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临床试验/NCT04570098
NCT04570098已完成不适用

Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 1,016 人开始时间: 2020年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,016
试验地点
1
主要终点
Overall mortality

研究概览

简要总结

The present study includes patients with tricuspid regurgitation and heart failure diagnosed with echocardiography. The aim is to evaluate the physical performance of patients with tricuspid regurgitation and heart failure, to observe the course of the diseases and to allow a better understanding of new therapy options.

详细描述

Moderate to severe tricuspid regurgitation (TR) is a frequent result of left heart failure causing a limiting prognosis. The new interventional therapies have given more relevance to the questions of the prognostic significance of severe TR in the various heart failure entities.

Important but currently unanswered questions for the establishment of successful, interventional therapies of TR are:

  1. What effect does TR have on patients with heart failure?
  2. Which patients at which stage of the disease benefit from interventional TR-therapies? In order to answer these questions, the aim of the study is to prospectively record the prevalence of TR (including quantification) in all heart failure patients at the Charité, followed by long-term observation to assess its prognostic relevance.

In addition to answering the above-mentioned questions, the project will allow a central registration of all symptomatic heart failure patients. A comparative outcome analysis per propensity score matching with the untreated patients of the registry would allow to give first considerations which patients are ideal candidates for interventional therapies.

Primary endpoint: death Secondary endpoint: hospitalization due to cardiac decompensation, exercise capacity according to NYHA classification

研究设计

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

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with transthoracic echocardiography (TTE) and heart failure
  • Reported heart failure symptoms within the last two years
  • >18 years
  • Written, documented consent

排除标准

  • Patients in care or unable to consent

结局指标

主要结局

Overall mortality

时间窗: 24 months after enrolment

Overall mortality after 24 months (number of deceased patients)

次要结局

  • hospitalization due to cardiac decompensation(24 months after enrolment)
  • exercise capacity according to NYHA classification(24 months after enrolment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Henryk Dreger

Professor

Charite University, Berlin, Germany

研究点 (1)

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