MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-12-31

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.

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Detailed Description

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Conditions

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Tricuspid Valve Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Tricuspid Valvular Repair Patients

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.

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE).

Interventions

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MRI

Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE).

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No