Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

May 9, 2025 updated by: Mohamad Adnan Alkhouli, Mayo Clinic
The purpose of this research is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in the heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

40 patients with moderate or more TR on echocardiography will undergo CMR/MRE with contrast to assess TR severity, and the associated extra-valvular cardiac and liver abnormalities as shown in the flow diagram below. Patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

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

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Moderate or more tricuspid regurgitation

Exclusion Criteria:

  1. Prior tricuspid valve prosthesis
  2. Pacemaker/defibrillator that would impede MRI imaging
  3. Planned tricuspid valve surgery
  4. Primary liver pathology

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Moderate or severe tricuspid regurgitation
40 patients with moderate or more TR on echocardiography will undergo CMR/MRE with contrast to assess TR severity, and the associated extra-valvular cardiac and liver abnormalities. Patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.
Diagnostic test: Cardiac Magnetic Resonance
a non-invasive assessment to determine severity of tricuspid regurgitation
Other Names:
  • Cardiac MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging
Time Frame: 1 year
Incidence of severity of TR by CMR as compared with current gold standard (TTE)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between severity of Tricuspid regurgitation by cardiac magnetic resonance imaging vs. elastography
Time Frame: 1 year
Correlation between severity of TR by CMR vs. echocardiography with 1-year composite endpoint of death, heart failure hospitalization, or tricuspid valve surgery.
1 year

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Mohamad Alkhouli, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

January 14, 2022

Primary Completion (Actual)

December 12, 2023

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

July 31, 2021

First Submitted That Met QC Criteria

August 7, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-003928

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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