Cardiac MRI for Tricuspid Regurgitation

Overseen By Mohamad Alkhouli

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Tricuspid prosthesis, Pacemaker, Liver pathology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

75 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Mohamad Alkhouli, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with moderate or severe tricuspid regurgitation, which is when the heart's tricuspid valve doesn't close properly. Participants must not have a pacemaker/defibrillator that interferes with MRI, any prior tricuspid valve replacements, planned surgery on the tricuspid valve, or primary liver disease.

Inclusion Criteria

You have moderate or severe tricuspid regurgitation.

Exclusion Criteria

You have had a replacement of your tricuspid valve in the past.

You have a pacemaker or defibrillator that would make it difficult to take MRI pictures.

You are scheduled to have surgery on your tricuspid valve.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo cardiac magnetic resonance imaging (CMR) and magnetic resonance elastography (MRE) with contrast to assess tricuspid regurgitation severity and associated abnormalities.

1-2 weeks

1 visit (in-person)

Follow-up

1-year follow-up conducted via phone to inquire about patient's vital status, symptoms, and hospitalizations.

1 year

1 visit (virtual)

Treatment Details

Interventions

• Cardiac Magnetic Resonance

Trial Overview The study aims to evaluate how well cardiac magnetic resonance imaging (MRI) can determine the severity of tricuspid regurgitation in patients' hearts.

Participant Groups

Group I: Moderate or severe tricuspid regurgitation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+