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New treatment option for Heart Failure NYHA Class II
Official title Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure
ClinicalTrials.gov ID: NCT06313684
What this study is testing
- What it's testing
- CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Santiago, Chile
- Temuco, Chile
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santiago, Chile; Temuco, Chile. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.