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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 because the information has not been verified recently.
Verified September 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Pieter De Meester, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01444222
First received: September 27, 2011
Last updated: September 30, 2011
Last verified: September 2011
  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 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Universitaire Ziekenhuizen Leuven

Additional 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
Study First Received: September 27, 2011
Last Updated: September 30, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Myocardial contractility
Quantification of regurgitant flow
exercise capacity

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

ClinicalTrials.gov processed this record on November 24, 2014