MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-009548
    NCT ID: NCT03166488
    Sponsor Protocol Number: 16-009548

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Wells, M.D.

Contact us for the latest status

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20318357

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