Remote Patient Monitoring for Patients With Heart Failure in France

Completed

• Conditions: Patient Empowerment; Heart Failure; Cardiac Failure
• Interventions: Device: Satelia®Cardio; Other: Conventional care

• Registration Number: NCT06312501
• Lead Sponsor: Satelia

Brief Summary

The goal of this multicenter observational longitudinal cohort study is to evaluate the ability of a Remote Patient Monitoring (RPM) program to prevent cardiac decompensation by detecting weak signals of decompensation early in patients with chronic heart failure in France.

The main question it aims to answer is whether an RPM solution can provide the improvement in overall patient survival

Participants will answer to questionnaires provided by the RPM solution for the follow-up of their condition.

Researchers will compare the following cohorts to see if RPM can improve their condition:

* Cohort 1: using RPM for follow-ups.

* Cohort 2: conventional care and not using any devices and solutions for the follow-ups.

Detailed Description

TELESAT study is a national-scale observational prospective cohort study conducted in France from August 2018 to December 2022.

The study was conducted using the French national health data system known as the Système National des Données de Santé (SNDS) which covers approximately 99% of the French population.

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-15
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• residing in France
• having heart failure
• adults over the age of 18 years
• New York Heart Association (NYHA) score≥2 and Brain Natriuretic Peptid (BNP)>100 pg/ml or N-terminal pro BNP>1000 pg/ml OR prior hospitalization for heart failure

Exclusion Criteria

• physician's assessment deemed patient not be physically or mentally able to be remotely monitored
• had chronic dialysis
• severe liver failure
• the presence of any other medical condition resulting in a less than one-year life expectancy,
• an estimated low adherence to treatment
• lack of a stable place of residence
• refusing to participate in the program ineligible.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RPM heart failure patients	Satelia®Cardio	Patients that use RPM for the follow-ups of their condition.
Real-life heart failure patients recieving conventional care	Conventional care	Patients that do not use any medical devices and/or solutions such as RPM for the follow-ups of their condition.

Primary Outcome Measures

Name	Time	Method
Number of All Causes Deaths	August 2018 to December 2021	Number of deaths for any cause

Secondary Outcome Measures

Name	Time	Method
Number of All Causes Deaths in elderly patients	August 2018 to December 2021	Number of deaths for any cause in the elderly population
Number of unplanned hospitalization for heart failure in elderly patients	August 2018 to December 2021	Number of unplanned hospitalization for heart failure in elderly patients
Number of unplanned heart failure Hospitalization	August 2018 to December 2021	Number of unplanned hospitalization for heart failure

Trial Locations

Locations (1)

NP Medical; 🇫🇷 Bordeaux, France