Cholate Clearance in Fontans
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/27/2019 |
| Start Date: | March 2019 |
| End Date: | March 2024 |
| Contact: | Yuli Kim, MD |
| Email: | yuli.kim@uphs.upenn.edu |
| Phone: | 215-615-3388 |
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.
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.
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.
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.
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
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Phone: 215-615-3388
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
Click here to add this to my saved trials
