Actively Recruiting
Cholate Clearance in Fontan and Heart Failure
Led by HepQuant, LLC · Updated on 2025-09-15
75
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
Sponsors
H
HepQuant, LLC
Lead Sponsor
U
University of Pennsylvania
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Cholate Clearance in Fontan and Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult Fontan patients aged 18 years or older who have had right heart catheterization within the past year
- Non-Fontan adults with two ventricle anatomy, systemic left ventricle, CVP estimate ≥ 8 mmHg, and left ventricle function ≥ 50% by recent echocardiogram for right heart failure controls
- Non-Fontan adults with normal cardiac anatomy, normal biventricular function, less than moderate tricuspid regurgitation, and CVP estimate less than 5 mmHg by recent echocardiogram for normal controls
You will not qualify if you...
- Pregnant or breastfeeding
- Unable to understand or provide informed consent
- Sensitivity to human serum albumin or its preparations
- Extensive resection of large segments of the small intestine (short gut) or severe gastroparesis
- Taking non-selective beta blockers, ACE inhibitors, ARBs, ursodeoxycholic acid, cholic acid, or other bile acids and unwilling or unable to delay dose on test day
- Taking dietary supplements, bile acid sequestrants, GLP-1 agonists, narcotics, or medications affecting gastric emptying or absorption and unwilling or unable to delay or withhold as instructed
- Contraindication to cardiac MRI
- For right heart failure and normal controls: diabetes, chronic liver disease, more than moderate alcohol use, BMI over 30, oxygen dependence, pulmonary hypertension on therapy, or known porto-pulmonary hypertension
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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