Cholate Clearance in Fontan and Heart Failure

Launched by HEPQUANT, LLC · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Cholate Clearance in Fontan and Heart Failure," is focused on understanding how liver function is affected in patients who have undergone the Fontan procedure for congenital heart defects, as well as those with right heart failure. The researchers will use a special test called the HepQuant dual cholate clearance assay to measure liver function and see if it can help predict health outcomes for these patients. By comparing Fontan patients with those who have right heart failure and healthy individuals, the study aims to learn more about the impact of blood flow to the liver.

To participate in this study, you must be at least 18 years old and meet specific criteria. For example, Fontan patients should have had a certain heart test within the past year, while those with right heart failure need to have a functioning left ventricle. Healthy participants will also be included if they have normal heart function. If you join the trial, you will undergo the cholate clearance test and an MRI of the heart at the start. After that, your health status will be monitored for five years. It's important to note that some individuals, such as those who are pregnant or have certain medical conditions, may not be eligible to participate.

Gender

ALL

Eligibility 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