跳至主要内容
临床试验/NCT02986633
NCT02986633招募中不适用

Prediction of Response to Cardiac Resynchronization Therapy by New Echocardiographic Methods

Lille Catholic University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Changes in left ventricular end-systolic volume measured by echocardiography

研究概览

简要总结

The present observational prospective study aims at identifying echocardiographic parameters (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV) ascertained using new methods of echocardiography including speckle tracking strain) that are linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT

详细描述

The Cardiac Resynchronization Therapy (CRT) reduces mortality of patients with heart failure and reduced LV ejection fraction. The clinical benefit of CRT is mediated by LV reverse remodelling (decrease in LV end-systolic volume over time). However, 30 to 50 % of these patients will not experience LV reverse remodelling following CRT.

Classical parameters of dyssynchrony obtained by conventional methods of echocardiography (including doppler tissue imaging) have a limited value in predicting CRT response. Meanwhile, patients with a Left Bundle Branch Block (LBBB) on the electrocardiogram experience more frequently LV reverse remodelling than those without a LBBB.

LBBB is responsible for specific LV contractile abnormalities that can be identified by speckle tracking strain echocardiography (early septal contraction, stretching of late contraction of the postero-lateral wall). The predictive value of these abnormalities remains to be studied.

Thus, it has been hypothesised that these LBBB-related contractile abnormalities may be independent predictors of LV reverse remodelling and outcome following CRT.

The present observational prospective study aims at identifying echocardiographic parameters (based on the LBBB-like contraction of the LV ascertained using new methods of echocardiography including speckle tracking strain) that are linked to CRT response and a better outcome following CRT.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Heart failure with left ventricular ejection fraction less than 35 %
  • QRS duration over than 120 ms
  • Clinical indication for CRT

排除标准

  • Rythmologic indication of CRT for atrial fibrillation control
  • Rythmologic indication of CRT for left ventricular ejection fraction between 35% and 45%

结局指标

主要结局

Changes in left ventricular end-systolic volume measured by echocardiography

时间窗: 9 months after implantation

次要结局

  • Changes in left ventricular longitudinal strain measured by echocardiography(9 months after implantation)
  • re-hospitalisation rate(2, 4, 6, 8 and 10 years after implantation)
  • Death rate(2, 4, 6, 8 and 10 years after implantation)
  • Changes in left ventricular ejection fraction measured by echocardiography(9 months after implantation)
  • Changes in left ventricular end-diastolic volume measured by echocardiography(9 months after implantation)

研究者

发起方
Lille Catholic University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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