NP Medical
Bordeaux, 33000, France
NCT Number: NCT07022379
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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Notify Me18 year and older
All sexes
Observational
Bordeaux, 33000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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Industry
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
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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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