Actively Recruiting
Hepatic Perfusion and Liver Health Assessed by Dual Cholate Clearance in Fontan-associated Liver Disease
Led by HepQuant, LLC · Updated on 2025-09-15
75
Participants Needed
1
Research Sites
260 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
Researchers are studying liver function in adults with Fontan-associated liver disease (FALD) by using the HepQuant dual cholate clearance assay. The study aims to understand how impaired blood flow affects liver health in people with Fontan circulation compared to those with right heart failure and healthy individuals. They also want to see if cholate clearance can predict important health outcomes in this group. Participants will be grouped into three categories: adults with Fontan diagnosis who recently had right heart catheterization, adults with right heart failure but normal two-ventricle anatomy, and healthy adults with normal heart anatomy and function. All participants will undergo the dual cholate clearance assay, which involves taking labeled cholate orally and intravenously, followed by blood samples to measure serum cholate levels. They will also have a non-contrast cardiac MRI without sedation at the start of the study. After these initial tests, researchers will collect health information over five years to monitor outcomes related to heart and liver health. The primary measure is hepatic cholate clearance at baseline. The study includes healthy volunteers aged 18 and older and involves assessments like echocardiograms, cardiac MRI, blood tests, and ongoing clinical monitoring. This long-term follow-up will help evaluate the usefulness of cholate clearance in assessing liver disease severity and predicting clinical events.
CONDITIONS
Brief Title
Cholate Clearance in Fontan and Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with Fontan diagnosis who have had right heart catheterization within the past year
- Adults with right heart failure and two ventricle anatomy with systemic left ventricle, CVP estimate 2 8 mmHg, and left ventricle function 2 50% by echocardiogram within the past year
- Adults with normal cardiac anatomy, normal biventricular function, less than moderate tricuspid regurgitation, and CVP estimate less than 5 mmHg by echocardiogram within the past year
You will not qualify if you...
- Pregnant or breastfeeding
- Unable to understand or give informed consent
- Sensitivity to human serum albumin or its preparations
- Extensive removal of large parts of the small intestine or severe gastroparesis
- Use of certain medications affecting bile acids or gastric emptying who cannot delay or withhold them on test day
- Contraindication to cardiac MRI
- For right heart failure and normal controls: having diabetes, chronic liver disease, heavy alcohol use, BMI over 30, oxygen dependence, pulmonary hypertension on therapy, or known porto-pulmonary hypertension
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo dual cholate clearance assays involving labeled oral and intravenous cholate administration with blood draws, and unsedated non-contrast cardiac MRI to assess hepatic perfusion and liver health.
1 visit (in-person)
Duration - Up to 5 years
Participants are monitored for heart or liver-related clinical outcomes following the initial diagnostic evaluation.
Periodic follow-up visits over 5 years
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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