Remote Patient Monitoring for Patients With Heart Failure in France (TELESAT-HF)

Satelia

Status: Completed

Conditions: Cardiac Failure; Patient Empowerment; Heart Failure

Treatments: Device: Satelia®Cardio; Other: Conventional care

Study type: Observational

Funder types: Industry

Identifiers

NCT06312501

2021-0020 TELESAT-HF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20,000 participants in 2 patient groups

RPM heart failure patients

Description:

Patients that use RPM for the follow-ups of their condition.

Treatment:

Device: Satelia®Cardio

Real-life heart failure patients recieving conventional care

Description:

Patients that do not use any medical devices and/or solutions such as RPM for the follow-ups of their condition.

Treatment:

Other: Conventional care