Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)



Status:Suspended
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:12/29/2018
Start Date:March 2016
End Date:August 2019

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This study plans to learn more about a new test to look at liver function, the HepQuant-Shunt
(HQ-Shunt). The HQ-Shunt is being evaluated for safety and effectiveness as an alternative to
Hepatic Venous Pressure Gradient testing in patients with liver disease.

The goal of this study is to demonstrate the HQ-SHUNT is safe, simple to administer,
noninvasive, cost-effective, and well tolerated by patients. This study will compare the
HQ-SHUNT to Hepatic Venous Pressure Gradient (HVPG) testing. In this study, 100 consecutive
patients with various etiologies of liver disease who have undergone technically successful
HVPG testing as standard of care will also undergo HQ-SHUNT testing.

Inclusion Criteria:

- Liver disease patient scheduled to have an Hepatic Venous Pressure Gradient (HVPG)
procedure

- At time of enrollment, being between the ages of 18 and 75

Exclusion Criteria:

- Concomitant treatment with both a beta blocker and an ACE inhibitor

- Concurrent hepatic malignancy. Patients with a history of treated HCC can be included
if there is no evidence of recurrent disease at the time of this study.

- Unstable angina or history of myocardial infarction or congestive heart failure within
6 months prior to enrollment into this study

- Renal insufficiency with chronic kidney disease stage 4 or 5 (GFR < 30 mL/min/1.73m2)

- Crohn's disease or any active intestinal inflammatory condition

- Having had an ileal resection

- Diabetic Gastroparesis

- Pregnancy or intent to become pregnant. Urine pregnancy tests will be performed prior
to HQ SHUNT testing.

- Inability to consent for one's self
We found this trial at
1
site
12401 East 17th Avenue
Aurora, Colorado 80045
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from
Aurora, CO
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