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CompletedNCT05006443Updated May 13, 2025

Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

An interventional study of Cardiac Magnetic Resonance in Tricuspid Regurgitation, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Tricuspid Regurgitation
03

In context

Tricuspid Valve Insufficiency

225 studies on the registry are indexed under Tricuspid Valve Insufficiency; 108 are open to participants now.

This study's enrollment of 75 is above the median of 60 across 124 interventional studies indexed under Tricuspid Valve Insufficiency.

Browse Tricuspid Valve Insufficiency studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,264 studies on the registry; 670 are open to participants now.

Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Moderate or more tricuspid regurgitation

Exclusion criteria

Exclusion Criteria:

  1. Prior tricuspid valve prosthesis
  2. Pacemaker/defibrillator that would impede MRI imaging
  3. Planned tricuspid valve surgery
  4. Primary liver pathology
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • 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

Interventions

  • Diagnostic testCardiac Magnetic Resonance

    a non-invasive assessment to determine severity of tricuspid regurgitation

    Also known as: Cardiac MRI

06

What researchers measure

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)

    Time frame: 1 year

Secondary outcomes

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

    Correlation between severity of TR by CMR vs. echocardiography with 1-year composite endpoint of death, heart failure hospitalization, or tricuspid valve surgery.

    Time frame: 1 year

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2022 to primary completion in Dec 2023, 22 months.

Of 83 interventional studies with no phase under Tricuspid Valve Insufficiency, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 58. This study's 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2021
First posted
Aug 16, 2021
StartActual
Jan 14, 2022
Primary completionActual
Dec 12, 2023
CompletionActual
Apr 30, 2025
Last update
May 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05006443
Lead sponsor
Mayo Clinic
Responsible party
Mohamad Adnan Alkhouli (Professor of Medicine, Mayo Clinic) — Principal investigator
First posted
Aug 16, 2021
Start date
Jan 14, 2022
Primary completion
Dec 12, 2023
Completion
Apr 30, 2025
Last update
May 13, 2025

Study contacts

Mohamad Alkhouli, MD
principal investigator · Mayo Clinic

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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