Clinical trial NCT01300390: Assessment of Endothelial Function, Apolipoproteins and Adiponectin
Official title: Assessment of Endothelial Function, Apolipoproteins, and Adiponectin Levels as Markers of Cardiovascular Before and After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Keywords: liver transplant
end-stage liver disease
cirrhosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-02-21
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhotic end-stage liver disease awaiting transplant

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.

Eligibility criteria: 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

Primary outcomes:
measure: Endothelial dysfunction in cirrhotic liver transplant candidates up to one year after transplant.
timeFrame: one year posttransplant
Secondary outcomes:
measure: Metabolic abnormalities and cardiovascular disease by endothelial dysfunction and blood testing up to one year pre-transplant
timeFrame: 1 year posttransplant
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kymberly Watt, MD
role: PRINCIPAL_INVESTIGATOR
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