Cholate clearance testing for adults with Fontan circulation or right-sided heart failure
Hepatic Perfusion and Liver Health as Assessed by Dual Cholate Clearance Assay in Fontan-associated Liver Disease (FALD)
This trial will test whether the HepQuant dual cholate clearance blood test can measure liver function in adults with Fontan circulation or right-sided heart failure compared with healthy controls.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HepQuant, LLC Industry-sponsored |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07009132 on ClinicalTrials.gov |
What this trial studies
Researchers will perform the HepQuant dual cholate clearance assay and a cardiac MRI at baseline in three groups: adults with Fontan circulation, adults with right-sided heart failure (non-Fontan), and healthy controls. Results will be compared to determine how impaired hepatic blood flow relates to liver function in Fontan patients versus right heart failure and normal hearts. The study will track participants' health status and clinical outcomes for five years to see if cholate clearance predicts progression or complications. This is an observational protocol conducted at the Hospital of the University of Pennsylvania with standardized imaging and biochemical measurements.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with Fontan circulation who had right heart catheterization in the past year, adults with two‑ventricle anatomy and estimated CVP ≥8 mmHg with normal LVEF for the right‑heart failure group, or healthy adults with normal cardiac anatomy and low CVP for the control group.
Not a fit: Patients who are pregnant or breastfeeding, unable to give informed consent, allergic to human serum albumin, have extensive small‑bowel resection or severe gastroparesis, or are taking nonselective beta blockers or ACE inhibitors are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the HepQuant cholate clearance test could offer a reliable, noninvasive way to detect and monitor Fontan-associated liver disease and help predict future clinical problems.
How similar studies have performed: HepQuant cholate clearance has shown usefulness in other chronic liver diseases, but applying it specifically to Fontan-associated liver disease and right-heart failure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.