Cholate Clearance in Fontan and Heart Failure

NCT07009132 | Recruiting FDA Device

• 1 other identifier: Fontan Cholate 2.0
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Hepatic cholate clearance

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

  Baseline

Secondary Outcomes (1)

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

  5 years after first cholate assay

Study Arms (3)

Fontan

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

Device: Dual cholate clearance assay; Radiation: 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)

Device: Dual cholate clearance assay; Radiation: MRI

Normal Controls

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

Device: Dual cholate clearance assay; Radiation: MRI

Interventions

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.

Also known as: HepQuant dual cholate clearance assay

Fontan; Normal Controls; Right Heart Failure (RHF) Controls

MRI RADIATION

Unsedated non contrast cardiac magnetic resonance imaging (MRI)

Fontan; Normal Controls; Right Heart Failure (RHF) Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible Fontan participants will be identified by screening the Fontan database for patients who have undergone cardiac catheterization in the past year and by searching the outpatient clinic schedule. Eligible RHF and normal control participants will be screened through the outpatient echo lab schedule at Hospital of the University of Pennsylvania.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HepQuant, LLC: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 6, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)