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临床试验/NCT00127322
NCT00127322Unknown不适用

The Early High Risk Period for Patients With Incident Heart Failure: A Population Based Study

Royal Brompton & Harefield NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
450
试验地点
2

研究概览

简要总结

Many people with heart failure either die or are admitted to the hospital in the first few months after the condition is diagnosed. The reasons for this are currently unclear- but may be due to worsening heart failure or other medical conditions such as angina, heart attack or sudden electrical problems of the heart. The investigators propose to recruit and follow-up 450 people, with a new diagnosis of heart failure for a minimum of six months in a multi-centre observational study at two hospital sites: The Hillingdon (Uxbridge) and The Conquest (Hastings) hospitals. The total study duration will be two years. People will be recruited after a diagnosis of heart failure is made and the study will assess reasons for death or admission to hospital and the psychological impact of the condition on both patients and their carers. This is an observational study and no change will be made to patients' conventional treatment.

Hypotheses:

  1. The high mortality and hospitalisation rate in the early period after diagnosis of heart failure is related to progressive pump failure; or
  2. The high mortality in the early period after the diagnosis of heart failure is related to co-morbid events- principally major coronary events such as myocardial infarction or acute coronary syndrome.

This research should help to identify ways of improving the outlook for people with newly diagnosed heart failure. The analysis of the data generated by this study will be supervised by a statistician. Clinical and demographic data will be described using mean + standard deviation, for continuous variables, and absolute numbers and percentages for categorical variables. Group differences will be examined by t-tests for continuous variables and Chi-square (x2) test for categorical variables. Survival will be reported in terms of Kaplan-Meier curves with differences analysed by Cox proportional hazards.

研究设计

研究类型
Observational
观察模型
Defined Population
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

  • Clinical diagnosis of heart failure

排除标准

  • Under age of 18 years
  • Unable to give consent

研究者

研究点 (2)

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