NCT05006443

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

July 31, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

July 31, 2021

Last Update Submit

May 9, 2025

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging

    Incidence of severity of TR by CMR as compared with current gold standard (TTE)

    1 year

Secondary Outcomes (1)

  • Correlation between severity of Tricuspid regurgitation by cardiac magnetic resonance imaging vs. elastography

    1 year

Study Arms (1)

Moderate or severe tricuspid regurgitation

OTHER

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

Interventions

Cardiac Magnetic ResonanceDIAGNOSTIC_TEST

a non-invasive assessment to determine severity of tricuspid regurgitation

Also known as: Cardiac MRI
Moderate or severe tricuspid regurgitation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate or more tricuspid regurgitation

You may not qualify if:

  • Prior tricuspid valve prosthesis
  • Pacemaker/defibrillator that would impede MRI imaging
  • Planned tricuspid valve surgery
  • Primary liver pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Mohamad Alkhouli, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 31, 2021

First Posted

August 16, 2021

Study Start

January 14, 2022

Primary Completion

December 12, 2023

Study Completion

April 30, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations

US(1)