Assessment of Endothelial Function, Apolipoproteins and Adiponectin

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cirrhosis Digestive System Diseases End Stage Liver Disease Fibrosis Hepatic Insufficiency Liver Diseases Liver Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Dialysis shunt
non-cirrhotic liver disease
fulminant hepatic failure

Treatment and study plan

Primary outcomes

Endothelial dysfunction in cirrhotic liver transplant candidates up to one year after transplant.

Time frame: 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 outcomes

Metabolic abnormalities and cardiovascular disease by endothelial dysfunction and blood testing up to one year pre-transplant

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Assessment of Endothelial Function, Apolipoproteins, and Adiponectin Levels as Markers of Cardiovascular Before and After Liver Transplantation

Acronym: Endo-PAT

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Feb 21, 2011
Registry last updated: May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed