New Echocardiographic Methods for Right Ventricular Function. (NEW-RV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01230294|
Recruitment Status : Unknown
Verified November 2016 by Derliz Mereles, Heidelberg University.
Recruitment status was: Active, not recruiting
First Posted : October 29, 2010
Last Update Posted : November 8, 2016
|Condition or disease|
|Right Ventricular Dysfunction|
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 Type :||Observational|
|Estimated Enrollment :||150 participants|
|Observational Model:||Case Control|
|Official Title:||Evaluation of New Echocardiographic Methods for Measurement of Right Ventricular Function.|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2015|
participants without structural heart disease
patients with chronic heart failure of the left ventricle affecting the right heart
patients with pulmonary arterial hypertension without left ventricular dysfunction
- 3D-volumetry of the right ventricle [ Time Frame: 2 years ]
- 2D strain of the right ventricle [ Time Frame: 2 years ]
- pulmonary artery systolic pressure (PASP) [ Time Frame: 2 years ]standard value: ≤ 30 mmHg
- tricuspid annular plane systolic excursion (TAPSE) [ Time Frame: 2 years ]standard value: ≥ 20 mm
- tricuspid annular systolic velocity (TASV) [ Time Frame: 2 years ]standard value: ≥ 20cm/s
- Tei-index (myocardial performance index) [ Time Frame: 2 years ]standard value: ≥ 0,5
- LV-eccentricity-index (Lei-index) [ Time Frame: 2 years ]standard value: ≥ 1,0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230294
|University of Heidelberg|
|Heidelberg, Baden-Wuerttemberg, Germany, 69120|
|Principal Investigator:||Sebastian Greiner, M.D.||Heidelberg University|
|Principal Investigator:||Derliz Mereles, M.D.||Heidelberg University|