NCT01444222

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

Completed Last updated 26 January 2023

What this trial tests

trial in Tricuspid Valve Insufficiency in 20 participants. Completed in 31 January 2014.

Timeline

18 October 2011

Primary endpoint
24 May 2013

31 January 2014

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Status	Completed
Study type	OBSERVATIONAL
Enrollment	20
Start date	18 October 2011
Primary completion	24 May 2013
Estimated completion	31 January 2014
Sites	1 location across Belgium

Conditions studied

• Tricuspid Valve Insufficiency — all drugs for Tricuspid Valve Insufficiency →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

16 and older, any sex, with Tricuspid Valve Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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, …).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Functional and haemodynamic assessment of mild-to-moderate pulmonary valve stenosis at rest and during exercise.
   De Meester P, Buys R, Van De Bruaene A, Gabriels C, et al · · 2014 · cited 13× · PMID 24780907 · DOI 10.1136/heartjnl-2014-305627