New Echocardiographic Methods for Right Ventricular Function.

• Conditions: Right Ventricular Dysfunction

• Registration Number: NCT01230294
• Lead Sponsor: Heidelberg University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-10-29
• Primary Completion: 2015-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-05
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3D-volumetry of the right ventricle	2 years
2D strain of the right ventricle	2 years

Secondary Outcome Measures

Name	Time	Method
pulmonary artery systolic pressure (PASP)	2 years	standard value: ≤ 30 mmHg
tricuspid annular systolic velocity (TASV)	2 years	standard value: ≥ 20cm/s
LV-eccentricity-index (Lei-index)	2 years	standard value: ≥ 1,0
tricuspid annular plane systolic excursion (TAPSE)	2 years	standard value: ≥ 20 mm
Tei-index (myocardial performance index)	2 years	standard value: ≥ 0,5

Trial Locations

Locations (1)

University of Heidelberg; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany