Cholate Clearance in Fontans
Development of a Reliable Means for Functional Assessment of Liver Performance After the Fontan Operation: Dual Cholate Clearance Assay
HepQuant is an assay to measure liver function in other forms of liver disease such as hepatitis C. It measures the ability of the liver to process an naturally occurring substance called cholate and has been shown to predict clinical outcomes in some patient populations.
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.
研究概览
详细说明
A novel test called HepQuant® is an assay that has been used to measure liver function in other types of liver disease. In these populations, it is hoped that the assay may show more subtle or sub-clinical liver abnormalities that blood tests alone cannot detect. HepQuant® is a test that examines the ability of the liver to process a substance called cholate, which is a naturally occurring substance in the body. Cholate gets to the liver 2 ways: through the gut (by mouth) or through the blood (IV or intravenous). The test involves administering oral and IV cholate which is labeled. This label is NOT radioactive, but can act as an indicator/marker for evaluation purposes.
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Hospital of the University of Pennsylvania
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- s/p Fontan operation
- cardiac catheterization or cardiac MRI within 1 year of enrollment
Exclusion Criteria:
- pregnant or breastfeeding
- unable to comprehend and/or give informed consent
- sensitivity to human serum albumin, or its preparations
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Fontan patient
Cholate assay will be administered once to Fontan patients and blood specimens will be collected to analyze cholate clearance.
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Labeled oral and IV cholate will be administered once to the Fontan cohort and blood specimens will be collected at baseline and timepoints thereafter.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hepatic cholate clearance
大体时间：Through study completion, an average of 1 year
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D4-cholate and 13C-cholate clearance
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Through study completion, an average of 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of adverse clinical outcomes
大体时间：5 years after cholate assay
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combined outcome of occurrence of any of the following: heart failure admission, clinically significant ascites, protein losing enteropathy, referral for cardiac transplantation, death
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5 years after cholate assay
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合作者和调查者
调查人员
- 首席研究员：Yuli Kim, MD、University of Pennsylvania
- 首席研究员：Maarouf Hoteit, MD、Hospital of the University of Pennslyvania
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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