RESERVE: Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation

Sponsor

Heart Center Leipzig - University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04141683

Collaborator

(none)

108

Enrollment

Location

41.7

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Functional Tricuspid Regurgitation	Diagnostic Test: Stress Echocardiography Diagnostic Test: Pressure volume loop analysis Procedure: 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 Design

Study Type:

Observational

Anticipated Enrollment :

108 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 10, 2019

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Death or heart failure hospitalization [6-12 month]
Death or heart failure hospitalization according to right ventricular contractile reserve.

Secondary Outcome Measures

Death [6-12 month]
Death according to right ventricular contractile reserve.
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.
Intrinsic RV contractility [Baseline]
Correlation of RV contractile reserve with the slope of invasively derived right ventricular end systolic elastance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.