Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT06661161
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Patient diagnosed with chronic heart failure, confirmed by a cardiologist/cardio-geriatrician (regardless of the type and etiology of the disease), meeting at least one of the following two conditions:
* Hospitalization in the past 12 months for a heart failure exacerbation.
* NYHA class II to IV (New York Heart Association) at the time of inclusion, with elevated natriuretic peptide levels (BNP \> 100 pg/mL or NT-proBNP \> 1000 pg/mL).
* French speaking patient
* Patient equipped with a smartphone, computer, or tablet with internet/cellular access (of with the help of a caregiver)
* Patient affiliated with a social security scheme
Exclusion Criteria:
* Patient undergoing dialysis for renal failure
* Patient who has received or is scheduled to receive a heart transplant or circulatory assistance within the next 12 months
* Patient with a left ventricular ejection fraction ≥ 50% (for non-diastolic heart failure)
* Obese patient with a body mass index ≥ 40 kg/m²
* Patient with severe aortic stenosis who is contraindicated for surgery or TAVI
* Patient with a life expectancy of \< 1 year due to a condition other than heart failure (cancer, cirrhosis, respiratory failure, etc.)
* Patient already benefiting from a telemonitoring device
* Physical or psychological inability (dementia, schizophrenia, substance-related disorder) of the patient or caregiver to use the digital data collection device, as judged by the physician
* Patient refusal to allow the transmission of the data necessary for monitoring the effective use of the device and obtaining individualized or national real-world usage results
* Patient under guardianship, curatorship, or any other administrative or judicial measure restricting rights and freedoms
* Patient unable to wear the watch for the duration of the study due to skin conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06661161
Study Brief:
Protocol Section:
NCT06661161