Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
75 participants
OBSERVATIONAL
2025-08-04
2031-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Fontan
Patients with a Fontan diagnosis who have undergone a right heart catheterization in the past year
Dual cholate clearance assay
Study participants are administered labeled oral and intravenous cholate, and then two blood samples are taken over 60-minutes. Serum cholate levels are measured by blood draws.
MRI
Unsedated non contrast cardiac magnetic resonance imaging (MRI)
Right Heart Failure (RHF) Controls
Non-Fontan patients with RHF (patients with normal 2-ventricle anatomy who have intermediate or elevated right-sided filling pressures (CVP) by echocardiogram)
Dual cholate clearance assay
Study participants are administered labeled oral and intravenous cholate, and then two blood samples are taken over 60-minutes. Serum cholate levels are measured by blood draws.
MRI
Unsedated non contrast cardiac magnetic resonance imaging (MRI)
Normal Controls
Patients with normal cardiac anatomy and normal CVP (right-sided filling pressure) by echocardiogram.
Dual cholate clearance assay
Study participants are administered labeled oral and intravenous cholate, and then two blood samples are taken over 60-minutes. Serum cholate levels are measured by blood draws.
MRI
Unsedated non contrast cardiac magnetic resonance imaging (MRI)
Interventions
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Dual cholate clearance assay
Study participants are administered labeled oral and intravenous cholate, and then two blood samples are taken over 60-minutes. Serum cholate levels are measured by blood draws.
MRI
Unsedated non contrast cardiac magnetic resonance imaging (MRI)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
HepQuant, LLC
INDUSTRY
Responsible Party
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Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Facility Contacts
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Other Identifiers
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Fontan Cholate 2.0
Identifier Type: -
Identifier Source: org_study_id
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