Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart

Completed

• Conditions: Tricuspid Valve Insufficiency

• Registration Number: NCT01444222
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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, ...).

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Study Start: 2011-10-18
• Primary Completion: 2013-05-24
• Study Completion: 2014-01-31
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium