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NCT Number: NCT03546231

Characteristics and Prognosis of Moderate or Severe Tricuspid Regurgitation

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

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Key information

Age range

18 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

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

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 5 Years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe TRIBOUILLOY, Pr

CONTACT

[email protected]

03 22 45 58 85

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study 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

Acronym: EPIT

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2018
Registry last updated
Jun 15, 2026

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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