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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kymberly D. Watt, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01300390
First received: February 17, 2011
Last updated: May 13, 2016
Last verified: May 2016
  Purpose
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 Phase
Cirrhosis
Phase 0

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.

Enrollment: 150
Study Start Date: June 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
End-stage liver disease pre-transplant
Patients with end-stage liver disease (non-fulminant) awaiting liver transplant

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

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cirrhotic end-stage liver disease awaiting transplant
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300390

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

Publications:

Responsible Party: Kymberly D. Watt, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01300390     History of Changes
Other Study ID Numbers: 10-008776 
Study First Received: February 17, 2011
Last Updated: May 13, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
liver transplant
end-stage liver disease
cirrhosis

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 27, 2016