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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Patient Empowerment; Cardiac Failure
• Intervention / Treatment: Device: Satelia®Cardio; Other: Conventional care

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 Type: Observational
• Enrollment (Actual): 20000

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • NP Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

20,000 patients with heart failure across France.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RPM heart failure patients; Patients that use RPM for the follow-ups of their condition.	Device: Satelia®Cardio; Use of a remote patient monitoring system by NP Medical.
Real-life heart failure patients recieving conventional care; Patients that do not use any medical devices and/or solutions such as RPM for the follow-ups of their condition.	Other: Conventional care; No use of RPM solutions for follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of All Causes Deaths	Number of deaths for any cause	August 2018 to December 2021

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Satelia
• Investigators: Study Director: Nicolas Pages, MD, NP Medical

Publications and helpful links

General Publications

• Pages N, Picard F, Barritault F, Amara W, Lafitte S, Maribas P, Abassade P, Labarre JP, Boulestreau R, Chaouky H, Abdennadher M, Lemieux H, Lasserre R, Bedel C, Betito L, Nisse-Durgeat S, Diebold B. Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia(R) Cardio). Digit Health. 2022 Aug 22;8:20552076221116774. doi: 10.1177/20552076221116774. eCollection 2022 Jan-Dec.
• Jourdain P, Pages N, Amara W, Maribas P, Lafitte S, Lemieux H, Barritault F, Seronde MF, Labarre JP, Chaouky H, Bedel C, Betito L, Nisse-Durgeat S, Picard F. Perceptions and satisfaction of patients with chronic heart failure when using a remote monitoring web application named Satelia(R) Cardio. Ann Cardiol Angeiol (Paris). 2023 Jun;72(3):101606. doi: 10.1016/j.ancard.2023.101606. Epub 2023 May 25. French.
• Creton S, Saadi M, Monfort H, Yaghobian S, Pages N, Nisse-Durgeat S, Diebold B. The Clinical Impact and Good Practices of Remote Patient Monitoring for Chronic Heart Failure: A French Case Report. Patient Prefer Adherence. 2024 Jan 16;18:131-135. doi: 10.2147/PPA.S445638. eCollection 2024.

Helpful Links

• Satelia website
• TELESAT study from the data hub

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Heart failure; Telehealth; Remote patient monitoring; Cardiac decompensation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2021-0020 TELESAT-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No