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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease
Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease
University of Colorado Denver (Leprino Building)
Aurora, Colorado, United States
Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1)
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Time frame: Up to 90 minutes
Results of HepQuant SHUNT Test: Systemic Clearance
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension. Systemic Clearance (13C-CA; ml min-1)
Time frame: Up to 90 minutes
Results of HepQuant SHUNT Test: Apparent Portal Clearance
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Time frame: Up to 90 minutes
Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Time frame: Up to 90 minutes
Results of HepQuant SHUNT Test: Portal Hepatic Filtration Rate
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Time frame: Up to 90 minutes
Results of HepQuant SHUNT Test: SHUNT
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension. SHUNT% is The percent of the oral dose of cholate that escapes hepatic extraction
Time frame: Up to 90 minutes
Results of HepQuant SHUNT Test: DSI Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension. DSI range is from 0 to 50. 0 implies no disease; 50 implies severe end-stage disease.
Time frame: Up to 90 minutes
Results of HepQuant SHUNT Test: STAT
Compare HepQuant STAT test from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension. HepQuant STAT is a simple "drink and draw" blood-based clearance test that quantifies hepatic impairment from early through late stages of disease.
Time frame: 60 minutes
Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.
Overall experience and willingness to repeat 0-10 Scale 0 being no pain, 10 being severe pain 0 being no discomfort, 10 being severe discomfort 0 being no interference with daily life, 10 being unable to carry on activities 0 being very negative experience, 10 being very positive experience 0 being definitely not wanting to have the test again, 10 being very willing to have the test again
Time frame: Immediately post HepQuant SHUNT test (Baseline up to Day 60)
Hours for Test
Number of hours it took for subjects to complete each test
Time frame: Baseline, up to Day 60