Assessment of Endothelial Function, Apolipoproteins and Adiponectin (Endo-PAT)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Assessment of Endothelial Function, Apolipoproteins, and Adiponectin Levels as Markers of Cardiovascular Before and After Liver Transplantation|
- Endothelial dysfunction in cirrhotic liver transplant candidates up to one year after transplant. [ Time Frame: one year posttransplant ] [ Designated as safety issue: No ]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
- Metabolic abnormalities and cardiovascular disease by endothelial dysfunction and blood testing up to one year pre-transplant [ Time Frame: 1 year posttransplant ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
Serum samples will be retained for future liver transplant research.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
End-stage liver disease pre-transplant
Patients with end-stage liver disease (non-fulminant) awaiting liver transplant
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300390
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Kymberly Watt, MD||Mayo Clinic|