Remote Patient Monitoring for Patients With Heart Failure in France

NCT06312501 | Completed DMC

• 1 other identifier: 2021-0020 TELESAT-HF
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Patient Empowerment; Cardiac Failure

Keywords

Remote patient monitoring; Heart failure; Cardiac decompensation; Telehealth

Outcome Measures

Primary Outcomes (1)

• Number of All Causes Deaths

  Number of deaths for any cause

  August 2018 to December 2021

Secondary Outcomes (3)

• Number of unplanned heart failure Hospitalization

  August 2018 to December 2021

• Number of All Causes Deaths in elderly patients

  August 2018 to December 2021

• Number of unplanned hospitalization for heart failure in elderly patients

  August 2018 to December 2021

Study Arms (2)

RPM heart failure patients

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

Device: Satelia®Cardio

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

Interventions

Satelia®Cardio DEVICE

Use of a remote patient monitoring system by NP Medical.

RPM heart failure patients

Conventional care OTHER

No use of RPM solutions for follow-up

Real-life heart failure patients recieving conventional care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20,000 patients with heart failure across France.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Satelia: lead

Study Sites (1)

NP Medical

Bordeaux, 33000, France

Location

Related Publications (3)

• 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.

  PMID: 36034602 BACKGROUND

• 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.

  PMID: 37244215 BACKGROUND

• 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.

  PMID: 38249685 BACKGROUND

Related Links

• Satelia website
• TELESAT study from the data hub

MeSH Terms

Conditions

Heart Failure; Patient Participation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Nicolas Pages, MD

  NP Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 15, 2024
• Study Start: August 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: April 24, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)