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Liver Function Test in People with Fontan Circulation or Heart Failure

Tests a liver function assay in Fontan patients and heart failure patients over 5 years.

Key facts

Who runs it
HepQuant, LLC
Where
Philadelphia, United StatesSee the site
Trial code
Registry title
Cholate Clearance in Fontan and Heart Failure
Status
Recruiting
People taking part
75 people, planned
Started
4 Aug 2025
Expected to end
Dec 2031
Type of study
Observational, 3 groups
Treatments tested
  • Dual cholate clearance assay
  • MRI
Record updated
17 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have had a Fontan operation, plus two comparison groups: adults with right heart failure and healthy adults. All have a liver function test and a heart MRI.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Fontan group: adults with a Fontan who had a right heart catheterization within the past 1 year. Right heart failure group: two-ventricle heart with a normal-working left ventricle (function 50% or more) and CVP estimate 8 mmHg or more. Healthy group: normal heart structure and function.
Earlier treatment
Fontan group: right heart catheterization within the past 1 year. Right heart failure and healthy groups: an echocardiogram within the past 1 year.
Biomarker or test result
Right heart failure group: CVP estimate 8 mmHg or more. Healthy group: CVP estimate under 5 mmHg.

Main reasons for not taking part

  • Pregnant or breastfeeding
  • Cannot understand or give informed consent
  • Sensitivity to human serum albumin
  • Short gut or severe gastroparesis
  • Cannot have a heart MRI

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Participants with extensive resection of large segments of the small intestine (short gut) or severe gastroparesis
  • 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
  • Sensitivity to human serum albumin, or its preparations
  • 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
  • Pregnant or breastfeeding
  • Unable to comprehend and/or give informed consent

Where in United States

  • Hospital of the University of PennsylvaniaPhiladelphia, United StatesContact: Bella Clinical Research CoordinatorTaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Fontan

    Patients with a Fontan diagnosis who have undergone a right heart catheterization in the past year

    Treatment: Dual cholate clearance assay and MRI

  • Right Heart Failure (RHF) Controls

    Non-Fontan patients with RHF (patients with normal 2-ventricle anatomy who have intermediate or elevated right-sided filling pressures (CVP) by echocardiogram)

    Treatment: Dual cholate clearance assay and MRI

  • Normal Controls

    Patients with normal cardiac anatomy and normal CVP (right-sided filling pressure) by echocardiogram.

    Treatment: Dual cholate clearance assay and MRI

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Hepatic Perfusion and Liver Health as Assessed by Dual Cholate Clearance Assay in Fontan-associated Liver Disease (FALD)
Plain-language title
Liver Function Test in People with Fontan Circulation or Heart FailureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
17 September 2026