Cholate Clearance in Fontan and Heart Failure

Not yet recruiting

• Conditions: Fontan; Right Heart Failure

• Registration Number: NCT07009132
• Lead Sponsor: HepQuant, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-29
• Study First Posted: 2025-06-06
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-15
• Primary Completion: 2026-12
• Study Completion: 2031-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hepatic cholate clearance	Baseline	13C-cholate and d4-cholate clearance as assessed by the dual cholate clearance test

Secondary Outcome Measures

Name	Time	Method
Occurrence of at Least One Heart or Liver-Related Clinical Outcome	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.

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States