. Clinical Trial Registration: clinicaltrials.gov, identifier (NCT06313684).