Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation

Overview

The aim of this study is to improve the definition of the two main types of secondary tricuspid regurgitation.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 19, 2021

Interventions

  • Other: Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.
    • Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.

Clinical Trial Outcome Measures

Primary Measures

  • Composite criteria : cardiovascular death or unscheduled hospitalizations due to cardiovascular event.
    • Time Frame: through study completion, an average of 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Any patients ≥ 18 years old, with moderate to severe tricuspid regurgitation (≥ 2/4), agreeing to participate ;
  • The patients included can be ambulatory patients or stabilized hospitalised patients (meaning patient clinicaly stable, not decompensated, and whose normovolemia has been checked).
  • Non opposition of the patient

Exclusion Criteria

  • Patient whose accoustic window is judged by the operator as incompatible with a precise evaluation of the tricuspid regurgitation or anatomy of the right cavity ;
  • TR < grade 2 ;
  • TR secondary to primary pulmonary hypertension or congenital cardiopathy ;
  • Primary tricuspid regurgitation (due to rheumatic heart disease, medication – included benfluorex, due to endocarditis, valvular prolapse, carcinoid syndrom or a cardiac stimulation lead …) ;
  • Significant left heart valvulopathy (Mitral regurgitation > grade 2, Aortic insufficiency > grade 2, Mitral stenosis < 2 cm², Aortic stenosis < 1.5 cm²). A valvulopathy sucessfully operated isn't considered as an exclusion criteria;
  • Cardiopathy with significative systolic dysfunction (FE< 40%) ;
  • Patients whose life expectantcy is less than 1 year due to a pathology independent of the TR (neoplasic process for example) ;
  • Patient under judicial protection.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rennes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Erwan DONAL, PhD, Principal Investigator, Rennes University Hospital
  • Overall Contact(s)
    • Kristell COAT, 2 99 28 25 55, kristell.coat@chu-rennes.fr

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