Heart FailureDOM-HFNCT07855471
Heart Failure Telemonitoring Across French Overseas Departments and Mainland France
An observational study of Heart Failure, run by Satelia at 1 site in France.
Trial summary
This retrospective, multicenter observational cohort study evaluates adults with heart failure enrolled in the Satelia® Cardio telemonitoring program in France between 28 August 2018 and 6 July 2026. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 32,380 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2018to 6 Jul 2026
- 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: Adults with heart failure enrolled in the Satelia® Cardio telemonitoring program in France between 28 August 2018 and 6 July 2026. Participants were classified according to the location of the center responsible for their follow-up as either the French overseas departments cohort, comprising Martinique, Guadeloupe, and La Réunion, or the mainland France cohort.
Who may be able to join
- Age 18 years or older.
- Diagnosis of heart failure.
- Enrollment in the Satelia® Cardio telemonitoring program between 28 August 2018 and 6 July 2026.
- Follow-up by a participating center in either the French overseas departments of Martinique, Guadeloupe, or La Réunion, or mainland France.
Who cannot join
- Follow-up center could not be determined from the extracted data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Geographic Differences in Clinical Profiles, Telemonitoring Organization, and Guideline-Directed Medical Therapy in Heart Failure Across France.
This retrospective, multicenter observational cohort study evaluates adults with heart failure enrolled in the Satelia® Cardio telemonitoring program in France between 28 August 2018 and 6 July 2026. Participants are classified according to the location of their follow-up center into a French overseas departments cohort, comprising Martinique, Guadeloupe, and La Réunion, and a mainland France cohort. The study evaluates regional differences in clinical characteristics, telemonitoring organization and engagement, guideline-directed medical therapy (GDMT) use, and follow-up status.
Read the detailed description
This study is a retrospective, multicenter comparative cohort analysis based on routinely collected data from the Satelia® Cardio heart failure telemonitoring program. All adult patients with heart failure enrolled in the program between 28 August 2018 and 6 July 2026 were eligible for inclusion. Participants are categorized according to the geographic location of the center responsible for their follow-up. The overseas cohort comprises patients followed in ten centers across Martinique, Guadeloupe, and La Réunion, while the comparison cohort comprises patients followed in mainland France. Patients whose follow-up center could not be determined were excluded, leaving 32,380 patients for analysis.
Variables assessed include age, sex, NYHA functional class, LVEF, heart failure etiology, cardiovascular risk factors and comorbidities, monitoring mode and frequency, questionnaire adherence, triggered alerts, duration of follow-up, guideline-directed medical therapy, follow-up status, and reasons for discontinuation. Guideline-directed medical therapy is evaluated according to therapeutic class, including beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors. Patients are considered exposed to a therapeutic class if at least one prescription for that class was recorded at any time during follow-up. Three-class and four-class GDMT are also assessed; four-class GDMT denotes recorded exposure to all four foundational treatment classes and does not require documented simultaneous use at a single time point. Analyses of NYHA class, LVEF, and heart failure etiology are restricted to participants with available data. Guideline-directed medical therapy is additionally assessed according to left ventricular ejection fraction category.
- Conditions
- Heart Failure
- Keywords
- telemonitoring, remote patient monitoring, French overseas territories, guideline-directed medical therapy, left ventricular ejection fraction, health equity
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| French Overseas Territories (DOM) | Adults with heart failure enrolled in the Satelia Cardio remote monitoring program and followed by one of nine participating centers located in Martinique, Guadeloupe, or La Réunion. | |
| Mainland France | Adults with heart failure enrolled in the Satelia Cardio remote monitoring program and followed by participating centers located in mainland France. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Profile of Participants by Geographic Cohort
Demographic and clinical characteristics of participants in the French overseas departments and mainland France cohorts, including age, sex, New York Heart Association functional class, left ventricular ejection fraction category, heart failure etiology, cardiovascular risk factors, and comorbidities.
Measured: At enrollment in the Satelia Cardio remote monitoring program
Telemonitoring Organization and Engagement by Geographic Cohort
Telemonitoring organization and engagement, including monitoring mode, monitoring frequency, questionnaire adherence, triggered clinical alerts, and duration of follow-up, compared between the French overseas departments and mainland France cohorts.
Measured: From enrollment through the end of follow-up, up to 6 July 2026.
Guideline-Directed Medical Therapy Exposure by Geographic Cohort
Proportion of participants with recorded exposure to beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors. Exposure to a therapeutic class is defined as at least one prescription for that class recorded at any time during follow-up. Three-class and four-class GDMT are also assessed, with four-class GDMT defined as recorded exposure to beta-blocker, renin-angiotensin system inhibition (ARNI, ACEi, or ARB), MRA, and SGLT2i; concurrent use at a single time point is not required.
Measured: During telemonitoring follow-up, through 6 July 2026
Retention Under Telemonitoring and Reasons for Discontinuation
Proportion of participants remaining under telemonitoring at the end of follow-up and distribution of recorded reasons for discontinuation, including death, patient-initiated discontinuation, and care-team-initiated discontinuation.
Measured: Status at the end of follow-up, through 6 July 2026.
Secondary outcomes (1)
Guideline-Directed Medical Therapy by Left Ventricular Ejection Fraction Category
Guideline-directed medical therapy exposure assessed within reduced left ventricular ejection fraction (<40%), mildly reduced left ventricular ejection fraction (40-49%), and preserved left ventricular ejection fraction (≥50%) categories. GDMT exposure is based on recorded prescriptions during follow-up.
Measured: During telemonitoring follow-up, through 6 July 2026.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start28 Aug 2018
- Primary completion6 Jul 2026
- Study completion6 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 32,380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satelia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Center of Martinique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855471
- Sponsor's protocol ID
- DOM-HF-2026
- Acronym
- DOM-HF
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be made publicly available because the study is based on pseudonymised routine-care health data subject to applicable data-protection and governance requirements.
Publications
Girerd N, Barbet V, Seronde MF, Benchimol H, Jagu A, Tartiere JM, Hanon O, Picard F, Lafitte S, Lemaitre M, Pages N, Nisse-Durgeat S, Jourdain P. Association of a remote monitoring programme with all-cause mortality and hospitalizations in patients with heart failure: National-scale, real-world evidence from a 3-year propensity score analysis of the TELESAT-HF study. Eur J Heart Fail. 2025 Sep;27(9):1658-1669. doi: 10.1002/ejhf.3563. Epub 2025 Jan 14.
PubMed 39807086Monzo 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geographic Differences in Clinical Profiles, Telemonitoring Organization, and Guideline-Directed Medical Therapy in Heart Failure Across France.
- ClinicalTrials.gov ID
- NCT07855471
- Acronym / sponsor ID
- DOM-HF / DOM-HF-2026
- Conditions
- Heart Failure
- Keywords
- telemonitoring, remote patient monitoring, French overseas territories, guideline-directed medical therapy, left ventricular ejection fraction, health equity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32,380 participants (actual)
- Lead sponsor
- SateliaIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Center of Martinique
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 2 Oct 2026 (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 retrospective, multicenter observational cohort study evaluates adults with heart failure enrolled in the Satelia® Cardio telemonitoring program in France between 28 August 2018 and 6 July 2026. Participants are classified according to the location of their follow-up center into a French overseas departments cohort, comprising Martinique, Guadeloupe, and La Réunion, and a mainland France cohort. The study evaluates regional differences in clinical characteristics, telemonitoring organization and engagement, guideline-directed medical therapy (GDMT) use, and follow-up status.
Detailed description
This study is a retrospective, multicenter comparative cohort analysis based on routinely collected data from the Satelia® Cardio heart failure telemonitoring program. All adult patients with heart failure enrolled in the program between 28 August 2018 and 6 July 2026 were eligible for inclusion. Participants are categorized according to the geographic location of the center responsible for their follow-up. The overseas cohort comprises patients followed in ten centers across Martinique, Guadeloupe, and La Réunion, while the comparison cohort comprises patients followed in mainland France. Patients whose follow-up center could not be determined were excluded, leaving 32,380 patients for analysis.
