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RECRUITING
NCT07009132

Cholate Clearance in Fontan and Heart Failure

Sponsor: HepQuant, LLC

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

RADIATION

MRI

Unsedated non contrast cardiac magnetic resonance imaging (MRI)

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States