跳至主要内容
临床试验/NCT07278583
NCT07278583招募中不适用

Evaluation of Eligibility Criteria for Heart Failure Telemonitoring : Analysis of CARDIAUVERGNE's Cohort

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
130
试验地点
2
主要终点
Composite criterion defined by the occurrence within one year following the end of remote monitoring of either cardiovascular death or heart failure worsening (hospitalization or unscheduled visit for heart failure)

研究概览

简要总结

CARDIAUVERGNE is a heart failure telemonitoring system at Clermont-Ferrand's hospital. The aim of this study is to analyze the prognosis and evolution of patients after exclusion of telemonitoring. The patients were included from 1st January 2023 to 31st December 2024 and the monitoring was terminated for end of eligibility according to the French health authority criteria.

详细描述

After an episode of heart failure, patients have been included in a telemonitoring program in order to reduce rehospitalizations for heart failure and improve follow-up. On a daily basis, the patients weigh themselves on connected scales which enables a team of dedicated nurses to follow them closely. If need be they can call the patient, ask for a blood exam and adapt their prescription. Indeed, if remote support is insufficient, patients can be hospitalized prematurely and so decrease the duration of hospital care.

The inclusion criteria correspond to either an episode of heart failure in the last 12 months or dyspnea at least New York Heart Association (NYHA) 2 with NT-proBNP over 1000pg/mL.

The follow up is renewed every 6 months. Patients are excluded from monitoring when criteria are no longer fulfilled. As these characteristics have been chosen empirically, our aim is to see if patients no longer presenting these standards have indeed a low chance of bad evolution.

Information is gathered from their medical record at inclusion, exclusion and 1 year after exclusion. A short phone call is made after 1 year of exclusion, to appreciate their evolution and gather information concerning their symptoms, treatments ...

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

  • able to read and understand french
  • included in CARDIAUVERGNE telemonitoring program from 1st january 2023 to 31st december 2024 such as defined by the french health authorithy criteria (heart failure within 12 months or dyspnea at least NYHA 2 associated with NTproBNP of at least 1000pg/mL) and excluded by medical decision as no longer presenting eligibillity criteria

排除标准

  • Patients leaving telemonitoring for other reasons (choice, death, medical reason, relocation, inobservance)

结局指标

主要结局

Composite criterion defined by the occurrence within one year following the end of remote monitoring of either cardiovascular death or heart failure worsening (hospitalization or unscheduled visit for heart failure)

时间窗: From telemonitoring exclusion up to a year after

次要结局

  • Determination of potential patient profiles more suitable to discontinue remote monitoring(From inclusion up to a year after telemonitoring exclusion)
  • Natriuretic peptides, NTproBNP, evolution(From inclusion until a year after exclusion)
  • Number of patients that could theoretically be re-included during follow up(From telemonitoring exclusion up to a year after)
  • Determination of potential patient profiles more suitable to discontinue remote monitoring(From inclusion up to a year after telemonitoring exclusion)
  • Amount of medical appointments(From telemonitoring exclusion up to a year after)
  • Natriuretic peptides evolution(From inclusion until a year after exclusion)
  • Amount of theoretically possible re-included patients during follow up(From telemonitoring exclusion up to a year after)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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