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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
  Purpose

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


Condition
Right Ventricular Dysfunction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of New Echocardiographic Methods for Measurement of Right Ventricular Function.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • 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)
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230294

Contacts
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

Locations
Germany
University of Heidelberg Recruiting
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Contact: Sebastian Greiner, M.D.     +49622156 ext 36775     sebastian.greiner@med.uni-heidelberg.de    
Principal Investigator: Sebastian Greiner, M.D.            
Principal Investigator: Derliz Mereles, M.D.            
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Sebastian Greiner, M.D. University of Heidelberg
Principal Investigator: Derliz Mereles, M.D. University of Heidelberg
  More Information

Publications:

Responsible Party: Derliz Mereles, Derliz Mereles, M.D., University of Heidelberg
ClinicalTrials.gov Identifier: NCT01230294     History of Changes
Other Study ID Numbers: S275-2010
Study First Received: October 28, 2010
Last Updated: January 29, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:
echocardiography of the right heart
3D 4D echocardiography
strain measurement
chronic heart failure
pulmonary hypertension

Additional relevant MeSH terms:
Ventricular Dysfunction, Right
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013