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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kymberly D. Watt, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01300390
First received: February 17, 2011
Last updated: January 21, 2014
Last verified: January 2014
  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.


Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
End-stage liver disease awaiting transplant
Patients with end-stage liver disease (non-fulminant) awaiting liver transplant

  Eligibility

Ages Eligible for Study:   21 Years and older
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
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: January 21, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014