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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Pieter De Meester, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444222
First Posted: September 30, 2011
Last Update Posted: October 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pieter De Meester, Universitaire Ziekenhuizen Leuven
  Purpose

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, …).


Condition
Tricuspid Valve Insufficiency

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart

Further study details as provided by Pieter De Meester, Universitaire Ziekenhuizen Leuven:

Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: August 2012
Groups/Cohorts
Pulmonary Hypertension
pulmonic valve stenosis
pulmonic valve homograft
pulmonic valve insufficiency
atrial septum defect
Ebstein's anomaly
transvalvular right ventricular lead
control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444222


Contacts
Contact: Pieter De Meester, MD 016342371 ext 0032 pieter.demeester@uzleuven.be

Locations
Belgium
UZLeuven Not yet recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Pieter De Meester, MD    016342371 ext 0032    pieter.demeester@uzleuven.be   
Sponsors and Collaborators
Pieter De Meester
Investigators
Principal Investigator: Werner Budts, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pieter De Meester, research fellow, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01444222     History of Changes
Other Study ID Numbers: s53471
First Submitted: September 27, 2011
First Posted: September 30, 2011
Last Update Posted: October 3, 2011
Last Verified: September 2011

Keywords provided by Pieter De Meester, Universitaire Ziekenhuizen Leuven:
Myocardial contractility
Quantification of regurgitant flow
exercise capacity

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases