The Long-term Course of Moderate Tricuspid Regurgitation (LOCOMOTRI)

December 12, 2023 updated by: Agricola Eustachio, IRCCS San Raffaele

The Long-term Clinical Course of Moderate Tricuspid Regurgitation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20900
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: through study completion, an average of 2 years
Time from diagnosis to all-cause death
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular (CV) mortality
Time Frame: through study completion, an average of 2 years
The occurrence of cardiovascular (CV) mortality (defined as death due to advanced heart failure, coronary ischemic heart disease, sudden cardiac death or due to stroke
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Estimated)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCOMOTRI STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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