Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT07345533

EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE

Led by University Hospital, Caen · Updated on 2026-01-15

70

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Chronic heart failure represents a major public health challenge, affecting approximately 64 million people worldwide and generating high costs in terms of mortality, frequent hospitalizations, and medical expenses. In France, this disease is expected to cause nearly 70,000 deaths and 181,000 hospital admissions in 2022. Current management, based on periodic consultations, fails to effectively prevent acute exacerbations, highlighting the importance of technological solutions such as remote monitoring. Objective: This study aims to demonstrate the value of regular monitoring of electrophysiological and mechanical cardiac signals and parameters in patients with chronic heart failure. Its goal is to build a database of signals from an external measuring device to identify parameters that evolve in relation to biological and/or hemodynamic changes and/or the patient's clinical status. The results of this study will enable the further development of an automated monitoring solution for heart failure patients to enable early detection and management of decompensation. Materials and Methods: A total of 70 patients diagnosed with chronic heart failure will be included, including 30 patients hospitalized for heart failure decompensation and 40 patients hospitalized for hemodynamic assessment. Electrophysiological and cardiac mechanical data will be collected using a skin-based measuring device. These data will then be correlated with biological and/or hemodynamic changes and/or the patient's clinical status. They will contribute to the training of an algorithm to detect the risk of decompensation. Hypothesis Tested: The study will test the hypothesis that regular, automated remote monitoring of the data collected during the study can identify the risk of decompensation. Ultimately, this approach could improve the management of heart failure by maintaining a state of balance, while reducing the mental burden on patients.

CONDITIONS

Official Title

EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 90 years
  • Affiliated with the social security system
  • Patients informed about the study who have signed informed consent
  • Patients with heart failure who are either hospitalized for hemodynamic assessment or hospitalized for congestive decompensation of known heart failure defined by minimal dyspnea at rest or during exercise and elevated BNP > 400 µg/ml or NT-proBNP > 1600 µg/ml
Not Eligible

You will not qualify if you...

  • Hospitalization for decompensated heart failure due to infection requiring antibiotics
  • Need for intravenous inotropes within the last 24 hours
  • Presence of ventricular arrhythmias or permanent atrial fibrillation
  • Acute coronary syndrome with ST+ complex complicated by heart failure
  • Valvulopathy awaiting interventional management
  • Pericardial constriction
  • Pregnancy or breastfeeding
  • Women of childbearing potential without effective contraception
  • Under guardianship, curatorship, or legal protection
  • Already enrolled in an interventional clinical trial affecting device measurements
  • Inability to place the sensor on the chest area
  • Open wounds, recent scars, or skin infections at device placement site
  • Dermatitis, eczema, psoriasis, or other skin conditions at placement site
  • Physical or psychological inability to use the digital telemonitoring device or accessories
  • Refusal to transmit necessary data for monitoring use
  • Refusal to receive therapeutic support

AI-Screening

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Trial Site Locations

Total: 1 location

1

Caen University Hospital

Caen, France

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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