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

NCT ID: NCT01444222

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-18

Study Completion Date

2014-01-31

Brief Summary

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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, …).

Detailed Description

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Conditions

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Tricuspid Valve Insufficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pulmonary Hypertension

No interventions assigned to this group

pulmonic valve stenosis

No interventions assigned to this group

pulmonic valve homograft

No interventions assigned to this group

pulmonic valve insufficiency

No interventions assigned to this group

atrial septum defect

No interventions assigned to this group

Ebstein's anomaly

No interventions assigned to this group

transvalvular right ventricular lead

No interventions assigned to this group

control

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Werner Budts, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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UZLeuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 24780907 (View on PubMed)

Other Identifiers

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s53471

Identifier Type: -

Identifier Source: org_study_id

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