About this trial
The goal of the study is to calibrate the algorithmic model of the TakeCoeur AI device to detect early heart failure decompensation in patients with heart failure, using physiological data (clinical) actively and passively collected through connected medical devices (watch, blood pressure monitor, and scale).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
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
Disqualifiers
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
Trial population
Participation in the study will be offered to any patient consulting a cardiologist/cardio-geriatrician at one of the participating centers who meets the inclusion criteria and non inclusion criteria.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Concordance between the detection of heart failure decompensation by the TakeCoeur AI device and the occurrence of heart failure decompensation
calibrate the algorithmic model of the TakeCoeur IA device for early detection of cardiac decompensation in patients suffering from heart failure.
Secondary outcomes
Evaluate the time (in days) to anticipate cardiac decompensation
time to predict (in days) the risk of cardiac decompensation
Evaluate the compliance of patients with heart failure to the Takecoeur IA device and its connected collection accessories
\- Monthly questionnaire (scale 0 to 4 for edema and shortness of breath) completion rate defined by the following formula: (number of completed questionnaires / total number of questionnaires to be completed) x 100
Sponsors and contacts
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