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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses cardiac MRI (a detailed heart scan) to assess the severity of tricuspid regurgitation, a condition where the heart's tricuspid valve doesn't close tightly, potentially causing problems. Patients with moderate or severe tricuspid regurgitation will undergo an MRI to evaluate their condition. Those with more than moderate tricuspid regurgitation and no metal devices like pacemakers are suitable candidates. This process helps doctors better understand the condition and plan future care. As an unphased trial, it offers patients the chance to contribute to medical knowledge and improve future treatments for tricuspid regurgitation.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that cardiac MRI is safe for assessing tricuspid regurgitation?

Research has shown that cardiac magnetic resonance (CMR) safely and effectively examines heart conditions, including tricuspid valve issues. CMR is non-invasive, meaning it doesn't require surgery or inserting instruments into the body. Studies have found that CMR is generally safe and well-received by patients in medical settings.

In one study, CMR succeeded in all procedures, with no procedure-related deaths and 98% of patients experiencing no major side effects within 30 days. Another study demonstrated that CMR does not harm the left side of the heart, reassuring patients concerned about other heart functions.

Overall, CMR appears to be a reliable and safe imaging option for individuals with heart valve issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cardiac Magnetic Resonance (CMR) for tricuspid regurgitation because it offers a non-invasive and highly detailed way to assess the severity of the condition. Unlike traditional echocardiography, CMR provides clearer images of the heart and surrounding structures, which can reveal extra-valvular cardiac and liver abnormalities. This method could lead to more accurate diagnoses and better-tailored treatments for patients, potentially improving outcomes.

What evidence suggests that cardiac MRI is effective for assessing tricuspid regurgitation?

Research has shown that cardiac magnetic resonance (CMR) is a valuable tool for evaluating tricuspid regurgitation (TR), a condition where the heart's tricuspid valve doesn't close properly. In this trial, patients with moderate or severe TR will undergo CMR to assess TR severity and associated cardiac and liver abnormalities. CMR provides more accurate assessments of TR severity than traditional ultrasound tests. Studies have found that certain CMR measurements correlate with outcomes like a higher risk of death in severe TR cases. This imaging method offers a clearer view of heart function and can help predict the condition's progression. Therefore, CMR is a promising way to assess patients with TR. ^{1 6 7 8 9}

Who Is on the Research Team?

Mohamad Alkhouli, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11312898/

Assessment of Tricuspid Regurgitation by Cardiac Magnetic ... Several CMR-derived parameters have been associated with outcome, highlighting the importance of multi-modality imaging in patients with TR.

2. jacc.org jacc.org/doi/10.1016/j.jacc.2020.07.036

Natural History of Functional Tricuspid Regurgitation ... This is the first study to use CMR to assess independent prognostic implications of functional TR. Both TRF and TRVol were associated with increased mortality.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X25001760

Prospective Quantification of Tricuspid Regurgitation With ... There was no agreement between TTE and CMR-derived TR fraction (kappa = 0.04, 95% CI: 0.13-0.46), with only 3 of 31 patients (13%) with ≥ severe TR on TTE ...

4. academic.oup.com academic.oup.com/eurheartj/article/41/Supplement_2/ehaa946.1911/6005835

Outcomes in severe tricuspid regurgitation by CMR Patients with massive and torrential TR showed higher RV end-diastolic volume and lower RVEF. A TR regurgitant fraction (TRF) >50% held the best ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCIMAGING.120.012211

Prognostic Value of Complementary Echocardiography ... Isolated tricuspid regurgitation (TR) remains a management dilemma with poor outcomes. Echocardiography and cardiac magnetic resonance ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05006443

Staging Classification of Severe Tricuspid Regurgitation ... 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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1875213624000378

Feasibility, safety and diagnostic yield of interventional ... CMR-RHC seems to be a feasible and safe procedure that can be used in routine daily practice in consecutive adults with an impactful clinical yield.

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.032999

Tricuspid Regurgitation: A Review of Current Interventional ... Safety data were also promising: 100% procedural success rate, no procedural deaths, and 98% free from major adverse events at 30‐day follow‐up.

9. jacc.org jacc.org/doi/10.1016/j.jcmg.2022.12.014

Right Heart Remodeling Assessed by Cardiac Magnetic ... CMR confirmed that the left ventricle (LV) is not negatively affected by TTVA. LV geometry and function did not show any significant changes.