Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation

Study Overview
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Brief Summary
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Aim of the study is to investigate the prognostic value of right ventricular contractile reserve in patients with functional tricuspid regurgitation undergoing tricuspid valve repair or replacement.

Detailed Description
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Chronic volume overload in patients with severe tricuspid regurgitation (TR) leads to right ventricular (RV) dilatation, fibrosis and eventually failure. RV dysfunction is an important determinant of mortality in patients undergoing tricuspid valve surgery. Aim of the current study is to investigate the prognostic utility of right ventricular contractile reserve in patients with severe TR undergoing surgical or interventional tricuspid valve repair or tricuspid valve replacement. RV contractile reserve will be assessed using semi-supine bicycle stress echocardiography. Echocardiographic parameters are prone to altered loading conditions, such as volume overload. Load independent RV contractility can only be measured using invasive pressure-volume-loop (PVL) analysis. Therefore RV PVL analysis will be done using conductance catheter in a subset of patients who undergo right heart catheterization for clinical evaluation of pulmonary hypertension. Aim of this sub study is the validation of non-invasively derived RV contractile reserve with load independent markers of intrinsic RV contractility.

Official Title
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Prognostic Implication of Right Ventricular Contractile Reserve in Patients With Functional Tricuspid Regurgitation

Conditions
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Functional Tricuspid Regurgitation

Intervention / Treatment
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* Diagnostic Test: Stress Echocardiography
* Diagnostic Test: Pressure volume loop analysis
* Procedure: Tricuspid valve repair or replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe functional tricuspid regurgitation. Planned surgical or interventional tricuspid valve repair or replacement. Able to cycle on a semisupine tilting exercise table. Informed consent. Exclusion Criteria: Coronary artery disease with significant ischemia. Unstable Angina. Myocardial infarction <4 month prior to inclusion. Concomitant valvular heart disease (aortic, mitral or pulmonary valve) > mild-moderate. Constrictive pericarditis. Malignant disease with a life expectancy < 12 months. Pregnancy. Insufficient image quality on echocardiography.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Stress Echocardiography|Dynamic stress echocardiography using a cycle ergometer on a semi supine exercise table.|
|Diagnostic Test: Pressure volume loop analysis|Pressure volume loop analysis unsing conductance catheter measurements during right heart catheterization.|
|Procedure: Tricuspid valve repair or replacement|Tricuspid valve repair or replacement using a surgical or interventionale approach according to local heart team recommendation and patients' preference.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or heart failure hospitalization | Death or heart failure hospitalization according to right ventricular contractile reserve. | 6-12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Death according to right ventricular contractile reserve. | 6-12 month | 
| Cardiovascular Death | Cardiovascular Death according to right ventricular contractile reserve. | 6-12 month | 
| Heart Failure Hospitalization | Heart Failure Hospitalization according to right ventricular contractile reserve. | 6-12 month | 
| Intrinsic RV contractility | Correlation of RV contractile reserve with the slope of invasively derived right ventricular end systolic elastance. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tricuspid regurgitation, heart failure, right heart, stress echocardiography, tricuspid repair, tricuspid replacement