Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation

NCT03159923 | Completed

• 1 other identifier: 35RC16_8919_TRAP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Remodeling, Cardiac; Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

• Composite criteria : cardiovascular death or unscheduled hospitalizations due to cardiovascular event.

  through study completion, an average of 1 year

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography, in patients stabilized.

You may qualify if:

• 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

You may not qualify if:

• 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 …) ;
• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (17)

Chu Amiens-Picardie - Site Sud

Amiens, 80054, France

Location

Ap-Hp - Hopital Henri Mondor

Créteil, 94000, France

Location

CHU de DIJON - HOPITAL FRANCOIS MITTERAND

Dijon, 21034, France

Location

Chu Grenoble - Michallon

Grenoble, 38043, France

Location

Ghicl - Hopital Saint Philibert

Lomme, 59462, France

Location

Chu Marseille - Hopital Nord

Marseille, 13015, France

Location

Hôpital Saint Joseph

Marseille, 13285, France

Location

Clinique Du Pont de Chaume

Montauban, 82000, France

Location

CLINIQUE du MILLENAIRE

Montpellier, 34960, France

Location

Chu de Nancy - Hopital de Brabois

Nancy, 54511, France

Location

CHU de NANTES - HOTEL DIEU

Nantes, 44093, France

Location

Ap-Hp - Hopital Saint-Antoine

Paris, 75571, France

Location

Chu de Bordeaux - Groupe Hospitalier Sud

Pessac, 33600, France

Location

CHU de Rennes

Rennes, 35000, France

Location

CHU de TOULOUSE - HOPITAL RANGUEIL

Toulouse, 31059, France

Location

Clinique NCT+

Tours, 37042, France

Location

CHU de TOURS - HOPITAL TROUSSEAU

Tours, 37044, France

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Erwan DONAL, PhD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 19, 2017
• Study Start: January 19, 2017
• Primary Completion: October 25, 2021
• Study Completion: March 23, 2023
• Last Updated: April 12, 2023

Record last verified: 2018-09

Locations

FR (17)