Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation (TRAP)

April 11, 2023 updated by: Rennes University Hospital
The aim of this study is to improve the definition of the two main types of secondary tricuspid regurgitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • Chu Amiens-Picardie - Site Sud
      • Créteil, France, 94000
        • AP-HP - Hôpital Henri Mondor
      • Dijon, France, 21034
        • CHU de Dijon - Hôpital François Mitterand
      • Grenoble, France, 38043
        • Chu Grenoble - Michallon
      • Lomme, France, 59462
        • GHICL - Hôpital Saint Philibert
      • Marseille, France, 13285
        • Hôpital Saint Joseph
      • Marseille, France, 13015
        • CHU Marseille - Hopital Nord
      • Montauban, France, 82000
        • Clinique Du Pont De Chaume
      • Montpellier, France, 34960
        • Clinique du Millénaire
      • Nancy, France, 54511
        • CHU de Nancy - Hopital de Brabois
      • Nantes, France, 44093
        • CHU de Nantes - Hôtel Dieu
      • Paris, France, 75571
        • Ap-Hp - Hopital Saint-Antoine
      • Pessac, France, 33600
        • Chu de Bordeaux - Groupe Hospitalier Sud
      • Rennes, France, 35000
        • CHU de Rennes
      • Toulouse, France, 31059
        • CHU de Toulouse - Hopital Rangueil
      • Tours, France, 37044
        • CHU DE TOURS - Hopital Trousseau
      • Tours, France, 37042
        • Clinique NCT+

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2017

Primary Completion (Actual)

October 25, 2021

Study Completion (Actual)

March 23, 2023

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC16_8919_TRAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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