NCT06313684Recruiting
Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure
Comprehensive Hybrid Cardiac Rehabilitation Trial to Assess Impact on Heart Failure Patients
Source: ClinicalTrials.gov · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 152 (estimated)
- First submitted
- 4 Mar 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Universidad de La Frontera
- Diseases
- Heart failure
- NCT number
- NCT06313684
What you commit to
- Study type: Interventional
- Planned participants: 152
- From 1 Apr 2024 to the primary completion date, 30 Sept 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cardiac device or cardiac surgery in the previous month or planned in the next 3 months.
Other illness
- Chronic kidney disease with glomerular filtration rate \< 20 mL/min.
- Decompensated thyroid disease.
- End-stage liver failure or Child-Pugh C.
- 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.
- Musculoskeletal or neurological disease that precludes the patient from performing exercise.
Age
- Active neoplasm with life expectancy \<2 years.
Other
- Inclusion in another interventional study.
- Explicit contraindications to performing exercise.
- Comorbidities that preclude the patient from engaging in a CR program.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clínico Universidad de Chile Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Hospital San Borja Arriarán Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Complejo Hospitalario San José Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Universidad de La Frontera Coordinator of this site? Confirm its status | Temuco | Chile | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.