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临床试验/NCT02880358
NCT02880358Unknown不适用

Epidemiology and Prognostic of the Acute Heart Failure in Northeast of France

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,500
试验地点
1
主要终点
Incidence of Acute Heart Failure

研究概览

简要总结

EPICAL 2 (Epidemiology and prognostic of the Acute Heart Failure) is an epidemiological, observational, prospective and multicenter study. This study includes at first an exhaustive recording of the cases on a geographic area at East of France, then the recorded patients are followed up in a cohort at least 3 years. This study follows the experiences of the EPICAL study led by our team.

Main objective: To describe the characteristics of the patients affected by acute heart failure and to identify prognostic factors, in particular related to care. More exactly :

  • To describe the sociodemographic, clinical, biological and therapeutic characteristics of the patients presenting an acute heart failure during hospitalisation and living at East of France ;
  • To study the short and medium-term morbi-mortality of these patients, and identify the main factors determining the prognosis for survival ;
  • To evaluate the prognostic impact of the intra and extra-hospital care ;
  • To identify the evolution of the care's practices of the decompensated heart failure since the EPICAL study (15 years) and their influence on the prognosis of the disease.

Secondary objective: to constitute a biological collection of serum, plasma and urine of patients' sample presenting an acute heart failure.

详细描述

Criteria of inclusion:

  • Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation in the intensive care, cardiology or geriatrics departments of the hospitals of Northeast of France during one year
  • Patients died in emergencies or during the transfer, with a diagnosis of acute heart failure.

Acute heart failure includes decompensation of chronic heart failure, advanced stage of the heart failure, acute oedema of the lung and cardiogenic shock. According to the data of registers, the incidence of the acute heart failure in approximately 2,5 cases per 1000 adults per year, the expected sample size amounts to 2500 eligible patients over 1 year.

Data collection: the doctors declare the Acute Heart Failure of their departments. The technicians of clinical research collect the data concerning the sociodemographic, clinical, biological and therapeutic characteristics of the inclusive patients on arrival at the hospital, during the hospitalisation and at the exit. The biological takings are made for the patients having given their consent before the exit of the hospitalization. The patients are followed up during 3 years.

研究设计

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

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of Acute Heart Failure

时间窗: Inclusion

次要结局

  • Morbi-mortality of patients presenting an acute heart failure(Inclusion, 6 month, 1, 2 and 3 years after acute heart failure)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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