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临床试验/NCT07561866
NCT07561866已完成不适用

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

Satelia1 个研究点 分布在 1 个国家目标入组 16,556 人开始时间: 2018年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16,556
试验地点
1
主要终点
Association Between Diabetes Status and All-Cause Mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Diabetes Status (Other)

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.

干预措施: Comorbidity Burden (Other)

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.

干预措施: Weight variability (Other)

结局指标

主要结局

Association Between Diabetes Status and All-Cause Mortality

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Satelia
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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