Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation

Last updated: May 6, 2021
Sponsor: Heart Center Leipzig - University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04141683
RESERVE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 108
Study Start date:
June 10, 2019
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Heart Center Leipzig at Leipzig University

    Leipzig, 04289
    Germany

    Active - Recruiting

+−

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.