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Cholate Clearance in Fontans

NCT03726229 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-06-10

No results posted yet for this study

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.

Conditions

  • Fontan Procedure

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Yuli Kim, MD · University of Pennsylvania

  • Maarouf Hoteit, MD · Hospital of the University of Pennslyvania

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2022-05-25
Completion
2022-05-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03726229 on ClinicalTrials.gov