Clinical trial NCT02523196: Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)
Official title: Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Disease
Keywords: Hepatic Venous Pressure Gradient (HVPG) testing
HepQuant-SHUNT
Liver Function
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1)
timeFrame: Up to 90 minutes
measure: Results of HepQuant SHUNT Test: Systemic Clearance
timeFrame: Up to 90 minutes
measure: Results of HepQuant SHUNT Test: Apparent Portal Clearance
timeFrame: Up to 90 minutes
measure: Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate
timeFrame: Up to 90 minutes
measure: Results of HepQuant SHUNT Test: Portal Hepatic Filtration Rate
timeFrame: Up to 90 minutes
measure: Results of HepQuant SHUNT Test: SHUNT
timeFrame: Up to 90 minutes
measure: Results of HepQuant SHUNT Test: DSI Score
timeFrame: Up to 90 minutes
measure: Results of HepQuant SHUNT Test: STAT
timeFrame: 60 minutes
Secondary outcomes:
measure: Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.
timeFrame: Immediately post HepQuant SHUNT test (Baseline up to Day 60)
measure: Hours for Test
timeFrame: Baseline, up to Day 60
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver (Leprino Building)
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Amanda Wieland, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Everson GT, Shiffman ML, Hoefs JC, Morgan TR, Sterling RK, Wagner DA, Lauriski S, Curto TM, Stoddard A, Wright EC; HALT-C Trial Group. Quantitative liver function tests improve the prediction of clinical outcomes in chronic hepatitis C: results from the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial. Hepatology. 2012 Apr;55(4):1019-29. doi: 10.1002/hep.24752. Epub 2012 Mar 1.