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

Tricuspid Valve Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444222
• Other study ID #: s53471
• Status: Completed
• Start date: October 18, 2011
• Est. completion date: January 31, 2014

Study information

• Verified date: January 2011
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, …).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2014
• Est. primary completion date: May 24, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium,