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Completed

NCT Number: NCT06312501

Remote Patient Monitoring for Patients With Heart Failure in France

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.

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Key information

Conditions

Heart Failure Behavior Cardiac Failure Cardiovascular Diseases Health Behavior Heart Diseases Patient Acceptance of Health Care Patient Empowerment Patient Participation Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NP Medical

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Satelia®Cardio

Device

Use of a remote patient monitoring system by NP Medical.

Conventional care

Other

No use of RPM solutions for follow-up

Primary outcomes

  1. Number of All Causes Deaths

    Time frame: August 2018 to December 2021

    Number of deaths for any cause

Secondary outcomes

  1. Number of unplanned heart failure Hospitalization

    Time frame: August 2018 to December 2021

    Number of unplanned hospitalization for heart failure

  2. Number of All Causes Deaths in elderly patients

    Time frame: August 2018 to December 2021

    Number of deaths for any cause in the elderly population

  3. Number of unplanned hospitalization for heart failure in elderly patients

    Time frame: August 2018 to December 2021

    Number of unplanned hospitalization for heart failure in elderly patients

Sponsors and collaborators

Lead sponsor

Satelia

Industry

Registry information

Official study title

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

Acronym: TELESAT-HF

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Mar 15, 2024
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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