NCT01444222

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, …).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
18 days until next milestone

Study Start

First participant enrolled

October 18, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2014

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2011

Enrollment Period

1.6 years

First QC Date

September 27, 2011

Last Update Submit

January 23, 2023

Conditions

Tricuspid Valve Insufficiency

Keywords

Myocardial contractilityQuantification of regurgitant flowexercise capacity

Study Arms (8)

Pulmonary Hypertension

pulmonic valve stenosis

pulmonic valve homograft

pulmonic valve insufficiency

atrial septum defect

Ebstein's anomaly

transvalvular right ventricular lead

control

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Pulmonary Arterial Hypertension
  • Pulmonic Valve Stenosis
  • Pulmonic valve homograft
  • Pulmonic valve insufficiency
  • Atrium Septum Defect
  • Ebstein's Anomaly
  • Transvalvular RV pacemaker/ shock lead
  • Control

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 24780907DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Werner Budts, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2011

First Posted

September 30, 2011

Study Start

October 18, 2011

Primary Completion

May 24, 2013

Study Completion

January 31, 2014

Last Updated

January 26, 2023

Record last verified: 2011-01

Locations

BE(1)