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Completed

NCT Number: NCT07022379

Sodium-Glucose Cotransporter 2 Inhibitor Use in a National Heart Failure Telemonitoring Program

This observational cohort study evaluates temporal trends and determinants of sodium-glucose cotransporter 2 inhibitor (SGLT2i) prescriptions among adults with chronic heart failure enrolled in a nationwide remote monitoring program in France between 2021 and 2024. The analysis examines SGLT2i use at the time of enrollment in relation to left ventricular ejection fraction subgroups and evolving scientific evidence, including major clinical trial publications and guideline updates. Demographic, clinical, and healthcare setting factors associated with SGLT2i prescription in routine clinical practice are assessed using retrospective data from the remote monitoring program database. No study-mandated interventions were performed, and all treatments were prescribed as part of usual care.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NP Medical

Bordeaux, 33000, France

About this study

This retrospective, multicenter observational cohort study was conducted in France between January 1, 2021 and December 31, 2024 within a nationwide heart failure (HF) remote monitoring program. The study included adult patients with chronic heart failure enrolled in the program following hospitalization for HF or in the ambulatory setting with elevated natriuretic peptide levels.

The remote monitoring program supports routine HF management using a digital platform that enables structured follow-up and communication between patients and healthcare providers. Clinical and treatment data recorded at the time of enrollment were extracted from the program database for analysis.

The primary objective of the study is to describe the prevalence of sodium-glucose cotransporter 2 inhibitor (SGLT2i) use at enrollment. Secondary objectives include evaluation of temporal trends in SGLT2i prescriptions across predefined time periods corresponding to major clinical trial publications and guideline updates, and identification of demographic, clinical, and healthcare setting factors associated with SGLT2i use.

Analyses focus on medication use as part of routine clinical care. No study-specific interventions were assigned, and all treatments were prescribed at the discretion of the treating clinicians. Statistical analyses include descriptive methods and multivariable regression modeling to assess factors independently associated with SGLT2i prescription.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • Diagnosis of chronic heart failure
  • Enrolment in the national heart failure remote monitoring program between January 2021 and December 2024
  • Enrolment following hospitalization for heart failure or in the ambulatory setting with elevated natriuretic peptide levels consistent with program eligibility criteria

Exclusion criteria

  • Missing baseline medication data at the time of program enrolment

Treatment and study plan

SGLT2 Inhibitor Use

Other

Prescription of a sodium-glucose cotransporter 2 inhibitor as part of routine clinical care at the time of enrollment in the remote monitoring program. Treatment decisions were made by the treating physician and were not study-mandated.

Primary outcomes

  1. Prevalence of SGLT2 Inhibitor Use at Enrolment

    Time frame: Prescription at time of enrolment into the remote monitoring program (baseline)

    Proportion of patients with chronic heart failure who were prescribed a sodium-glucose cotransporter 2 inhibitor as part of routine clinical care at the time of enrolment in the remote monitoring program.

Secondary outcomes

  1. Temporal Trends in SGLT2 Inhibitor Use

    Time frame: Across four predefined study periods between January 2021 and December 2024

    Changes in the prevalence of SGLT2 inhibitor prescription over time according to study periods corresponding to major clinical trial publications and guideline updates.

  2. Clinical and Healthcare Setting Factors Associated With SGLT2 Inhibitor Use

    Time frame: At time of enrollment (baseline)

    Association between demographic, clinical, and healthcare setting characteristics and likelihood of SGLT2 inhibitor prescription, assessed using multivariable regression analysis.

Sponsors and collaborators

Lead sponsor

Satelia

Industry

Collaborators

  • Central Hospital, Nancy, France

Registry information

Official study title

Temporal Trends and Determinants of Sodium-Glucose Cotransporter 2 Inhibitor Use in Patients Enrolled in a Nationwide Heart Failure Remote Monitoring Program

Acronym: REMOTE-HF

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2025
Registry last updated
Mar 25, 2026

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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