New Echocardiographic Methods for Right Ventricular Function.

Right Ventricular Dysfunction Clinical Trial

— NEW-RV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01230294
• Other study ID #: S275-2010
• Status: Active, not recruiting
• Phase: N/A
• First received: October 28, 2010
• Last updated: November 5, 2016
• Start date: October 2010

Study information

• Verified date: November 2016
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Greiner S, André F, Heimisch M, Hess A, Steen H, Katus HA, Mereles D. Non-invasive quantification of right ventricular systolic function by echocardiography: a new semi-automated approach. Clin Res Cardiol. 2013 Mar;102(3):229-35. doi: 10.1007/s00392-012- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D-volumetry of the right ventricle		2 years	No
Primary	2D strain of the right ventricle		2 years	No
Secondary	pulmonary artery systolic pressure (PASP)	standard value: = 30 mmHg	2 years	No
Secondary	tricuspid annular plane systolic excursion (TAPSE)	standard value: = 20 mm	2 years	No
Secondary	tricuspid annular systolic velocity (TASV)	standard value: = 20cm/s	2 years	No
Secondary	Tei-index (myocardial performance index)	standard value: = 0,5	2 years	No
Secondary	LV-eccentricity-index (Lei-index)	standard value: = 1,0	2 years	No