Chronic Heart Failure, Diabetes (DM), Type 2 Diabetes
Conditions
Keywords
Heart failure, Type 2 diabetes mellitus, Multimorbidity, Weight variability, Telemonitoring, Remote patient monitoring, Survival
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.
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.
Interventions
OTHERDiabetes Status
Presence or absence of diabetes mellitus recorded at enrolment as part of routine clinical assessment.
OTHERComorbidity Burden
Number of chronic comorbid conditions recorded at enrollment, used as a measure of multimorbidity.
OTHERWeight variability
Short-term variability in body weight calculated from repeated weight measurements collected during routine telemonitoring, used as a marker of dynamic physiological status.
Sponsors
Satelia
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Missing baseline information on diabetes status * Missing follow-up data for survival status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Diabetes Status and All-Cause Mortality | From enrolment up to 3 years of follow-up | Relationship between the presence of diabetes mellitus at enrolment and subsequent risk of death, evaluated using multivariable survival analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | From enrolment in the remote monitoring program up to 3 years of follow-up | Time from enrolment to death from any cause, assessed using follow-up data collected during routine care within the remote monitoring program. |
| Association Between Comorbidity Burden and All-Cause Mortality | From enrolment up to 3 years of follow-up | Association between the number of chronic comorbid conditions at enrolment and risk of death during follow-up. |
| Association Between Short-Term Weight Variability and All-Cause Mortality | From enrolment up to 3 years of follow-up | Relationship between short-term variability in body weight measured during telemonitoring and subsequent risk of death |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPaul Valensi
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed