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

NCT07022379 | Completed

• 1 other identifier: 2024-REMOTE-HF
• Study Type: observational
• Target: 13,660
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Sodium-glucose cotransporter 2 inhibitors; Guideline-directed medical therapy; Telemonitoring; Remote patient monitoring; Chronic heart failure

Outcome Measures

Primary Outcomes (1)

• Prevalence of SGLT2 Inhibitor Use at Enrolment

  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.

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

Secondary Outcomes (2)

• Temporal Trends in SGLT2 Inhibitor Use

  Across four predefined study periods between January 2021 and December 2024

• Clinical and Healthcare Setting Factors Associated With SGLT2 Inhibitor Use

  At time of enrollment (baseline)

Study Arms (1)

Heart Failure Remote Monitoring Cohort

Adults with chronic heart failure enrolled in a nationwide remote patient monitoring program in France between January 2021 and December 2024. Clinical and treatment data at the time of enrollment were analyzed to evaluate patterns of sodium-glucose cotransporter 2 inhibitor use in routine care.

Other: SGLT2 Inhibitor Use

Interventions

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.

Heart Failure Remote Monitoring Cohort

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

The study population includes adults with chronic heart failure in France who were enrolled in a nationwide remote patient monitoring program between January 2021 and December 2024 as part of routine clinical care. Enrollment typically followed hospitalization for heart failure or occurred in ambulatory patients with elevated natriuretic peptide levels consistent with heart failure management guidelines. The cohort represents patients managed across a range of healthcare settings, including university hospitals, non-university hospitals, and outpatient practices.

You may qualify if:

• 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

You may not qualify if:

• \- Missing baseline medication data at the time of program enrolment

Sponsors & Collaborators

• Satelia: lead
• Central Hospital, Nancy, France: collaborator

Study Sites (1)

NP Medical

Bordeaux, 33000, France

Location

Related Publications (4)

• Solomon SD, McMurray JJV, Claggett B, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Jhund PS, Belohlavek J, Chiang CE, Borleffs CJW, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer-Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Saraiva JFK, Tereshchenko SN, Thierer J, Vaduganathan M, Vardeny O, Verma S, Pham VN, Wilderang U, Zaozerska N, Bachus E, Lindholm D, Petersson M, Langkilde AM; DELIVER Trial Committees and Investigators. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098. doi: 10.1056/NEJMoa2206286. Epub 2022 Aug 27.

  PMID: 36027570 BACKGROUND

• McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.

  PMID: 31535829 BACKGROUND

• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.

  PMID: 37622666 BACKGROUND

• Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.

  PMID: 32865377 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Nicolas Girerd, PhD, MD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

FR (1)