Assessment of Endothelial Function, Apolipoproteins and Adiponectin (Endo-PAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01300390
Recruitment Status : Completed
First Posted : February 21, 2011
Last Update Posted : May 17, 2016
Information provided by (Responsible Party):
Kymberly D. Watt, 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.

Condition or disease

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 Type : Observational
Actual Enrollment : 150 participants
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
Study Start Date : June 2011
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

End-stage liver disease pre-transplant
Patients with end-stage liver disease (non-fulminant) awaiting liver transplant

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples Without DNA
Serum samples will be retained for future liver transplant research.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cirrhotic end-stage liver disease awaiting transplant

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01300390

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Kymberly Watt, MD Mayo Clinic


Responsible Party: Kymberly D. Watt, M.D., Mayo Clinic Identifier: NCT01300390     History of Changes
Other Study ID Numbers: 10-008776
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Kymberly D. Watt, Mayo Clinic:
liver transplant
end-stage liver disease

Additional relevant MeSH terms:
Pathologic Processes