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临床试验/NCT00837889
NCT00837889已完成不适用

Cognitive Impairment and Prognosis in Patients With Decompensated Heart Failure

Universität des Saarlandes2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年1月1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
入组人数
60
试验地点
2
主要终点
cognitive function in decompensated heart failure patients measured by a cognitive test battery

研究概览

简要总结

The aim of the present study is threefold: investigating 1) specific cognitive impairments in patients with congestive heart failure, 2) whether cognitive impairments in patients with decompensated heart failure improve after medical recompensation and 3) whether cognitive functioning is related to the long-term prognosis (mortality, rehospitalisation) of those patients.

详细描述

The daily routine in clinical settings often shows cognitive impairments in patients with congestive heart failure. Recent studies reported declines in cognitive functioning such as executive functions, episodic memory, perceptual speed and attention. However, less is known regarding the differential impairments of cognitive functioning in patients with decompensated heart failure.

Study objectives:

  1. Identifying specific cognitive impairments in patients with congestive heart failure compared to healthy controls
  2. Evaluating the influence of acute decompensation in congestive heart failure on cognitive functioning
  3. Investigating the effects of medical treatment on cognitive functioning in patients with decompensated heart failure
  4. Exploring long-term effects of cognitive and physiological status on hospitalisation and/or mortality

Study design:

Cognitive functions of patients with decompensated heart (NYHA III-IV) failure are compared to age and gender matched patients with congestive heart failure (NYHA III-IV) without symptoms of cardiac decompensation and with healthy controls. Decompensated patients are tested before and after medical recompensation. For matched patients and controls, the pretest-posttest timing is based on the recompensation time of the respective patient with decompensated heart failure.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • decompensated heart failure patients
  • NYHA III-IV
  • ejection fraction < 35%

排除标准

  • psychosis
  • major depression
  • reanimation (<3month)
  • patients with assist device system

研究组 & 干预措施

decompensated heart failure patients

干预措施: diuretics, inotropica (Drug)

结局指标

主要结局

cognitive function in decompensated heart failure patients measured by a cognitive test battery

时间窗: within 48h of hospitalisation

cognitive function before and after medical recompensation measured by a cognitive test battery

时间窗: individual time to recompensate

differences in cognitive performance between decompensated heart failure patients, patients with chronic heart failure and healthy controls

时间窗: 14 months (+/-2 month)

次要结局

  • long-term development of cognitive functioning in patients with heart failure after acute decompensation(3, 6, 12 and 18 months after acute decompensation)
  • all cause mortality(12 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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