Recruiting

HepQuant Assay

Sponsor:

HepQuant, LLC

Code:

NCT07009132

Conditions

Fontan

Right Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dual cholate clearance assay

MRI

Study Details

Brief 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.

Conditions

Fontan

Right Heart Failure

Study ID

NCT07009132

Start date

Aug 4, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

Fontan

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

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)

Normal Controls

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

Interventions

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.

MRI

Unsedated non contrast cardiac magnetic resonance imaging (MRI)

Primary outcome measure

  • Hepatic cholate clearance [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Bella Clinical Research Coordinator

215-615-3388Isabella.Farkas@Pennmedicine.upenn.edu

Principal Investigator:

Yuli Kim, MD

More Information

Sponsor

HepQuant, LLC

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by HepQuant, LLC on 2025-09-15.