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Clinical Trials/NCT01444222
NCT01444222
Completed
N/A

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

Universitaire Ziekenhuizen KU Leuven1 site in 1 country20 target enrollmentOctober 18, 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tricuspid Valve Insufficiency
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
20
Locations
1
Status
Completed
Last Updated
3 years ago

Overview

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, ...).

Registry
clinicaltrials.gov
Start Date
October 18, 2011
End Date
January 31, 2014
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Exclusion Criteria

  • age \< 16 years
  • not fit for bicycle testing

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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