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Chronic Heart FailureDM-HF-TeleNCT07561866

Prognostic Impact of Diabetes and Weight Variability in Telemonitored Heart Failure

An observational study of Chronic Heart Failure and Type 2 Diabetes, run by Satelia at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This observational cohort study evaluates the prognostic impact of diabetes, comorbidity burden, and short-term weight variability among adults with chronic heart failure enrolled in a nationwide remote patient monitoring program in France. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Diabetes Status, Comorbidity Burden and Weight variability
How many people
16,556 participants
Where
1 siteFrance
Study dates
3 Sep 2018to 3 Apr 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: he study population consists of adults with chronic heart failure in France who were enrolled in a nationwide remote patient monitoring program between September 2018 and April 2024 as part of routine clinical care. Patients entered the program following hospitalization for heart failure or in the ambulatory setting based on clinical criteria consistent with heart failure management. The cohort includes individuals with and without diabetes and 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 September 3, 2018, and April 3, 2024
  • Availability of baseline clinical data including diabetes status

Who cannot join

  • Missing baseline information on diabetes status
  • Missing follow-up data for survival status

Trial locations and contacts

1 site in 1 country.

France1 site

  • Satelia

    Bordeaux, 33000

Other trials in France

About this study

Official title: Impact of Diabetes, Short-term Weight Variability, Heart Failure Etiologies and Other Comorbidities on Survival in a National Telemonitored Heart Failure Cohort

This observational cohort study evaluates the prognostic impact of diabetes, comorbidity burden, and short-term weight variability among adults with chronic heart failure enrolled in a nationwide remote patient monitoring program in France. Patients were enrolled between September 3 2018 and April 3 2024 as part of routine heart failure care. Baseline demographic, clinical, and treatment data, along with weight measurements collected through telemonitoring, were analyzed. The study aims to assess associations between diabetes status, multimorbidity, and weight variability with survival outcomes using retrospective data from the program database. No study-mandated interventions were performed.

Read the detailed description

This retrospective, multicenter observational cohort study was conducted using data from a nationwide heart failure remote patient monitoring program in France. The program supports routine clinical management of patients with chronic heart failure through digital symptom and weight monitoring, automated alerts, and coordination with healthcare providers.

The study includes adult patients enrolled between September 2018 and April 2024. Clinical characteristics recorded at enrollment were extracted from the program database, including demographics, heart failure severity indicators, comorbid conditions, and treatment information. Repeated weight measurements obtained during telemonitoring were used to calculate short-term weight variability as a marker of dynamic physiological status.

The primary objective is to evaluate the association between diabetes and survival in patients with chronic heart failure. Secondary objectives include assessment of the impact of overall comorbidity burden and short-term weight variability on survival, as well as exploration of interactions between diabetes, age, and multimorbidity.

All treatments and monitoring were part of routine care. No interventions were assigned by the study protocol. Statistical analyses include survival modeling and multivariable adjustment to identify independent predictors of outcomes.

Being tested
Diabetes Status, Comorbidity Burden, Weight variability
Keywords
Heart failure, Type 2 diabetes mellitus, Multimorbidity, Weight variability, Telemonitoring, Remote patient monitoring, Survival
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes StatusOther

    Presence or absence of diabetes mellitus recorded at enrolment as part of routine clinical assessment.

  • Comorbidity BurdenOther

    Number of chronic comorbid conditions recorded at enrollment, used as a measure of multimorbidity.

  • Weight variabilityOther

    Short-term variability in body weight calculated from repeated weight measurements collected during routine telemonitoring, used as a marker of dynamic physiological status.

Study groups in NCT07561866
Study groupRoleWhat they receive
Heart Failure Telemonitoring CohortAdults with chronic heart failure enrolled in a nationwide remote patient monitoring program in France between September 2018 and April 2024. Clinical characteristics at enrolment and weight measurements collected during routine telemonitoring were analyzed to evaluate associations between diabetes, comorbidity burden, weight variability, and survival outcomes in routine care.
Receives: Other: Diabetes Status; Other: Comorbidity Burden; Other: Weight variability

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association Between Diabetes Status and All-Cause Mortality

    Relationship between the presence of diabetes mellitus at enrolment and subsequent risk of death, evaluated using multivariable survival analysis.

