Cholate Clearance in Fontans
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|ClinicalTrials.gov Identifier: NCT03726229|
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : June 18, 2019
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.
|Condition or disease||Intervention/treatment|
|Fontan Procedure||Device: Cholate assay|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Development of a Reliable Means for Functional Assessment of Liver Performance After the Fontan Operation: Dual Cholate Clearance Assay|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2024|
Cholate assay will be administered once to Fontan patients and blood specimens will be collected to analyze cholate clearance.
Device: 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 Name: HepQuant assay
- Hepatic cholate clearance [ Time Frame: Through study completion, an average of 1 year ]D4-cholate and 13C-cholate clearance
- Incidence of adverse clinical outcomes [ Time Frame: 5 years after cholate assay ]combined outcome of occurrence of any of the following: heart failure admission, clinically significant ascites, protein losing enteropathy, referral for cardiac transplantation, death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726229
|Contact: Yuli Kim, MDfirstname.lastname@example.org|
|Contact: Maarouf Hoteit, MDemail@example.com|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Yuli Kim, MD 215-615-3388 firstname.lastname@example.org|
|Contact: Maarouf Hoteit, MD email@example.com|