EPIT: Characteristics and Prognosis of Moderate or Severe Tricuspid Regurgitation

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT03546231

Collaborator

(none)

400

Enrollment

Location

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Valve Disease

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 2, 2018

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Outcome Measures

Primary Outcome Measures

Overall survival [5 Years]
It corresponds to the delay between the diagnostic and the date of death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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