Clinical trial NCT01444222: Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
Official title: Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Valve Insufficiency
Keywords: Myocardial contractility
Quantification of regurgitant flow
exercise capacity
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Pulmonary Arterial Hypertension
* Pulmonic Valve Stenosis
* Pulmonic valve insufficiency
* Atrium Septum Defect
* Ebstein's Anomaly
* Transvalvular RV pacemaker/ shock lead
* Control

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, ...).


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Werner Budts, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Meester P, Buys R, Van De Bruaene A, Gabriels C, Voigt JU, Vanhees L, Herijgers P, Troost E, Budts W. Functional and haemodynamic assessment of mild-to-moderate pulmonary valve stenosis at rest and during exercise. Heart. 2014 Sep;100(17):1354-9. doi: 10.1136/heartjnl-2014-305627. Epub 2014 Apr 29.