NCT06313684 Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure
| NCT ID | NCT06313684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de La Frontera |
| Condition | Heart Failure NYHA Class II |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 152 participants in total. It began in 2024-04-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.
Eligibility 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.
Contact & Investigator
Pamela Seron, PhD
PRINCIPAL INVESTIGATOR
Universidad de La Frontera
Frequently Asked Questions
Who can join the NCT06313684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure NYHA Class II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06313684 currently recruiting?
Yes, NCT06313684 is actively recruiting participants. Contact the research team at mariafrancisca.contreras@ufrontera.cl for enrollment information.
Where is the NCT06313684 trial being conducted?
This trial is being conducted at Santiago, Chile, Santiago, Chile, Santiago, Chile, Temuco, Chile.
Who is sponsoring the NCT06313684 clinical trial?
NCT06313684 is sponsored by Universidad de La Frontera. The principal investigator is Pamela Seron, PhD at Universidad de La Frontera. The trial plans to enroll 152 participants.
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