NCT06169345

Brief Summary

To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

September 26, 2023

Last Update Submit

December 12, 2023

Conditions

Tricuspid RegurgitationHeart FailureEchocardiography

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    Time from diagnosis to all-cause death

    through study completion, an average of 2 years

Secondary Outcomes (1)

  • Cardiovascular (CV) mortality

    through study completion, an average of 2 years

Interventions

Echocardiographic evaluationOTHER

Echocardiographic follow-up

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an echocardiographic diagnosis of moderate tricuspid regurgitation at our center between 2010 and 2019

You may qualify if:

  • Patients with an echocardiographic diagnosis of moderate TR
  • Patients with echocardiographic and clinical follow-up information available at least 6-months after moderateTR diagnosis.

You may not qualify if:

  • Absence of an appropriate clinical and echocardiographic follow-up
  • A history of previous TV intervention (either surgical or percutaneous)
  • The presence of concomitant TV stenosis
  • Congenital heart disease
  • Left ventricular assist devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs San Raffaele

Milan, 20900, Italy

Location

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyHeart Failure

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiovascular Imaging Department

Study Record Dates

First Submitted

September 26, 2023

First Posted

December 13, 2023

Study Start

May 1, 2021

Primary Completion

August 1, 2022

Study Completion

February 1, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)