RecruitingNCT06432582

hepatomiR cACLD Study

Assessment of a hepatomiR Cut-off for Predicting Specific Hepatic Decompensation Events in Advanced Chronic Liver Disease

Sponsor

Karl Landsteiner University of Health Sciences

Enrollment

156 participants

Start Date

May 15, 2024

Study Type

OBSERVATIONAL

Conditions

Portal Hypertension Chronic Liver Disease and Cirrhosis Chronic Liver Disease

Summary

This study looks to gather data on hepatomiR, a CE-certified test already intended for gauging liver-related outcomes, in order to define a cut-off regarding specific decompensation events (ascites, variceal hemorrhage, hepatic encephalopathy) in chronic liver disease (CLD). Based on these data, it is aimed to advance the current understanding of factors driving decompensation, with potential repercussions for future risk management and therapy.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Age ≥ 18 years
Chronic liver disease (more than 6 months)
LSM ≥ 10 kPa
Outpatient at the Clinical Department of Internal Medicine II, University Hospital St. Pölten
Signed patient consent form

Exclusion Criteria3

Age older than 18 years
Pregnancy
Primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread

Interventions

DIAGNOSTIC_TESThepatomiR

hepatomiR is a CE-certified test intended for gauging liver-related outcomes. It quantifies the levels of hsa-miR-122-5p, hsa-miR-192-5p, and hsa-miR-151a-5p in human plasma samples. A proprietary algorithm is then used to compute a liver function score (hepatomiR p-score).