Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation

• Conditions: Functional Tricuspid Regurgitation

• Registration Number: NCT04141683
• Lead Sponsor: Heart Center Leipzig - University Hospital

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.

Study Timeline

• Study Start: 2019-06-10
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-28
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death or heart failure hospitalization	6-12 month	Death or heart failure hospitalization according to right ventricular contractile reserve.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Heart Center Leipzig at Leipzig University; 🇩🇪 Leipzig, Germany