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临床试验/NCT01230294
NCT01230294Unknown不适用

Evaluation of New Echocardiographic Methods for Measurement of Right Ventricular Function.

Heidelberg University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
3D-volumetry of the right ventricle

研究概览

简要总结

Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function .

详细描述

Studies of the last years revealed that the right ventricular function is an important predictive value for the survival of patients with congenital heart disease, pulmonary hypertension or chronic heart failure. In 2006 the National Heart, Lung and Blood Institute has pronounced the right ventricular dysfunction including the non-invasive assessment of the right ventricular function as preferential aim of cardiovascular research.

Many parameters are used to describe right ventricular dysfunction, but none of these has a comparable significance like the left ventricular ejection fraction. Because of the limitation of each right ventricular parameter the stepwise combination of these parameters is used to describe right ventricular function what frequently results in further problems, especially in comparison of long-term controls.

Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function. The study is carried out as prospective, monocentric trial at the Department of Cardiology of the University Hospital of Heidelberg. Three different groups are set up for the assessment of the right ventricular function: patients with pulmonary arterial hypertension, patients with chronic heart failure of the left ventricle affecting the right heart and patients without structural heart disease who underwent an echocardiographic examination for other reasons (control group).

All participants are re-examined in constant intervals as clinically indicated.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • persons of 18 years and older who receive a transthoracic echocardiography at our department
  • written consent

排除标准

  • present atrial fibrillation/flutter
  • permanent pacemaker rhythm
  • moderate/severe valvular heart disease
  • pregnancy

结局指标

主要结局

3D-volumetry of the right ventricle

时间窗: 2 years

2D strain of the right ventricle

时间窗: 2 years

次要结局

  • pulmonary artery systolic pressure (PASP)(2 years)
  • tricuspid annular systolic velocity (TASV)(2 years)
  • LV-eccentricity-index (Lei-index)(2 years)
  • tricuspid annular plane systolic excursion (TAPSE)(2 years)
  • Tei-index (myocardial performance index)(2 years)

研究者

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

Derliz Mereles

Derliz Mereles, M.D.

Heidelberg University

研究点 (1)

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