Cholate Clearance in Fontan and Heart Failure

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.

NCT Number	NCT07009132
Lead Sponsor	HepQuant, LLC Collaborators: University of Pennsylvania
Conditions	Fontan, Right Heart Failure
Enrollment	75 participants
Start Date	2025-08-04
Primary Completion	2026-12 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2025-09-15