Surrogate Markers of Portal Pressure

Completed · Not applicable

Conditions studied: Portal Hypertension, Cirrhosis

In brief

This is a prospective longitudinal study that will evaluate if changes (pre and post therapy) in indocyanine green (ICG) retention test and liver stiff ness (LS) and spleen stiffness (SS) as measured by acoustic radiofrequency impulse (ARFI) correlate with changes in portal pressure as determined by the hepatic vein pressure gradient (HVPG) in patients with compensated hepatitis C virus (HCV) cirrhosis undergoing antiviral therapy.

Key facts

Study ID

NCT02508298

Run by

VA Connecticut Healthcare System

People needed

41

Starts

2014-04-01

Expected to finish

2019-07-01

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-85
• HCV infection (HCV-RNA positive)
• Compensated cirrhosis will be defined histologically and/or clinically (presence of compatible lab findings (platelet count ≤ 150,000, total bilirubin ≥ 2, serum albumin ≤ 3.5, INR ≥ 1.2) PLUS compatible physical exam features (cutaneous stigmata, gynecomastia in men, or splenomegaly) OR compatible radiological findings (nodular liver surface, splenomegaly, and/or collaterals). (The ultimate confirmation of the diagnosis of cirrhosis will be a baseline HVPG > 5 mmHg)
• Planned anti-HCV therapy in the next 3 months

You may not qualify if…

• Any clinically-evident complication of cirrhosis that defines decompensation : jaundice, ascites, variceal hemorrhage, overt hepatic encephalopathy)
• Hepatocellular carcinoma
• Co-infection with HBV or HIV
• Ongoing alcohol abuse
• Occlusive portal thrombosis,
• Presence of comorbid conditions conferring a life expectancy<1 year, history of allergy to iodides, pregnancy

Where it is running

• Yale-New Haven Hospital — New Haven, Connecticut, United States
• VA Connecticut Healthcare System — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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