Ireland
--:--IST
Starting soon Observational

Calibration of AlgoRithm for Detection of Cardiac Decompensation Via Parametric Objects (CARDCOP)

NCT06661161 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-11
Last updated
2024-10-28

Condition(s) studied

Heart Failure - NYHA II - IV

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Concordance between the detection of heart failure decompensation by the TakeCoeur AI device and the occurrence of heart failure decompensation — From enrollment to the end of the 6-month follow-up period.
    calibrate the algorithmic model of the TakeCoeur IA device for early detection of cardiac decompensation in patients suffering from heart failure.

Trial sites (3)

FacilityCityRegionStatus
Chu Brest Brest France
CH Morlaix Morlaix France
CH Vannes Vannes France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06661161 on ClinicalTrials.gov ↗ ← All trials in France