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

• Status: Completed
• Trial end date: 2017-02-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver

Criteria

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