Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation

Tricuspid Regurgitation Clinical Trial

— TRAP  

Official title:

Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159923
• Other study ID #: 35RC16_8919_TRAP
• Status: Completed
• Start date: January 19, 2017
• Est. completion date: March 23, 2023

Study information

• Verified date: September 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 23, 2023
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Remodeling, Cardiac
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
France	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	CHU de NANTES - HOTEL DIEU	Nantes
France	Ap-Hp - Hopital Saint-Antoine	Paris
France	Chu de Bordeaux - Groupe Hospitalier Sud	Pessac
France	CHU de Rennes	Rennes
France	CHU de TOULOUSE - HOPITAL RANGUEIL	Toulouse
France	CHU de TOURS - HOPITAL TROUSSEAU	Tours
France	Clinique NCT+	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite criteria : cardiovascular death or unscheduled hospitalizations due to cardiovascular event.		through study completion, an average of 1 year