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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of the 6-month follow-up period.

Secondary outcomes

1

Evaluate the time (in days) to anticipate cardiac decompensation

time to predict (in days) the risk of cardiac decompensation

Time frame
From enrollment to the end of the 6-month follow-up period.
2

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

Time frame
From enrollment to the end of the 6-month follow-up period.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: