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Cholate Clearance in Fontan and Heart Failure

HepQuant, LLC · with University of Pennsylvania · NCT07009132

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
75
US sites recruiting
1
Study start
August 4, 2025
Record last updated
September 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Dual cholate clearance assay; MRI

Conditions: Fontan; Right Heart Failure

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Hospital of the University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Bella Clinical Research Coordinator · 215-615-3388 · Isabella.Farkas@Pennmedicine.upenn.edu

All heart & blood pressure studies in Pennsylvania →
Cholate Clearance in Fontan and Heart Failure (NCT07009132) | Bored Studies