MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair

Tricuspid Valve Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03166488
• Other study ID #: 16-009548
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: June 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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