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

NCT06661161 | Not Yet Recruiting

• 1 other identifier: 29BRC24.0222 - CARDCOP
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Heart Failure - NYHA II - IV

Outcome Measures

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.

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

Secondary Outcomes (2)

• Evaluate the time (in days) to anticipate cardiac decompensation

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

• Evaluate the compliance of patients with heart failure to the Takecoeur IA device and its connected collection accessories

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (3)

Chu Brest

Brest, 29609, France

Location

CH Morlaix

Morlaix, 29600, France

Location

CH Vannes

Vannes, 56000, France

Location

Central Study Contacts

Jacques MANSOURATI

CONTACT

0298347405; jacques.mansourati@chu-brest.fr

Maxime PASQUIER

CONTACT

0649476976; pasquier@e-medys.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 28, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (3)