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Clinical Trials/NCT03546231
NCT03546231
Recruiting
Not Applicable

Clinical and Echocardiographic Characteristics and Prognosis of trIcuspid regurgiTation (EPIT): Prospective and Retrospective Follow-up of a Cohort of Patients With Moderate or Severe Tricuspid Regurgitation

Centre Hospitalier Universitaire, Amiens1 site in 1 country400 target enrollmentMarch 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tricuspid Valve Disease
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
400
Locations
1
Primary Endpoint
Overall survival
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The tricuspid valve : its evaluation is relatively difficult in echocardiography and the management of tricuspid valve diseases remains poorly codified.

Detailed Description

The tricuspid valve is often called the "forgotten valve" because its evaluation is relatively difficult in echocardiography and the management of tricuspid valve diseases remains poorly codified. In developed countries, TR is mainly functional, related to a remodeling of the right cavities in response to an increase in the load conditions. This remodeling induces a dilation of the tricuspid ring and / or a "tenting" of the tricuspid leaflets. Once TR is present, a vicious circle settles because TR increases right ventricle dilation. Transthoracic echocardiography is the key examination allowing noninvasive, quantification and assessment of hemodynamic repercussions of TR. TR remains asymptomatic for a long time, often diagnosed with a significant delay at the stage of advanced right heart failure. At this stage, the surgical risk is important, at least more important than for left heart valve diseases and it is therefore essential to define the right time for proposing valvular surgery to patients. Indeed, TR is an independent factor of mortality and only surgical treatment improves the prognosis. Current guidelines remain vague given the low number of prognostic studies and of their contradictory results often influenced by the significant comorbidities of patients, the presence of pulmonary hypertension or left heart valve disease. Only a minority of patients (\<1%) is referred to surgery because operative mortality is often judged unacceptable in elderly patients or in cases of advanced right ventricular dysfunction. The constitution of a prospective and retrospective cohort will improve the state of knowledge on etiologies, natural history, prognosis and management of patients with moderate or severe TR.

Registry
clinicaltrials.gov
Start Date
March 2, 2018
End Date
July 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \>18 ans
  • inclusion criteria: moderate or severe tricuspid regurgitation
  • exclusion criteria: Refusal to participate/ prior surgery of the tricuspid valve

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Overall survival

Time Frame: 5 Years

It corresponds to the delay between the diagnostic and the date of death.

Study Sites (1)

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