MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair

Not Applicable

Withdrawn

• Conditions: Tricuspid Valve Insufficiency
• Interventions: Device: MRI

• Registration Number: NCT03166488
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-25
• Status Verified: 2018-06
• Primary Completion: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-13
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tricuspid Valvular Repair Patients	MRI	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.

Primary Outcome Measures

Name	Time	Method
Change in liver stiffness between preoperative and postoperative MR elastography (MRE)	baseline, approximately 6 months postoperatively	Increased liver stiffness often means there is chronic liver disease and fibrosis.
Change in tricuspid valve regurgitation measured by echocardiography	baseline, approximately 6 months postoperatively	Increased liver stiffness may be due to a poorly functioning tricuspid valve.

Secondary Outcome Measures

Name	Time	Method
Change in Subject Functional Capacity	baseline, approximately 6 months postoperatively	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.