Hybrid cardiac rehabilitation for heart failure patients
Comprehensive Hybrid Cardiac Rehabilitation Trial to Assess Impact on Heart Failure Patients
This study is testing if a new combined approach to heart rehab that includes exercise, medical support, and education helps people with heart failure feel better and improve their fitness more than just supervised exercise alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad de La Frontera Academic / other |
| Locations | 4 sites (Santiago and 3 other locations) |
| Trial ID | NCT06313684 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a comprehensive hybrid cardiac rehabilitation model compared to supervised exercise alone for patients with heart failure. It involves a multi-center, randomized clinical trial design with two parallel arms, where participants will receive either a comprehensive intervention including medical management, exercise, psychosocial support, and education, or standard supervised exercise. The study aims to assess improvements in cardiorespiratory fitness, functional capacity, and quality of life over time. Participants will transition from center-based to home-based rehabilitation in a structured manner.
Who should consider this trial
Good fit: Ideal candidates are adults with heart failure classified as NYHA Class II or III who are stable and on optimal medical therapy.
Not a fit: Patients with severe comorbidities or those who have recently undergone cardiac procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and functional capacity for heart failure patients.
How similar studies have performed: Other studies have shown promising results with hybrid rehabilitation approaches in similar populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with HF of New York Heart Association functional class II or III. * Meets HF diagnostic criteria of Guidelines * On optimal tolerated medical therapy. * Deemed by the treating physician as stable for at least 1 month. * Able to attend the health center three times a week for the first month, and twice a week for the 2nd and 3rd months * Owns a mobile phone * Patient consents to participate in the study by signing an informed consent form. Exclusion Criteria: * Chronic kidney disease with glomerular filtration rate \< 20 mL/min. * Decompensated thyroid disease. * End-stage liver failure or Child-Pugh C. * Cardiac device or cardiac surgery in the previous month or planned in the next 3 months. * Patients with dyspnea predominantly of non-cardiac cause (e.g. COPD). * Atrial fibrillation with a heart rate greater than 90 beats per minute at rest. * Active neoplasm with life expectancy \<2 years. * Inclusion in another interventional study. * Explicit contraindications to performing exercise. * Comorbidities that preclude the patient from engaging in a CR program. * Musculoskeletal or neurological disease that precludes the patient from performing exercise.
Where this trial is running
Santiago and 3 other locations
- Complejo Hospitalario San José — Santiago, Chile (Recruiting)
- Hospital Clínico Universidad de Chile — Santiago, Chile (Recruiting)
- Hospital San Borja Arriarán — Santiago, Chile (Recruiting)
- Universidad de La Frontera — Temuco, Chile (Recruiting)
Study contacts
- Principal investigator: Pamela Seron, PhD — Universidad de La Frontera
- Study coordinator: Francisca Contreras
- Email: mariafrancisca.contreras@ufrontera.cl
- Phone: 56045 2325765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.