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New Echocardiographic Methods for Right Ventricular Function. (NEW-RV)

This study is currently recruiting participants.
Verified January 2013 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Derliz Mereles, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01230294
First received: October 28, 2010
Last updated: January 29, 2013
Last verified: January 2013
History of Changes

October 28, 2010
January 29, 2013
October 2010
June 2013   (final data collection date for primary outcome measure)
  • 3D-volumetry of the right ventricle [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 2D strain of the right ventricle [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01230294 on ClinicalTrials.gov Archive Site
  • pulmonary artery systolic pressure (PASP) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    standard value: ≤ 30 mmHg
  • tricuspid annular plane systolic excursion (TAPSE) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    standard value: ≥ 20 mm
  • tricuspid annular systolic velocity (TASV) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    standard value: ≥ 20cm/s
  • Tei-index (myocardial performance index) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    standard value: ≥ 0,5
  • LV-eccentricity-index (Lei-index) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    standard value: ≥ 1,0
Same as current
Not Provided
Not Provided
 
New Echocardiographic Methods for Right Ventricular Function.
Evaluation of New Echocardiographic Methods for Measurement of Right Ventricular Function.

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

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
  • patients with pulmonary aterial hypertension
  • patients with chronic heart failure of the left ventricle affecting the right heart
  • patients without structural heart disease who underwent an echocardiographic examination for other reasons (control group)
Right Ventricular Dysfunction
Not Provided
  • control
    participants without structural heart disease
  • CHF
    patients with chronic heart failure of the left ventricle affecting the right heart
  • PAH
    patients with pulmonary arterial hypertension without left ventricular dysfunction
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. 2012 Dec 4. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Sebastian Greiner, M.D. +49622156 ext 36775 sebastian.greiner@med.uni-heidelberg.de
Contact: Derliz Mereles, M.D. +49622156 ext 8852 derliz.mereles@med.uni-heidelberg.de
Germany
 
NCT01230294
S275-2010
Yes
Derliz Mereles, University of Heidelberg
University of Heidelberg
Not Provided
Principal Investigator: Sebastian Greiner, M.D. University of Heidelberg
Principal Investigator: Derliz Mereles, M.D. University of Heidelberg
University of Heidelberg
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP