Cholate Clearance in Fontans

NCT03726229 | Completed FDA Device

• 1 other identifier: 829578
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fontan Procedure

Keywords

liver disease

Outcome Measures

Primary Outcomes (1)

• Hepatic cholate clearance

  D4-cholate and 13C-cholate clearance

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Incidence of adverse clinical outcomes

  5 years after cholate assay

Study Arms (1)

Fontan patient

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

Device: Cholate assay

Interventions

Cholate assay DEVICE

Labeled oral and IV cholate will be administered once to the Fontan cohort and blood specimens will be collected at baseline and timepoints thereafter.

Also known as: HepQuant assay

Fontan patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Fontan survivors at least 18 years of age

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Kim YY, Nyman A, Huang YS, Tomlinson AZ, McRae MP, Everson GT, Vaikunth S, Rosenthal B, Rychik J, Hoteit MA. Alterations in Liver Perfusion in Adults With Fontan Circulation as Assessed by Dual Cholate Clearance. J Am Heart Assoc. 2025 Apr;14(7):e039479. doi: 10.1161/JAHA.124.039479. Epub 2025 Mar 21.

  PMID: 40118791 DERIVED

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Yuli Kim, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Maarouf Hoteit, MD

  Hospital of the University of Pennslyvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: May 1, 2019
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)