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Remote Patient Monitoring for Patients With Heart Failure in France

Evaluating the Effectiveness of Remote Patient Monitoring (Satelia® Cardio) for Patients With Heart Failure (TELESAT-HF Study)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06312501
Acronym
TELESAT-HF
Enrollment
20000
Registered
2024-03-15
Start date
2018-08-01
Completion date
2022-12-31
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Failure, Heart Failure, Patient Empowerment

Keywords

Remote patient monitoring, Heart failure, Cardiac decompensation, Telehealth

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.

Interventions

DEVICESatelia®Cardio

Use of a remote patient monitoring system by NP Medical.

OTHERConventional care

No use of RPM solutions for follow-up

Sponsors

Satelia
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of All Causes DeathsAugust 2018 to December 2021Number of deaths for any cause

Secondary

MeasureTime frameDescription
Number of unplanned heart failure HospitalizationAugust 2018 to December 2021Number of unplanned hospitalization for heart failure
Number of All Causes Deaths in elderly patientsAugust 2018 to December 2021Number of deaths for any cause in the elderly population
Number of unplanned hospitalization for heart failure in elderly patientsAugust 2018 to December 2021Number of unplanned hospitalization for heart failure in elderly patients

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026