Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation (RESERVE)

Heart Center Leipzig - University Hospital

Status: Unknown

Conditions: Functional Tricuspid Regurgitation

Treatments: Diagnostic Test: Stress Echocardiography; Diagnostic Test: Pressure volume loop analysis; Procedure: Tricuspid valve repair or replacement

Study type: Observational

Funder types: Other

Identifiers

NCT04141683

RESERVE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.