Back to resultsMRE 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Withdrawn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
About this trial
This is an interventional health services research trial for Tricuspid Valve Insufficiency
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.
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
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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