MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Tricuspid Valve Insufficiency
• Intervention / Treatment: Device: MRI

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: MRI; Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Michael L Wells, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ANTICIPATED): June 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (ACTUAL): May 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 16-009548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes