Fontan Procedure Clinical Trial
Official title:
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05063903 -
Exercise Capacity in Patients With Fontan Procedure
|
||
| Terminated |
NCT01107990 -
Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
|
||
| Not yet recruiting |
NCT06193863 -
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
|
||
| Completed |
NCT00974025 -
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
|
N/A | |
| Completed |
NCT02237274 -
Cardiopulmonary Adaptation of Short Term Exposure to High Altitude in Fontan Patients: Swiss Fontan & ALtitude COllaboratioN (FALCON) Study
|
N/A | |
| Completed |
NCT05011565 -
Hemodynamic, Vascular and Muscular Parameters of Exercise Capacity in Single-Ventricle Patients With Fontan Procedure
|
||
| Recruiting |
NCT05684562 -
Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients
|
||
| Terminated |
NCT02966002 -
Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
|
Phase 4 | |
| Completed |
NCT03503032 -
Clinical Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles
|