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临床试验/NCT01834833
NCT01834833已完成不适用

Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient.

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2013年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
326
试验地点
2
主要终点
days alive out of hospital 6 months post discharge

研究概览

简要总结

Evaluate the benefit of systematic appointment with a cardiologist a week after hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of hospital during 6 months

详细描述

Background: the risk for rehospitalisation is very high after hospitalisation for acute heart failure. Aim: evaluate the benefit of a consultation with a cardiologist, including echocardiography and education of the patient, between 7 and 15 days after discharge, in high risk patients, identified with BNP or incomplete therapy. Parallel randomised study. The main endpoint is the number of day alive out of hospital during the 6 months post discharge; statistics intention to treat comparison of the number of days alive out of hospital in the group with consultation compared with the group without consultation. Recruitment 3 years and 4 months, follow-up 6 months. Patients included have been hospitalised in hospital BICHAT 75018 Paris, France. Financing is by the ministry of health (PHRQHOS)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

研究组 & 干预措施

Control

No Intervention

usual care without systematic cardiology evaluation between 1 and 2 weeks

Follow-up

Experimental

Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary

干预措施: Follow-up (Other)

结局指标

主要结局

days alive out of hospital 6 months post discharge

时间窗: 6 months

次要结局

  • QOL at 6 months(6 months)
  • number of patients having an optimal treatment at 6 months(6 months)
  • mortality at 3 and 6 months(3 and 6 months)
  • rehospitalisation rate at 6 months(6 months)
  • autoevaluation of improvement/alteration of the patient state at 6 months(6 months)
  • number of patients receiving a ACEI at 6 months(6 months)
  • number of patients receiving beta-blocker at 6 months(6 months)
  • number of patients receiving beta-blocker at 3 months(3 months)
  • number of patients receiving a ACEI at 3 months(3 months)
  • QOL at 3 months(3 months)
  • autoevaluation of improvement/alteration of the patient state at 3 months(3 months)
  • number of patients having an optimal treatment at 3 months(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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