NCT07855471

Brief Summary

This retrospective, multicenter observational cohort study evaluates adults with heart failure enrolled in the Satelia® Cardio telemonitoring program in France between 28 August 2018 and 6 July 2026. Participants are classified according to the location of their follow-up center into a French overseas departments cohort, comprising Martinique, Guadeloupe, and La Réunion, and a mainland France cohort. The study evaluates regional differences in clinical characteristics, telemonitoring organization and engagement, guideline-directed medical therapy (GDMT) use, and follow-up status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32,380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

7.9 years

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Keywords

telemonitoringremote patient monitoringFrench overseas territoriesguideline-directed medical therapyleft ventricular ejection fractionhealth equity

Outcome Measures

Primary Outcomes (4)

  • Clinical Profile of Participants by Geographic Cohort

    Demographic and clinical characteristics of participants in the French overseas departments and mainland France cohorts, including age, sex, New York Heart Association functional class, left ventricular ejection fraction category, heart failure etiology, cardiovascular risk factors, and comorbidities.

    At enrollment in the Satelia Cardio remote monitoring program

  • Telemonitoring Organization and Engagement by Geographic Cohort

    Telemonitoring organization and engagement, including monitoring mode, monitoring frequency, questionnaire adherence, triggered clinical alerts, and duration of follow-up, compared between the French overseas departments and mainland France cohorts.

    From enrollment through the end of follow-up, up to 6 July 2026.

  • Guideline-Directed Medical Therapy Exposure by Geographic Cohort

    Proportion of participants with recorded exposure to beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors. Exposure to a therapeutic class is defined as at least one prescription for that class recorded at any time during follow-up. Three-class and four-class GDMT are also assessed, with four-class GDMT defined as recorded exposure to beta-blocker, renin-angiotensin system inhibition (ARNI, ACEi, or ARB), MRA, and SGLT2i; concurrent use at a single time point is not required.

    During telemonitoring follow-up, through 6 July 2026

  • Retention Under Telemonitoring and Reasons for Discontinuation

    Proportion of participants remaining under telemonitoring at the end of follow-up and distribution of recorded reasons for discontinuation, including death, patient-initiated discontinuation, and care-team-initiated discontinuation.

    Status at the end of follow-up, through 6 July 2026.

Secondary Outcomes (1)

  • Guideline-Directed Medical Therapy by Left Ventricular Ejection Fraction Category

    During telemonitoring follow-up, through 6 July 2026.

Study Arms (2)

French Overseas Territories (DOM)

Adults with heart failure enrolled in the Satelia Cardio remote monitoring program and followed by one of nine participating centers located in Martinique, Guadeloupe, or La Réunion.

Mainland France

Adults with heart failure enrolled in the Satelia Cardio remote monitoring program and followed by participating centers located in mainland France.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with heart failure enrolled in the Satelia® Cardio telemonitoring program in France between 28 August 2018 and 6 July 2026. Participants were classified according to the location of the center responsible for their follow-up as either the French overseas departments cohort, comprising Martinique, Guadeloupe, and La Réunion, or the mainland France cohort.

You may qualify if:

  • Age 18 years or older.
  • Diagnosis of heart failure.
  • Enrollment in the Satelia® Cardio telemonitoring program between 28 August 2018 and 6 July 2026.
  • Follow-up by a participating center in either the French overseas departments of Martinique, Guadeloupe, or La Réunion, or mainland France.

You may not qualify if:

  • \- Follow-up center could not be determined from the extracted data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NP Médical / Satelia

Bordeaux, Nouvelle-Aquitane, 33000, France

Location

Related Publications (2)

  • Girerd N, Barbet V, Seronde MF, Benchimol H, Jagu A, Tartiere JM, Hanon O, Picard F, Lafitte S, Lemaitre M, Pages N, Nisse-Durgeat S, Jourdain P. Association of a remote monitoring programme with all-cause mortality and hospitalizations in patients with heart failure: National-scale, real-world evidence from a 3-year propensity score analysis of the TELESAT-HF study. Eur J Heart Fail. 2025 Sep;27(9):1658-1669. doi: 10.1002/ejhf.3563. Epub 2025 Jan 14.

    PMID: 39807086BACKGROUND
  • Monzo L, Hanon O, Savarese G, Fauvel C, Berthelot E, Seronde MF, Assyag P, Esser R, Picard F, Pages N, Nisse-Durgeat S, Girerd N. Temporal trends and factors associated with SGLT2 inhibitor prescription in a nationwide French heart failure remote monitoring program. Int J Cardiol. 2026 Jul 21;462:134683. doi: 10.1016/j.ijcard.2026.134683. Online ahead of print.

    PMID: 42480823BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 2, 2026

Study Start

August 28, 2018

Primary Completion

July 6, 2026

Study Completion

July 6, 2026

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant-level data will not be made publicly available because the study is based on pseudonymised routine-care health data subject to applicable data-protection and governance requirements.

Locations