Variables assessed include age, sex, NYHA functional class, LVEF, heart failure etiology, cardiovascular risk factors and comorbidities, monitoring mode and frequency, questionnaire adherence, triggered alerts, duration of follow-up, guideline-directed medical therapy, follow-up status, and reasons for discontinuation. Guideline-directed medical therapy is evaluated according to therapeutic class, including beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors. Patients are considered exposed to a therapeutic class if at least one prescription for that class was recorded at any time during follow-up. Three-class and four-class GDMT are also assessed; four-class GDMT denotes recorded exposure to all four foundational treatment classes and does not require documented simultaneous use at a single time point. Analyses of NYHA class, LVEF, and heart failure etiology are restricted to participants with available data. Guideline-directed medical therapy is additionally assessed according to left ventricular ejection fraction category.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| French Overseas Territories (DOM) | – | –Adults with heart failure enrolled in the Satelia Cardio remote monitoring program and followed by one of nine participating centers located in Martinique, Guadeloupe, or La Réunion. |
| Mainland France | – | –Adults with heart failure enrolled in the Satelia Cardio remote monitoring program and followed by participating centers located in mainland France. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with heart failure enrolled in the Satelia® Cardio telemonitoring program in France between 28 August 2018 and 6 July 2026. Participants were classified according to the location of the center responsible for their follow-up as either the French overseas departments cohort, comprising Martinique, Guadeloupe, and La Réunion, or the mainland France cohort.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Diagnosis of heart failure.
- Enrollment in the Satelia® Cardio telemonitoring program between 28 August 2018 and 6 July 2026.
- Follow-up by a participating center in either the French overseas departments of Martinique, Guadeloupe, or La Réunion, or mainland France.
Key exclusion criteria (1 listed)
- Follow-up center could not be determined from the extracted data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Profile of Participants by Geographic Cohort
Time frame: At enrollment in the Satelia Cardio remote monitoring program
Demographic and clinical characteristics of participants in the French overseas departments and mainland France cohorts, including age, sex, New York Heart Association functional class, left ventricular ejection fraction category, heart failure etiology, cardiovascular risk factors, and comorbidities.
Telemonitoring Organization and Engagement by Geographic Cohort
Time frame: From enrollment through the end of follow-up, up to 6 July 2026.
Telemonitoring organization and engagement, including monitoring mode, monitoring frequency, questionnaire adherence, triggered clinical alerts, and duration of follow-up, compared between the French overseas departments and mainland France cohorts.
Guideline-Directed Medical Therapy Exposure by Geographic Cohort
Time frame: During telemonitoring follow-up, through 6 July 2026
Proportion of participants with recorded exposure to beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors. Exposure to a therapeutic class is defined as at least one prescription for that class recorded at any time during follow-up. Three-class and four-class GDMT are also assessed, with four-class GDMT defined as recorded exposure to beta-blocker, renin-angiotensin system inhibition (ARNI, ACEi, or ARB), MRA, and SGLT2i; concurrent use at a single time point is not required.
Retention Under Telemonitoring and Reasons for Discontinuation
Time frame: Status at the end of follow-up, through 6 July 2026.
Proportion of participants remaining under telemonitoring at the end of follow-up and distribution of recorded reasons for discontinuation, including death, patient-initiated discontinuation, and care-team-initiated discontinuation.
1 secondary outcome
Guideline-Directed Medical Therapy by Left Ventricular Ejection Fraction Category
Time frame: During telemonitoring follow-up, through 6 July 2026.
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 2 Oct 2026.
- Background: PubMed 39807086Girerd N, Barbet V, Seronde MF, Benchimol H, Jagu A, Tartiere JM, Hanon O, Picard F, Lafitte S, Lemaitre M, Pages N, Nisse-Durgeat S, Jourdain P. Association of a remote monitoring programme with all-cause mortality and hospitalizations in patients with heart failure: National-scale, real-world evidence from a 3-year propensity score analysis of the TELESAT-HF study. Eur J Heart Fail. 2025 Sep;27(9):1658-1669. doi: 10.1002/ejhf.3563. Epub 2025 Jan 14.
- Background: 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: No. Individual participant-level data will not be made publicly available because the study is based on pseudonymised routine-care health data subject to applicable data-protection and governance requirements.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 2 Oct 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?
Clinical Profile of Participants by Geographic Cohort (time frame: At enrollment in the Satelia Cardio remote monitoring program). The study lists 4 primary outcomes in all. 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 NCT07855471, which also lists 2 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 2 Oct 2026.