Assessment of Endothelial Function, Apolipoproteins and Adiponectin

Completed

• Conditions: Cirrhosis

• Registration Number: NCT01300390
• Lead Sponsor: Mayo Clinic

Brief Summary

The overall hypothesis is that endothelial function, apolipoprotein levels and adiponectin levels are accurate predictors of underlying cardiovascular disease in patients with end-stage liver disease, in whom standard tools for the diagnosis of and screening for cardiovascular disease are of limited utility.

Detailed Description

This study is looking at using a noninvasive test called a reactive hyperemia peripheral artery tonometry (RH-PAT) to check endothelial dysfunction. Endothelial dysfunction is thought to be an indication of future heart disease or metabolic disorders. Adiponectin is a hormone associated with heart disease. Apolipoprotein levels, are established risk factors for coronary artery disease in the general population. Our group would like to see if there is a link between endothelial function, adiponectin, apolipoprotein levels and posttransplant heart disease complications. The study would be taking these results to find new clinical procedures for patients that are at potentially higher risk of heart problems during and after their liver transplant procedure.

Study Timeline

• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-18
• Study First Posted: 2011-02-21
• Study Start: 2011-06
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Greater than or equal to 21 years of age.
• Cirrhotic end-stage liver disease
• Pre-transplant

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Exclusion Criteria

• Dialysis shunt
• non-cirrhotic liver disease
• fulminant hepatic failure

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endothelial dysfunction in cirrhotic liver transplant candidates up to one year after transplant.	one year posttransplant	Endothelial function testing will be performed by reactive hyperemia peripheral artery tonometry in consecutive patients ≥21 years old awaiting liver transplantation and repeated at 3 weeks, 4 months and 1 year post transplantation

Secondary Outcome Measures

Name	Time	Method
Metabolic abnormalities and cardiovascular disease by endothelial dysfunction and blood testing up to one year pre-transplant	1 year posttransplant	Endothelial dysfunction testing, apolipoproteins and adiponectin levels will be performed prior to liver transplantation and repeated at 3 weeks (endothelial dysfunction only), 4 months and 1 year post transplantation. Pre transplant results will be analyzed for association with perioperative cardiovascular events. In addition, post transplant endothelial dysfunction results (and the delta change) along with adiponectin levels will be analyzed for cardiovascular event endpoints by 1 year post transplant.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States