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NCT Number: NCT07561866

Prognostic Impact of Diabetes and Weight Variability in Telemonitored Heart Failure

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.

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Key information

Conditions

Chronic Heart Failure Cardiovascular Diseases Diabetes (DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Satelia

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes Status

Other

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

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.

Primary outcomes

  1. Association Between Diabetes Status and All-Cause Mortality

    Time frame: 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 outcomes

  1. All-Cause Mortality

    Time frame: 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.

  2. Association Between Comorbidity Burden and All-Cause Mortality

    Time frame: 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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Satelia

Industry

Registry information

Official study title

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

Acronym: DM-HF-Tele

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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