Cholate Clearance in Fontans

Development of a Reliable Means for Functional Assessment of Liver Performance After the Fontan Operation: Dual Cholate Clearance Assay

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.

Study Overview

• Status: Completed
• Conditions: Fontan Procedure
• Intervention / Treatment: Device: Cholate assay

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult Fontan survivors at least 18 years of age

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fontan patient; Cholate assay will be administered once to Fontan patients and blood specimens will be collected to analyze cholate clearance.	Device: Cholate assay; Labeled oral and IV cholate will be administered once to the Fontan cohort and blood specimens will be collected at baseline and timepoints thereafter.; Other Names: HepQuant assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic cholate clearance	D4-cholate and 13C-cholate clearance	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse clinical outcomes	combined outcome of occurrence of any of the following: heart failure admission, clinically significant ascites, protein losing enteropathy, referral for cardiac transplantation, death	5 years after cholate assay

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Yuli Kim, MD, University of Pennsylvania; Principal Investigator: Maarouf Hoteit, MD, Hospital of the University of Pennslyvania

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: liver disease
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cholic Acids
• Other Study ID Numbers: 829578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes