Skip to main content
OpenTrials
Completed

NCT Number: NCT02508298

Surrogate Markers of Portal Pressure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Portal Hypertension Cirrhosis Digestive System Diseases Disease Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale-New Haven Hospital, New Haven, Connecticut, United States

Loading trial locations.

About this study

Subjects will be recruited from the outpatient setting of the West Haven VA Medical Center and the Yale Liver Clinic. Subjects between 18-85 years of age with compensated cirrhosis due to chronic hepatitis C virus (HCV) infection who will be starting anti-viral therapy to treat HCV within the next 3 months will be eligible for this study. 33 subjects (assuming 10% loss to follow-up) will be recruited and their participation will last from 6-12 months. The expected duration of the study is 2 years.

The primary end point of the study is to correlate the change (from baseline to after completing anti-HCV therapy) in ICG retention test, LS and SS as measured by ARFI with HVPG. After consent has been obtained, subjects will undergo ICG retention test, ARFI imaging and HVPG measurements before and after HCV therapy. Blood samples, demographic and clinical data will be collected before and after HCV therapy. Correlations between changes in HVPG and changes in ICG, LS and SS will be assessed. With 30 patients , we will have 80% power to perform a hypothesis test of the Pearson correlation assuming an observed correlation of 0.70 and a two-sided type I error rate of 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

HVPG

Procedure

HVPG will be performed by placing a placing a 7F venous catheter into a supra-hepatic vein and then advancing a 5F balloon-tipped catheter into the right hepatic vein. Wedged hepatic venous pressure (WHVP) and free hepatic venous pressure (FHVP) will be measured by connection to an external transducer and polygraph (PowerLab, ADInstruments Inc., Colorado Springs, CO). After inflating the balloon catheter, adequacy of the occlusion will be established by injection of a small amount of radiologic contrast medium. Hepatic Venous Pressure gradient (HVPG) will be calculated as the difference between WHVP and FHVP.

Other names: Hepatic Venous Portal Gradient

Indocyanine Green Retention test

Drug

As decribed in arm descriptions

Other names: ICG test

Liver stiffness measurement

Device

As decribed in arm descriptions; perfromed by ARFI

Other names: LS

Spleen stiffness measurement

Device

As decribed in arm descriptions; performed by ARFI

Other names: SS

Primary outcomes

  1. Indocyanine Green before and after treatment of hepatitis c

    Time frame: 2 years

    Indocyanine Green will be obtained , this will be conducted before and after treatment for hepatitis c and is measured in mg/dl

Secondary outcomes

  1. Spleen stiffness before and after treatment of hepatitis c

    Time frame: 2 years

    Spleen stiffness will be obtained by ARFI, this will be conducted before and after treatment for hepatitis c and is measured in m/sec

  2. Liver stiffness before and after treatment of hepatitis c

    Time frame: 2 years

    Liver stiffness will be obtained by ARFI, this will be conducted before and after treatment for hepatitis c and is measured in m/sec

  3. Hepatic venous pressure gradient before and after treatment of hepatitis c

    Time frame: 2 years

    Hepatic venous pressure gradient would be obtained by catheterization of the hepatic vein, this will be conducted before and after treatment for hepatitis c and is measured in mmHg

Sponsors and collaborators

Lead sponsor

VA Connecticut Healthcare System

Fed

Registry information

Official study title

Surrogate Markers of Portal Pressure and Changes in Portal Pressure in Patients With Compensated Cirrhosis Undergoing Anti-viral Therapy

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jul 24, 2015
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.