Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation

Completed

• Conditions: Tricuspid Regurgitation; Remodeling, Cardiac

• Registration Number: NCT03159923
• Lead Sponsor: Rennes University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-19
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Status Verified: 2018-09
• Primary Completion: 2021-10-25
• Study Completion: 2023-03-23
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (17)

Chu Amiens-Picardie - Site Sud; 🇫🇷 Amiens, France

Ap-Hp - Hopital Henri Mondor; 🇫🇷 Créteil, France

CHU de DIJON - HOPITAL FRANCOIS MITTERAND; 🇫🇷 Dijon, France

Chu Grenoble - Michallon; 🇫🇷 Grenoble, France

Ghicl - Hopital Saint Philibert; 🇫🇷 Lomme, France

Chu Marseille - Hopital Nord; 🇫🇷 Marseille, France

Hôpital Saint Joseph; 🇫🇷 Marseille, France

Clinique Du Pont de Chaume; 🇫🇷 Montauban, France

CLINIQUE du MILLENAIRE; 🇫🇷 Montpellier, France

Chu de Nancy - Hopital de Brabois; 🇫🇷 Nancy, France

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