Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure
Recruiting · NCT06313684 · Interventional (participants receive a specific treatment) · Lead sponsor: Universidad de La Frontera
View the official record on ClinicalTrials.gov →Interventions studied
Comprehensive Initial AssessmentContinuous evaluationContinuous exerciseDiet managementInitial AssessmentInterval ExercisePsychosocial supportResistance exercise
What this trial is about
CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
4 locations listed.
- Complejo Hospitalario San José - Santiago, Chile
- Hospital Clínico Universidad de Chile - Santiago, Chile
- Hospital San Borja Arriarán - Santiago, Chile
- Universidad de La Frontera - Temuco, Chile