RecruitingNCT07009132

Cholate Clearance in Fontan and Heart Failure

Hepatic Perfusion and Liver Health as Assessed by Dual Cholate Clearance Assay in Fontan-associated Liver Disease (FALD)

Sponsor

HepQuant, LLC

Enrollment

75 participants

Start Date

Aug 4, 2025

Study Type

OBSERVATIONAL

Conditions

Right Heart Failure Fontan

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how well the liver clears bile acids (called cholates) in people with a special heart condition called Fontan circulation, and comparing them to people with regular heart failure and healthy adults. Fontan patients have a uniquely structured heart that affects blood flow through the liver. **You may be eligible if...** - You are an adult (18+) who has had Fontan surgery and had a right heart catheterization in the past year - OR you are an adult with regular heart failure and preserved heart pumping function with elevated pressure in your veins - OR you are a healthy adult with normal heart anatomy and normal heart function **You may NOT be eligible if...** - You have active liver disease or cirrhosis (beyond what is expected in Fontan patients) - You have kidney disease requiring dialysis - You have conditions that could affect the test results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDual 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.

RADIATIONMRI

Unsedated non contrast cardiac magnetic resonance imaging (MRI)