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RecruitingNCT03546231EPITUpdated Jun 15, 2026

Characteristics and Prognosis of Moderate or Severe Tricuspid Regurgitation

An observational study in Tricuspid Valve Disease, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Months and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Mar 2018; still recruiting 8 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Months and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Tricuspid Valve Disease

Keywords

  • Tricuspid regurgitation
  • tricuspid valve
  • surgery
  • outcome
  • prognosis
  • mortality
  • right ventricle
  • asymptomatic
03

In context

Tricuspid Valve Insufficiency

219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 96 observational studies indexed under Tricuspid Valve Insufficiency.

Browse Tricuspid Valve Insufficiency studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with moderate or severe tricuspid regurgitation.

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Overall survival

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

    Time frame: 5 Years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03546231
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jun 6, 2018
Start date
Mar 15, 2018
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Jun 15, 2026

Study contacts

Christophe TRIBOUILLOY, Pr
Contact
Tribouilloy.Christophe@chu-amiens.fr
03 22 45 58 85
Christophe TRIBOUILLOY, Pr
principal investigator · CHU AMIENS-PICARDIE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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