MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair

NCT03166488 | Withdrawn FDA Device

• 1 other identifier: 16-009548
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tricuspid Valve Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Subject Functional Capacity

  baseline, approximately 6 months postoperatively

Study Arms (1)

Tricuspid Valvular Repair Patients

EXPERIMENTAL

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

Interventions

MRI DEVICE

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

Tricuspid Valvular Repair Patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael L Wells

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 25, 2017
• Study Start: May 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06