NCT07022379

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13,660 (actual)
• Sponsor: Satelia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure
• Heart Failure With Preserved Ejection Fraction (HFPEF)
• Heart Failure With Reduced Ejection Fraction
• Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)

Interventions

Type	Name	Description
OTHER	SGLT2 Inhibitor Use	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-06-15
• Last updated: 2026-03-25

Locations

1 site across 1 country: France