hepatomiR cACLD Study

Recruiting

• Conditions: Portal Hypertension; Chronic Liver Disease; Chronic Liver Disease and Cirrhosis
• Interventions: Diagnostic Test: hepatomiR

• Registration Number: NCT06432582
• Lead Sponsor: Karl Landsteiner University of Health Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-15
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-24
• Last Update Submitted: 2024-05-24
• Study First Posted: 2024-05-29
• Last Update Posted: 2024-05-29
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• 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 Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cACLD	hepatomiR	Patients with compensated advanced chronic liver disease (cACLD) regardless of etiology

Primary Outcome Measures

Name	Time	Method
Occurrence of any hepatic decompensation event (per patient)	12 months	Any (further) hepatic decompensation event (compound endpoint; Baveno VII definition; ascites, variceal bleeding, hepatic encephalopathy)

Secondary Outcome Measures

Name	Time	Method
Number of hospital admissions (per patient)	12 months
Number and type of individual decompensation events (per patient)	12 months
Number of acute on chronic liver failure events (per patient)	12 months	EF-CLIF (European Association for the Study of the Liver - Chronic Liver Failure) definition, CLIF-C (chronic liver failure score) ACLF (acute on chronic liver failure) grading
Development of hepatocellular cancer or cholangiocarcinoma (per patient)	12 months
Number of deaths	12 months
Number of ICU (intensive care unit) admissions (per patient)	12 months

Trial Locations

Locations (1)

University Hospital St. Pölten; 🇦🇹 St. Pölten, Lower Austria, Austria