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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01444222
Enrollment
20
Registered
2011-09-30
Start date
2011-10-18
Completion date
2014-01-31
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Valve Insufficiency

Keywords

Myocardial contractility, Quantification of regurgitant flow, exercise capacity

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, …).

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026