New Echocardiographic Methods for Right Ventricular Function.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Right Ventricular Dysfunction

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br>participants without structural heart disease | |
| CHF<br>patients with chronic heart failure of the left ventricle affecting the right heart | |
| PAH<br>patients with pulmonary arterial hypertension without left ventricular dysfunction | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D-volumetry of the right ventricle |  | 2 years | 
| 2D strain of the right ventricle |  | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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echocardiography of the right heart, 3D 4D echocardiography, strain measurement, chronic heart failure, pulmonary hypertension