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MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair

Primary Purpose

Tricuspid Valve Insufficiency

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tricuspid Valve Insufficiency

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Tricuspid Valvular Repair Patients

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Change in liver stiffness between preoperative and postoperative MR elastography (MRE)
    Increased liver stiffness often means there is chronic liver disease and fibrosis.
    Change in tricuspid valve regurgitation measured by echocardiography
    Increased liver stiffness may be due to a poorly functioning tricuspid valve.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    May 19, 2017
    Last Updated
    June 11, 2018
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03166488
    Brief Title
    MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair
    Official Title
    Evaluation of Liver Stiffness After Tricuspid Valvular Repair Using Magnetic Resonance Elastography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    slow accrual
    Study Start Date
    May 1, 2017 (Actual)
    Primary Completion Date
    June 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tricuspid Valve Insufficiency

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tricuspid Valvular Repair Patients
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    MRI
    Intervention Description
    Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE).
    Primary Outcome Measure Information:
    Title
    Change in liver stiffness between preoperative and postoperative MR elastography (MRE)
    Description
    Increased liver stiffness often means there is chronic liver disease and fibrosis.
    Time Frame
    baseline, approximately 6 months postoperatively
    Title
    Change in tricuspid valve regurgitation measured by echocardiography
    Description
    Increased liver stiffness may be due to a poorly functioning tricuspid valve.
    Time Frame
    baseline, approximately 6 months postoperatively
    Secondary Outcome Measure Information:
    Title
    Change in Subject Functional Capacity
    Description
    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.
    Time Frame
    baseline, approximately 6 months postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael L Wells
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair

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