Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07009132

Cholate Clearance in Fontan and Heart Failure

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Fontan Cardiovascular Diseases Heart Diseases Heart Failure Right Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Bella Clinical Research Coordinator

CONTACT

[email protected]

215-615-3388

Yuli Kim, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual cholate clearance assay

Device

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.

Other names: HepQuant dual cholate clearance assay

MRI

Radiation

Unsedated non contrast cardiac magnetic resonance imaging (MRI)

Primary outcomes

  1. Hepatic cholate clearance

    Time frame: Baseline

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

Secondary outcomes

  1. Occurrence of at Least One Heart or Liver-Related Clinical Outcome

    Time frame: 5 years after first cholate assay

    A patient will be considered to have a heart or liver-related clinical outcome if any of the following occur within 5 years after the first cholate assay: new-onset heart failure (defined as hospitalization for intravenous diuresis), progressive heart failure (defined as referral for heart or combined heart-liver transplant), clinically significant ascites (defined as requiring large volume paracentesis), new-onset protein-losing enteropathy, hepatocellular carcinoma, heart transplant or a combined heart and liver transplant, or death. Number of subjects with at least one of the above clinical outcomes will be captured and reported for all study groups.

Sponsors and collaborators

Lead sponsor

HepQuant, LLC

Industry

Collaborators

  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2031
First posted
Jun 6, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.