MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair

Study Overview
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Brief Summary
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The purpose of this study is to look at liver stiffness with a MRI sequence called Magnetic Resonance Elastography (MRE). The study will let the investigators know whether the subject's liver is normal or has increased stiffness. Increased liver stiffness often means there is chronic liver disease and fibrosis. Increased right heart pressure and congestive heart failure are considered risk factors for development of liver fibrosis. Liver fibrosis, if progressive, may lead to cirrhosis and its related complications. The increased liver stiffness may be due to a poorly functioning tricuspid valve. With this research, the investigators will be able to determine if the elevated stiffness of the liver returns to normal after the surgeon performs a repair or replacement of the tricuspid valve.

Official Title
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Evaluation of Liver Stiffness After Tricuspid Valvular Repair Using Magnetic Resonance Elastography

Conditions
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Tricuspid Valve Insufficiency

Intervention / Treatment
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* Device: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Primary tricuspid valvular regurgitation (tricuspid valve disease not related to a left-sided cardiac abnormality) diagnosed by echocardiography Evidence of passive hepatic congestion. Patients with severe tricuspid regurgitation diagnosed at echocardiography will constitute evidence of passive hepatic congestion. Patient scheduled for surgical tricuspid valvular repair or replacement. Exclusion criteria: Contraindication for MRI (implantable devices such as cardiac pacemaker, anxiety, inability to lay supine, etc). Additional conditions which may elevate their liver stiffness: hepatic fibrosis or cirrhosis, hepatic parenchymal disease (primary biliary cirrhosis, primary sclerosing cholangitis, etc), acute or chronic hepatitis (viral, substance or medication induced), disorders of hepatic vasculature, biliary obstruction or disease, primary or metastatic hepatic malignancy. Cannot agree to return for a follow up visit to complete the postsurgical imaging.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tricuspid Valvular Repair Patients<br>Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE) within 1 month preoperatively and as close to 6 months postoperatively as reasonably achievable. | Device: MRI<br>* Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver stiffness between preoperative and postoperative MR elastography (MRE) | Increased liver stiffness often means there is chronic liver disease and fibrosis. | baseline, approximately 6 months postoperatively | 
| Change in tricuspid valve regurgitation measured by echocardiography | Increased liver stiffness may be due to a poorly functioning tricuspid valve. | baseline, approximately 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subject Functional Capacity | Subject Functional Capacity will be measured by the Self Assessment New York Heart Association (NYHA) Classification Scale. This questionnaire consists of 4 questions regarding the subject's ability to carry on physical activities. NYHA Class I = no symptoms in regular activity; NYHA Class II = Mild symptoms and slight limitation; NYHA Class III = noticeable limitations even during minimal activity; NYHA Class IV = severe limitations even while at rest. | baseline, approximately 6 months postoperatively |