Cholate Clearance in Fontans

Completed

• Conditions: Fontan Procedure
• Interventions: Device: Cholate assay

• Registration Number: NCT03726229
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-10-31
• Study Start: 2019-05-01
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fontan patient	Cholate assay	Cholate assay will be administered once to Fontan patients and blood specimens will be collected to analyze cholate clearance.

Primary Outcome Measures

Name	Time	Method
Hepatic cholate clearance	Through study completion, an average of 1 year	D4-cholate and 13C-cholate clearance

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States