Heart FailureREMOTE-HFNCT07022379
Sodium-Glucose Cotransporter 2 Inhibitor Use in a National Heart Failure Telemonitoring Program
An observational study of Heart Failure and Heart Failure With Preserved Ejection Fraction (HFPEF), run by Satelia at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Reduced Ejection Fraction
- What is being tested?
- SGLT2 Inhibitor Use
- How many people
- 13,660 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Missing baseline medication data at the time of program enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal Trends and Determinants of Sodium-Glucose Cotransporter 2 Inhibitor Use in Patients Enrolled in a Nationwide Heart Failure Remote Monitoring 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.
Read the 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)
- Being tested
- SGLT2 Inhibitor Use
- Keywords
- Sodium-glucose cotransporter 2 inhibitors, Guideline-directed medical therapy, Telemonitoring, Remote patient monitoring, Chronic heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 Inhibitor UseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: SGLT2 Inhibitor Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prescription at time of enrolment into the remote monitoring program (baseline)
Secondary outcomes (2)
Temporal Trends in SGLT2 Inhibitor Use
Changes in the prevalence of SGLT2 inhibitor prescription over time according to study periods corresponding to major clinical trial publications and guideline updates.
Measured: Across four predefined study periods between January 2021 and December 2024
Clinical and Healthcare Setting Factors Associated With SGLT2 Inhibitor Use
Association between demographic, clinical, and healthcare setting characteristics and likelihood of SGLT2 inhibitor prescription, assessed using multivariable regression analysis.
Measured: At time of enrollment (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satelia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Central Hospital, Nancy, France
- Responsible party
- Sponsor
- Investigators
- Nicolas Girerd, PhD, MD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022379
- Sponsor's protocol ID
- 2024-REMOTE-HF
- Acronym
- REMOTE-HF
- Status last verified
- Mar 2026
- First submitted
- 6 Jun 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36027570McMurray 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.
PubMed 31535829McDonagh 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.
PubMed 37622666Packer 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.
PubMed 32865377Monzo 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.
PubMed 42480823
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Trends and Determinants of Sodium-Glucose Cotransporter 2 Inhibitor Use in Patients Enrolled in a Nationwide Heart Failure Remote Monitoring Program
- ClinicalTrials.gov ID
- NCT07022379
- Acronym / sponsor ID
- REMOTE-HF / 2024-REMOTE-HF
- Conditions
- Heart Failure, Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Reduced Ejection Fraction, 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,660 participants (actual)
- Lead sponsor
- SateliaIndustry (pharma, biotech, devices)
- Collaborators
- Central Hospital, Nancy, France
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Remote Monitoring Cohort | – | Other: SGLT2 Inhibitor UseAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Missing baseline medication data at the time of program enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 Inhibitor UsePrescription 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. | Other | Heart Failure Remote Monitoring Cohort |
Primary outcome
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.
2 secondary outcomes
Temporal Trends in SGLT2 Inhibitor Use
Time frame: Across four predefined study periods between January 2021 and December 2024
Clinical and Healthcare Setting Factors Associated With SGLT2 Inhibitor Use
Time frame: At time of enrollment (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 36027570Solomon 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.
- Background: PubMed 31535829McMurray 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.
- Background: PubMed 37622666McDonagh 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.
- Background: PubMed 32865377Packer 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.
- Derived from this study: PubMed 42480823Monzo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Girerd, PhD, MD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Failure With Preserved Ejection Fraction (HFPEF), run by Satelia at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of SGLT2 Inhibitor Use at Enrolment (time frame: Prescription at time of enrolment into the remote monitoring program (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07022379, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.