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Cholate Clearance in Fontans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03726229
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : June 18, 2019
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

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

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Fontan patient
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

Primary Outcome Measures :
  1. Hepatic cholate clearance [ Time Frame: Through study completion, an average of 1 year ]
    D4-cholate and 13C-cholate clearance

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Fontan survivors at least 18 years of age

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03726229

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Contact: Yuli Kim, MD 215-615-3388
Contact: Maarouf Hoteit, MD

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United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Yuli Kim, MD    215-615-3388   
Contact: Maarouf Hoteit, MD   
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: University of Pennsylvania Identifier: NCT03726229     History of Changes
Other Study ID Numbers: 829578
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by University of Pennsylvania:
liver disease