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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COMPLETED
50 participants
OBSERVATIONAL
2019-05-01
2022-05-25
Brief Summary
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The Fontan survivor is a patient who has undergone surgery or a series of surgeries that result in a functional single ventricle. The liver is particularly vulnerable to disease including congestion, fibrosis, and even cirrhosis. Currently liver function in the Fontan is not well-characterized and the HepQuant assay could help answer this question.
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Detailed Description
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The purpose of this study is to develop a reliable means of measuring liver function in the Fontan survivor by examining cholate clearance. The investigators aim to 1) explore any association between level of cholate clearance and measurement of heart and liver function and 2) determine whether cholate clearance can predict clinical outcomes such as heart failure, ascites (development of fluid in the abdomen which can result from heart failure or liver failure), and need for heart transplant.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Fontan patient
Cholate assay will be administered once to Fontan patients and blood specimens will be collected to analyze cholate clearance.
Cholate assay
Labeled oral and IV cholate will be administered once to the Fontan cohort and blood specimens will be collected at baseline and timepoints thereafter.
Interventions
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Cholate assay
Labeled oral and IV cholate will be administered once to the Fontan cohort and blood specimens will be collected at baseline and timepoints thereafter.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* cardiac catheterization or cardiac MRI within 1 year of enrollment
Exclusion Criteria
* unable to comprehend and/or give informed consent
* sensitivity to human serum albumin, or its preparations
18 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Yuli Kim, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Maarouf Hoteit, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital of the University of Pennslyvania
Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Kim YY, Nyman A, Huang YS, Tomlinson AZ, McRae MP, Everson GT, Vaikunth S, Rosenthal B, Rychik J, Hoteit MA. Alterations in Liver Perfusion in Adults With Fontan Circulation as Assessed by Dual Cholate Clearance. J Am Heart Assoc. 2025 Apr;14(7):e039479. doi: 10.1161/JAHA.124.039479. Epub 2025 Mar 21.
Other Identifiers
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829578
Identifier Type: -
Identifier Source: org_study_id
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