Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Diagnostic Test: Cardiac Magnetic Resonance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate or more tricuspid regurgitation Exclusion Criteria: Prior tricuspid valve prosthesis Pacemaker/defibrillator that would impede MRI imaging Planned tricuspid valve surgery Primary liver pathology

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Moderate or severe tricuspid regurgitation<br>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<br>* a non-invasive assessment to determine severity of tricuspid regurgitation<br>* Other names: Cardiac MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year |