Cholate Clearance in Fontan and Heart Failure

This observational study aims to understand liver health in adults with Fontan circulation and those with right heart failure. Researchers are using a special test called the HepQuant dual cholate clearance assay, which measures how well your liver is working. You would receive labeled oral and intravenous cholate, followed by two blood samples over 60 minutes. The study also involves a cardiac MRI (Magnetic Resonance Imaging) scan. The goal is to see if this cholate clearance test can accurately measure liver function in these conditions and predict future health outcomes. You may be eligible if you are an adult (18+) with Fontan circulation who has had a right heart catheterization recently, or a non-Fontan adult with two heart chambers, good left heart function, and a specific CVP estimate. The study plans to enroll 75 participants.

Study design
This is an observational study, meaning researchers will collect information without giving new treatments. It aims to enroll 75 participants.
What's involved
You would undergo a HepQuant dual cholate clearance assay (oral and intravenous cholate, two blood samples) and a cardiac MRI at the start. Your health status will then be tracked for 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will have their health status collected for 5 years after the initial procedures.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07009132

Cholate Clearance in Fontan and Heart Failure

Recruiting
Not specifiedAges 18+Observational
HepQuant, LLC
~75 participants
Updated 2025-09-15 on ClinicalTrials.gov
What's tested:Dual cholate clearance assayMRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hepatic cholate clearance
Measured over Baseline
Fontan
Right Heart Failure
1 sites across 1 states
Pennsylvania1
Bella Clinical Research Coordinator
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Fontan: Adult Fontan patients ≥ 18 years of age who have undergone right heart catheterization within the past 1 year.
RHF Controls: non-Fontan adults with two ventricle anatomy with systemic left ventricle, CVP estimate ≥ 8 mmHg and left ventricle (LV) function ≥ 50% by echocardiogram performed within the past 1 year. Can include those with congenital heart disease- repaired or unrepaired.
Normal Controls: non-Fontan adults with normal cardiac anatomy, normal biventricular function, \< moderate tricuspid regurgitation and CVP estimate \< 5 mmHg by echocardiogram performed within the past 1 year.

Exclusion

Pregnant or breastfeeding
Unable to comprehend and/or give informed consent
Sensitivity to human serum albumin, or its preparations
Participants with extensive resection of large segments of the small intestine (short gut) or severe gastroparesis
Participants on non-selective beta blockers, angiotensin converting-enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), ursodeoxycholic acid, cholic acid, or other bile acids who are unwilling or unable to delay taking their normal dose the morning of their dual cholate clearance testing.
Participants on dietary supplements, bile acid sequestrants, GLP-1 agonists, narcotics, and other medications affecting gastric emptying or intestinal absorption who are unwilling or unable to delay taking or withhold as outlined in the instructions on deviating from the SHUNT test.
Contraindication to cardiac MRI
For RHF and normal controls: diabetes, chronic liver disease, \>moderate alcohol use, BMI \>30, oxygen-dependent, pulmonary hypertension22 on therapy, known porto-pulmonary hypertension
  • Hepatic cholate clearanceBaseline

    13C-cholate and d4-cholate clearance as assessed by the dual cholate clearance test