Prognostic Impact of Diabetes and Weight Variability in Telemonitored Heart Failure

NCT07561866 | Completed

• 1 other identifier: DM-HF-Tele
• Study Type: observational
• Target: 16,556
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Heart Failure; Diabetes (DM); Type 2 Diabetes

Keywords

Heart failure; Type 2 diabetes mellitus; Multimorbidity; Weight variability; Telemonitoring; Remote patient monitoring; Survival

Outcome Measures

Primary Outcomes (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.

  From enrolment up to 3 years of follow-up

Secondary Outcomes (3)

• All-Cause Mortality

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

• Association Between Comorbidity Burden and All-Cause Mortality

  From enrolment up to 3 years of follow-up

• Association Between Short-Term Weight Variability and All-Cause Mortality

  From enrolment up to 3 years of follow-up

Study Arms (1)

Heart Failure Telemonitoring Cohort

Adults 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.

Other: Diabetes Status; Other: Comorbidity Burden; Other: Weight variability

Interventions

Diabetes Status OTHER

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

Heart Failure Telemonitoring Cohort

Comorbidity Burden OTHER

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

Heart Failure Telemonitoring Cohort

Weight variability OTHER

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

Heart Failure Telemonitoring 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

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Satelia: lead

Study Sites (1)

Satelia

Bordeaux, 33000, France

Location

Related Publications (6)

• 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.

  PMID: 29520964 BACKGROUND

• 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.

  PMID: 21080835 BACKGROUND

• 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.

  PMID: 28785469 BACKGROUND

• 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.

  PMID: 31497854 BACKGROUND

• 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.

  PMID: 32846201 BACKGROUND

• 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.

  PMID: 16249546 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Heart Failure

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Paul Valensi

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: September 3, 2018
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)