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Completed

NCT Number: NCT03159923

Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Amiens-Picardie - Site Sud, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: TRAP

Important dates

Study start
2017
Primary completion
2021
Study completion
2023
First posted
May 19, 2017
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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