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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Status | Other | Presence or absence of diabetes mellitus recorded at enrolment as part of routine clinical assessment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrolment in the remote monitoring program up to 3 years of follow-up |
| Association Between Comorbidity Burden and All-Cause Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Paul Valensi | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satelia | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29520964 | Background | 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. | |
| 21080835 |
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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.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Comorbidity Burden | Other | Number of chronic comorbid conditions recorded at enrollment, used as a measure of multimorbidity. |
|
| 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. |
|
Association between the number of chronic comorbid conditions at enrolment and risk of death during follow-up. |
| From enrolment up to 3 years of follow-up |
| 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 | From enrolment up to 3 years of follow-up |
| 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. |
| 28785469 | 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. |
| 31497854 | 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. |
| 32846201 | 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. |
| 16249546 | 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. |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |