Surrogate Markers of Portal Pressure
1 other identifier
interventional
41
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
July 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedNovember 25, 2019
November 1, 2019
4.3 years
January 9, 2015
November 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Indocyanine Green before and after treatment of hepatitis c
Indocyanine Green will be obtained , this will be conducted before and after treatment for hepatitis c and is measured in mg/dl
2 years
Secondary Outcomes (3)
Spleen stiffness before and after treatment of hepatitis c
2 years
Liver stiffness before and after treatment of hepatitis c
2 years
Hepatic venous pressure gradient before and after treatment of hepatitis c
2 years
Study Arms (3)
Indocyanine green retention test
ACTIVE COMPARATORA baseline venous sample of 5 ml of venous will be drawn for pre-infusion measurement. Under sterile conditions 0.5 mg/kg body weight of ICG will be injected into vein. Further blood samples (5 ml each) will be collected at 5, 10, 15 and 20 minute intervals after the injection from a peripheral vein in the opposite arm using another intravenous catheter. After serum is separated by centrifugation, optical densities will be measured at 804 nm using a calibrated method for measurement of ICG level s. ICG retention at 15 minutes and elimination rate constant will be calculated by fitting the serum disappearance curve to a single exponential decay equation.This will be compared to portal pressure measured by Hepatic Venous Portal Gradient (HVPG).
Liver stiffness measurement
ACTIVE COMPARATORARFI measurements of the liver will be obtained using a standard ultrasound probe. The patient will be lying on his back and will be asked to hold his/her breath for 2-5 seconds during measurements.These will be compared to portal pressure measured by Hepatic Venous Portal Gradient (HVPG).
Spleen stiffness measurement
ACTIVE COMPARATORARFI measurements of the spleen will be obtained using a standard ultrasound probe. The patient will be lying on his back and will be asked to hold his/her breath for 2-5 seconds during measurements.These will be compared to portal pressure measured by Hepatic Venous Portal Gradient (HVPG).
Interventions
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.
As decribed in arm descriptions
As decribed in arm descriptions; perfromed by ARFI
As decribed in arm descriptions; performed by ARFI
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Yale-New Haven Hospital
New Haven, Connecticut, 06511, United States
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guadalupe Garcia-Tsao, MD
VA Connecticut Healthcare System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2015
First Posted
July 24, 2015
Study Start
April 1, 2014
Primary Completion
July 1, 2018
Study Completion
July 1, 2019
Last Updated
November 25, 2019
Record last verified: 2019-11