Clinical Trials Directory

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UnknownNCT03546231

Characteristics and Prognosis of Moderate or Severe Tricuspid Regurgitation

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

Status
Unknown
Phase
Study type
Observational
Enrollment
400 (estimated)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
18 Months
Healthy volunteers

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.

Conditions

Timeline

Start date
2018-03-02
Primary completion
2025-07-01
Completion
2025-07-01
First posted
2018-06-06
Last updated
2023-02-10

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03546231. Inclusion in this directory is not an endorsement.