    Measured: From enrolment up to 3 years of follow-up

Secondary outcomes (3)

  1. All-Cause Mortality

    Time from enrolment to death from any cause, assessed using follow-up data collected during routine care within the remote monitoring program.

    Measured: From enrolment in the remote monitoring program up to 3 years of follow-up

  2. Association Between Comorbidity Burden and All-Cause Mortality

    Association between the number of chronic comorbid conditions at enrolment and risk of death during follow-up.

    Measured: From enrolment up to 3 years of follow-up

  3. Association Between Short-Term Weight Variability and All-Cause Mortality

    Relationship between short-term variability in body weight measured during telemonitoring and subsequent risk of death

    Measured: From enrolment up to 3 years of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start3 Sep 2018
  3. Primary completion3 Apr 2024
  4. Study completion3 Apr 2024

Resources

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
16,556 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07561866
Sponsor's protocol ID
DM-HF-Tele
Acronym
DM-HF-Tele
Status last verified
Apr 2026
First submitted
24 Apr 2026
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data collected for this study are derived from a national telemonitoring program and contain sensitive health information. Data sharing is restricted due to patient privacy protections and applicable European data protection regulations (GDPR). Access to de-identified data may be considered upon reasonable request and subject to appropriate data protection agreements and regulatory approval.

Publications

  • Seferovic PM, Petrie MC, Filippatos GS, Anker SD, Rosano G, Bauersachs J, Paulus WJ, Komajda M, Cosentino F, de Boer RA, Farmakis D, Doehner W, Lambrinou E, Lopatin Y, Piepoli MF, Theodorakis MJ, Wiggers H, Lekakis J, Mebazaa A, Mamas MA, Tschope C, Hoes AW, Seferovic JP, Logue J, McDonagh T, Riley JP, Milinkovic I, Polovina M, van Veldhuisen DJ, Lainscak M, Maggioni AP, Ruschitzka F, McMurray JJV. Type 2 diabetes mellitus and heart failure: a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2018 May;20(5):853-872. doi: 10.1002/ejhf.1170. Epub 2018 Mar 8.

    PubMed 29520964

  • Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.

    PubMed 21080835

  • Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.

    PubMed 28785469

  • Cosentino F, Grant PJ, Aboyans V, Bailey CJ, Ceriello A, Delgado V, Federici M, Filippatos G, Grobbee DE, Hansen TB, Huikuri HV, Johansson I, Juni P, Lettino M, Marx N, Mellbin LG, Ostgren CJ, Rocca B, Roffi M, Sattar N, Seferovic PM, Sousa-Uva M, Valensi P, Wheeler DC; ESC Scientific Document Group. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020 Jan 7;41(2):255-323. doi: 10.1093/eurheartj/ehz486. No abstract available.

    PubMed 31497854

  • Valensi P, Henry P, Boccara F, Cosson E, Prevost G, Emmerich J, Ernande L, Marcadet D, Mousseaux E, Rouzet F, Sultan A, Ferrieres J, Verges B, Van Belle E. Risk stratification and screening for coronary artery disease in asymptomatic patients with diabetes mellitus: Position paper of the French Society of Cardiology and the French-speaking Society of Diabetology. Diabetes Metab. 2021 Mar;47(2):101185. doi: 10.1016/j.diabet.2020.08.002. Epub 2020 Aug 23. No abstract available.

    PubMed 32846201

  • Valensi P, Paries J, Brulport-Cerisier V, Torremocha F, Sachs RN, Vanzetto G, Cosson E, Lormeau B, Attali JR, Marechaud R, Estour B, Halimi S. Predictive value of silent myocardial ischemia for cardiac events in diabetic patients: influence of age in a French multicenter study. Diabetes Care. 2005 Nov;28(11):2722-7. doi: 10.2337/diacare.28.11.2722.

    PubMed 16249546

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Heart Failure and Type 2 Diabetes, 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 2 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 1 May 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?

Association Between Diabetes Status and All-Cause Mortality (time frame: From enrolment up to 3 years of follow-up). 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 NCT07561866, which also lists 6 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 1 May 2026.

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