Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
Information source: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tricuspid Valve Insufficiency
Phase: N/A
Status: Not yet recruiting
Sponsored by: Pieter De Meester Official(s) and/or principal investigator(s):
Werner Budts, MD, PhD, Principal Investigator, Affiliation: Universitaire Ziekenhuizen Leuven
Overall contact:
Pieter De Meester, MD, Phone: 016342371, Ext: 0032, Email: pieter.demeester@uzleuven.be
Summary
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, …).
Clinical Details
Official title: Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
Study design: Observational Model: Case Control, Time Perspective: Cross-Sectional
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Pulmonary Arterial Hypertension
- Pulmonic Valve Stenosis
- Pulmonic valve homograft
- Pulmonic valve insufficiency
- Atrium Septum Defect
- Ebstein's Anomaly
- Transvalvular RV pacemaker/ shock lead
- Control
Exclusion Criteria:
- age < 16 years
- not fit for bicycle testing
Locations and Contacts
Pieter De Meester, MD, Phone: 016342371, Ext: 0032, Email: pieter.demeester@uzleuven.be
UZLeuven, Leuven, Vlaams-Brabant 3000, Belgium; Not yet recruiting
Pieter De Meester, MD, Phone: 016342371, Ext: 0032, Email: pieter.demeester@uzleuven.be
Additional Information
Starting date: October 2011
Last updated: September 30, 2011
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