- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01444222
Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
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, …).
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- UZLeuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Pulmonary Arterial Hypertension
- Pulmonic Valve Stenosis
- Pulmonic valve insufficiency
- Atrium Septum Defect
- Ebstein's Anomaly
- Transvalvular RV pacemaker/ shock lead
- Control
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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control
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Pulmonary Hypertension
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pulmonic valve stenosis
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pulmonic valve homograft
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pulmonic valve insufficiency
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atrial septum defect
|
Ebstein's anomaly
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transvalvular right ventricular lead
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Collaborators and Investigators
Investigators
- Principal Investigator: Werner Budts, MD, PhD, Universitaire Ziekenhuizen KU Leuven
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- s53471
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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