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临床试验/NCT03050112
NCT03050112已完成不适用

Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.

Pierre Wauthy1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年2月14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
发起方
入组人数
250
试验地点
1
主要终点
MacNew questionnaire

研究概览

简要总结

Adults with a congenital heart disease, having undergone a surgical intervention or a re-do surgery in adulthood, are a growing group of subjects in the general population. This increase is explained by improved medical and surgical techniques, with a better survival rate as outcome.

There is nowadays a growing interest in the quality of life of this group of subjects. However, studies give contradictory results. This can be explained on one hand by the vast majority of pathologies within this population, and on the other hand by the absence of a cardio-specific tool for quality of life measurement.

The MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life based on the exploration of three domains: physical, emotional and social.

The aim of this study is:

  • to evaluate the quality of life of these patients, by using the MacNew questionnaire
  • to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up
  • to assess the mortality within this group of patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having had surgery in adulthood for a congenital heart disease, at the Brugmann University Hospital. The group consists in patients aged 16 years or older, having had surgery between 01/01/1998 and 31/12/2015

排除标准

  • 未提供

研究组 & 干预措施

Congenital cardiopathy

Experimental

Patients having had surgery in adulthood for a congenital heart disease, at the Brugmann University Hospital. The group consists in patients aged 16 years or older, having had surgery between 01/01/1998 and 31/12/2015.

干预措施: MacNew questionnaire (Other)

结局指标

主要结局

MacNew questionnaire

时间窗: 30 minutes

Quality of life assessment

次要结局

未报告次要终点

研究者

发起方
Pierre Wauthy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pierre Wauthy

Head of clinic

Brugmann University Hospital

研究点 (1)

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