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临床试验/NCT02375399
NCT02375399终止不适用

New Approaches to Echocardiography Assessment of Cardiac Dyssynchrony: Relevance Concerning Response Rate to Cardiac Resynchronization Therapy

Heidelberg University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
1
主要终点
2D strain

研究概览

简要总结

Echocardiography parameters for cardiac dyssynchrony had no predictive value in current multicentric prospective studies concerning cardiac resynchronization therapy. Comprehensive echocardiography and new parameters as 2D and 3D strain, as well as 3D echo have been analyzed, but their definite value has not been proven yet.

详细描述

In patients with severe heart failure, delays in the conduction system can result in asynchronous contraction impairing cardiac function. By implantation of pacemaker systems with three leads located in atrium, right ventricle and coronary sinus, tracing back this deranged contraction closer to the physiological excitation propagation is aimed (cardial resynchronization therapy [CRT]). Despite patient selection according to the guidelines nearly one-third of the patients do not profit, neither clinically nor echocardiographically, from an implanted CRT-device. In addition, recent studies have shown that no reliable prediction may be achieved with the known echocardiographic parameters of dyssynchrony, regarding the response to such therapy. The aim of this study is therefore to assess new echocardiographic parameters, which may allow to better predict CRT response.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • congestive heart failure, dilated cardiomyopathy, indication for implantation of a CRT-device according to the European Society of Cardiology (ESC)

排除标准

  • persons who are incapable of giving informed consent
  • acute heart attack
  • arrhythmia during the examination (such as atrial fibrillation and frequent VES)
  • state after STEMI with an extended scar
  • inotropic drug therapy
  • pre-existing permanent pacemaker stimulation

结局指标

主要结局

2D strain

时间窗: 12 months

offline analysis of echocardiography data

3D echocardiography

时间窗: 12 months

offline analysis of echocardiography data

m-mode echocardiography

时间窗: 12 months

offline analysis of echocardiography data

次要结局

  • six-min walk test(12 months)
  • LV EF(12 month)
  • NYHA(12 months)
  • NT-proBNP(12 months)

研究者

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

Mathias Konstandin

M.D.

Heidelberg University

研究点 (1)

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