Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
|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: NCT01444222|
Recruitment Status : Unknown
Verified September 2011 by Pieter De Meester, Universitaire Ziekenhuizen Leuven.
Recruitment status was: Not yet recruiting
First Posted : September 30, 2011
Last Update Posted : October 3, 2011
Right-sided heart disease has an important impact on the prognosis of patients with valvular heart disease. Up to now, Tricuspid Valve Regurgitation (TR) and right heart hemodynamics have not been extensively investigated. However, it is plausible that a significant degree of TR and the associated volume-overload of the right ventricle cause significant right ventricular wall stress. Although minor TR generally is well tolerated, major TR can lead to clinical symptoms, right ventricular dilatation and ultimately right ventricular heart failure. Up to now, the investigators do not dispose of any tools to diagnose and anticipate this unfavourable evolution. Nevertheless it is likely that right ventricular failure is preceded with a subclinical dysfunction of the right ventricle and a possibly reversible change in contractility of the myocardium.
Recently, new techniques to evaluate the systolic function, the contractility and the hemodynamics of the heart have become available.
First, this study will help us assessing the feasibility and accuracy of several imaging modalities in right-sided heart pathology with focus on TR and right heart myocardial performance.
Second, this study will contribute to a better understanding of the hemodynamic effect of volume-overload and/or pressure-overload of the right ventricle. It will clarify the behaviour of TR, the evolution of right ventricular myocardial contractility and dysfunction during exercise and its impact on exercise capacity. By doing this, discrimination between well tolerated and ill-tolerated TR will be possible, thus identifying patients who might be eligible for treatment (medical, corrective, …).
|Condition or disease|
|Tricuspid Valve Insufficiency|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Observational Model:||Case Control|
|Official Title:||Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart|
|Study Start Date :||October 2011|
|Estimated Study Completion Date :||August 2012|
|pulmonic valve stenosis|
|pulmonic valve homograft|
|pulmonic valve insufficiency|
|atrial septum defect|
|transvalvular right ventricular lead|
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): NCT01444222
|Contact: Pieter De Meester, MD||016342371 ext email@example.com|
|UZLeuven||Not yet recruiting|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Contact: Pieter De Meester, MD 016342371 ext 0032 firstname.lastname@example.org|
|Principal Investigator:||Werner Budts, MD, PhD||Universitaire Ziekenhuizen Leuven|