NCT04141683

Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 108 (estimated)
• Sponsor: Heart Center Leipzig - University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Tricuspid Regurgitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-10
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2019-10-28
• Last updated: 2021-05-10

Locations

1 site across 1 country: Germany