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Clinical Trials/NCT01230294
NCT01230294
Unknown
Not Applicable

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

Heidelberg University1 site in 1 country150 target enrollmentOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Right Ventricular Dysfunction
Sponsor
Heidelberg University
Enrollment
150
Locations
1
Primary Endpoint
3D-volumetry of the right ventricle
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
December 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Derliz Mereles

Derliz Mereles, M.D.

Heidelberg University

Eligibility Criteria

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

Outcomes

Primary Outcomes

3D-volumetry of the right ventricle

Time Frame: 2 years

2D strain of the right ventricle

Time Frame: 2 years

Secondary Outcomes

  • 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)

Study Sites (1)

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