Prognostic Implication of Right Ventricular Contractile Reserve in Patients With Functional Tricuspid Regurgitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Tricuspid Regurgitation
- Sponsor
- Heart Center Leipzig - University Hospital
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Death or heart failure hospitalization
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Philipp Lurz
Clinical Investigator, Professor, Managing Senior Physician
Heart Center Leipzig - University Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Death or heart failure hospitalization
Time Frame: 6-12 month
Death or heart failure hospitalization according to right ventricular contractile reserve.
Secondary Outcomes
- Intrinsic RV contractility(Baseline)
- Cardiovascular Death(6-12 month)
- Heart Failure Hospitalization(6-12 month)
- Death(6-12 month)