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Cholate Clearance in Fontan and Heart Failure
Sponsor: HepQuant, LLC
Summary
The goal of this study is to use the HepQuant dual cholate clearance assay, which has been shown to measure liver function in people with known chronic liver conditions, to assess severity of Fontan-associated liver disease (FALD). This study aims to understand the role impaired blood flow to the liver plays in liver function in Fontan patients compared to patients with right heart failure and healthy controls. The study will also determine whether cholate clearance is a good measure to use in this population, and whether it will be able to predict clinical outcomes. Participants will undergo a HepQuant dual cholate clearance assay and a cardiac magnetic resonance imaging (MRI) at the beginning of the study, and then data on health status will be collected for 5 years.
Official title: Hepatic Perfusion and Liver Health as Assessed by Dual Cholate Clearance Assay in Fontan-associated Liver Disease (FALD)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
75
Start Date
2025-08-04
Completion Date
2031-12
Last Updated
2025-09-15
Healthy Volunteers
Yes
Conditions
Interventions
Dual cholate clearance assay
Study participants are administered labeled oral and intravenous cholate, and then two blood samples are taken over 60-minutes. Serum cholate levels are measured by blood draws.
MRI
Unsedated non contrast cardiac magnetic resonance imaging (MRI)
Locations (1)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States