Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
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Purpose
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 |
|---|
|
Tricuspid Valve Insufficiency |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart |
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | August 2012 |
| Groups/Cohorts |
|---|
| Pulmonary Hypertension |
| pulmonic valve stenosis |
| pulmonic valve homograft |
| pulmonic valve insufficiency |
| atrial septum defect |
| Ebstein's anomaly |
| transvalvular right ventricular lead |
| control |
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
- Pulmonary Arterial Hypertension
- Pulmonic Valve Stenosis
- Pulmonic valve insufficiency
- Atrium Septum Defect
- Ebstein's Anomaly
- Transvalvular RV pacemaker/ shock lead
- Control
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
Contacts and Locations| Contact: Pieter De Meester, MD | 016342371 ext 0032 | pieter.demeester@uzleuven.be |
| Belgium | |
| UZLeuven | Not yet recruiting |
| Leuven, Vlaams-Brabant, Belgium, 3000 | |
| Contact: Pieter De Meester, MD 016342371 ext 0032 pieter.demeester@uzleuven.be | |
| Principal Investigator: | Werner Budts, MD, PhD | Universitaire Ziekenhuizen Leuven |
More Information
No publications provided
| Responsible Party: | Pieter De Meester, research fellow, Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01444222 History of Changes |
| Other Study ID Numbers: | s53471 |
| Study First Received: | September 27, 2011 |
| Last Updated: | September 30, 2011 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by Universitaire Ziekenhuizen Leuven:
|
Myocardial contractility Quantification of regurgitant flow exercise capacity |
Additional relevant MeSH terms:
|
Tricuspid Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013