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临床试验/NCT04112511
NCT04112511已完成不适用

Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

AHEPA University Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2015年3月1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
250
试验地点
1
主要终点
Implantable cardioverter defibrillator therapy

研究概览

简要总结

The purpose of the study is to investigate the potential correlations of global longitudinal strain and peak left atrial strain, measured by speckle tracking echocardiography with the severity of hypertrophic cardiomyopathy and the risk for arrhythmias.

Specifically the investigational questions are:

  1. Is there a correlation between myocardial deformation parameters of the left heart chambers with other important ultrasound parameters (eg maximal wall thickness, presence of subaortic obstruction, etc.) in patients with hypertrophic cardiomyopathy?
  2. Is there a correlation between myocardial deformation parameters of the left heart chambers and the symptomatology or functional capacity of patients with hypertrophic cardiomyopathy?
  3. Is there a correlation between the myocardial deformation parameters of the left heart chambers and the exercise capacity, as evidenced by the cardiopulmonary exercise test, in patients with hypertrophic cardiomyopathy?
  4. Is there a correlation between myocardial deformation parameters of the left heart chambers with the risk of ventricular or supraventricular arrhythmias in patients with hypertrophic cardiomyopathy?
  5. Is there a correlation between myocardial deformation parameters of the left heart chambers and risk factors for sudden death?

详细描述

Myocardial deformation parameters of the left heart chambers are of particular clinical importance because of their possible association with the severity of HCM and the presence of arrhythmias. However,current literature appears conflicting.

This is a prospective cohort study aiming to examine the echocardiographic parameters of myocardial deformation, estimated by the "speckle tracking" method, and their correlation with clinical presentation and symptomatology, other imaging parameters, exercise capacity, arrhythmias (ventricular or supraventricular) and risk factors for sudden death in patients with hypertrophic cardiomyopathy.

Although, similar efforts have been made in international literature, they are scarce and their results contradictory. The present study is the first to be performed in a Greek population, a fact that is particularly important given the genetic heterogeneity of the disease.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with diagnosed hypertrophic cardiomyopathy

排除标准

  • Concomitant severe valvular heart disease
  • Prior myocardial infarction
  • History of atrial fibrillation

结局指标

主要结局

Implantable cardioverter defibrillator therapy

时间窗: 3 years

Aproppriate Implantable cardioverter defibrillator therapy

Cardiovascular mortality

时间窗: 3 years

Death directly attributed to the primary disease

Cardiac arrest

时间窗: 3 years

Documented ventricular fibrillation or sustained ventricular tachycardia

All cause mortality

时间窗: 3 years

Death by any cause

次要结局

  • Atrial fibrillation(3 years)

研究者

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

Thomas Zegkos

Medical Doctor, Resident in Cardiology

AHEPA University Hospital

研究点 (1)

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