Clinical trial NCT03726229: Cholate Clearance in Fontans
Official title: Development of a Reliable Means for Functional Assessment of Liver Performance After the Fontan Operation: Dual Cholate Clearance Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fontan Procedure
Keywords: liver disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Fontan survivors at least 18 years of age

Brief summary: HepQuant is an assay to measure liver function in other forms of liver disease such as hepatitis C. It measures the ability of the liver to process an naturally occurring substance called cholate and has been shown to predict clinical outcomes in some patient populations.

The Fontan survivor is a patient who has undergone surgery or a series of surgeries that result in a functional single ventricle. The liver is particularly vulnerable to disease including congestion, fibrosis, and even cirrhosis. Currently liver function in the Fontan is not well-characterized and the HepQuant assay could help answer this question.

Detailed description: A novel test called HepQuant® is an assay that has been used to measure liver function in other types of liver disease. In these populations, it is hoped that the assay may show more subtle or sub-clinical liver abnormalities that blood tests alone cannot detect. HepQuant® is a test that examines the ability of the liver to process a substance called cholate, which is a naturally occurring substance in the body. Cholate gets to the liver 2 ways: through the gut (by mouth) or through the blood (IV or intravenous). The test involves administering oral and IV cholate which is labeled. This label is NOT radioactive, but can act as an indicator/marker for evaluation purposes.

The purpose of this study is to develop a reliable means of measuring liver function in the Fontan survivor by examining cholate clearance. The investigators aim to 1) explore any association between level of cholate clearance and measurement of heart and liver function and 2) determine whether cholate clearance can predict clinical outcomes such as heart failure, ascites (development of fluid in the abdomen which can result from heart failure or liver failure), and need for heart transplant.

Eligibility criteria: Inclusion Criteria:

* s/p Fontan operation
* cardiac catheterization or cardiac MRI within 1 year of enrollment

Exclusion Criteria:

* pregnant or breastfeeding
* unable to comprehend and/or give informed consent
* sensitivity to human serum albumin, or its preparations

Primary outcomes:
measure: Hepatic cholate clearance
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Incidence of adverse clinical outcomes
timeFrame: 5 years after cholate assay
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Yuli Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital of the University of Pennslyvania
name: Maarouf Hoteit, MD
role: PRINCIPAL_INVESTIGATOR
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