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临床试验/NCT03870516
NCT03870516Unknown不适用

Assessment of Subclinical Left Atrial and Left Ventricular Dysfunction by Speckle Tracking Echocardiography in Severe Asymptomatic Rheumatic Mitral Regurgitation and Its Role in Predicting Outcome After Valve Replacement Compared to Guideline Parameters

Assiut University0 个研究点目标入组 100 人开始时间: 2021年9月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Recovery of left atrial functions (conduit, reservoir and booster contractile functions) and left ventricular function (global longitudinal strain) by speckle tracking echocardiography after mitral valve replacement

研究概览

简要总结

The study aims to analyze the role of left ventricular and left atrial functional parameters by speckle tracking echocardiography in predicting outcome after mitral valve replacement and targeting for early intervention compared to guideline parameters.

详细描述

Without surgical treatment, the 10-year morbidity and mortality for patients with severe mitral regurgitation can be as high as 90%.

In contrast, with successful surgical correction of mitral regurgitation before the appearance of symptoms, patients may have life expectancies similar to that of the general population.

According to European recommendations, mitral valve replacement must be proposed to symptomatic patients and to patients with significant left ventricular remodeling as a consequence of the severity of mitral regurgitation.

A significant decline in left ventricular function is defined, in these recommendations, echocardiographically as an left ventricular ejection fraction < 60% or an left ventricular end-systolic diameter > 45 mm.

Preoperative left ventricular systolic function and left ventricular end systolic diameter are important postoperative prognostic factors.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with rheumatic severe mitral regurgitation who will have mitral valve replacement in Assiut University Heart Hospital

排除标准

  • Degenerative mitral regurgitation, ischemic mitral regurgitation, severe rheumatic mitral regurgitation with atrial fibrillation or impaired left ventricular ejection fraction, associated mitral stenosis, or significant aortic regurgitation and ischemic heart disease.

结局指标

主要结局

Recovery of left atrial functions (conduit, reservoir and booster contractile functions) and left ventricular function (global longitudinal strain) by speckle tracking echocardiography after mitral valve replacement

时间窗: 6 months after surgery

Speckle tracking echocardiography will be performed 6 months after surgery to assess recovery of left atrial function by assessment of conduit, reservoir and booster contractile functions and left ventricular function by assessment of global longitudinal strain after mitral valve replacement

次要结局

  • Number of patients with major adverse cardiovascular events (MACE)(6 months)

研究者

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

Mohamed M. Reda Abdelaziz

physician

Assiut University

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