Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease

Launched by CHINESE UNIVERSITY OF HONG KONG · Jun 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called carvedilol, which is a type of non-selective beta-blocker, in patients who have advanced chronic liver disease with a condition known as portal hypertension. The main goal is to find out if taking carvedilol can help prevent serious liver problems and reduce the risk of death in patients who don’t have significant varices (abnormal blood vessels in the esophagus that can bleed) requiring treatment.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of chronic liver disease due to conditions like alcohol-related liver disease, chronic hepatitis B or C, or metabolic liver disease. Participants will be randomly assigned to either take carvedilol or not take it for five years, with regular check-ups that include blood tests and liver scans. This trial is currently recruiting participants, and it’s important for those interested to discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18 years of above
• • Established diagnosis of chronic liver disease(s) of the following etiologies
• • Alcohol-related liver disease (ARLD)
• • Chronic hepatitis B (CHB)
• • Chronic hepatitis C (CHC)
• • Metabolic dysfunction-associated steatotic liver disease (MASLD) § Non-obese (BMI \<30kg/m2) and obese (BMI ≥30 kg/m2)
• • In high-risk grey zone or CSPH, by Baveno VII criteria (for ARLD, CHB, CHC and non-obese MASLD) or ANTICIPATE-NASH model (for obese MASLD) within 6 months from screening
• • Baveno VII criteria (for ARLD, CHB, CHC and non-obese MASLD)
• • LSM ≥25 kPa (CSPH)
• • LSM ≥20 kPa - \<25 kPa and platelet count \<150 x 10\^9/L; or LSM ≥15 kPa - \<20 kPa and platelet count \<110 x 10\^9/L (high-risk grey zone)
• • ANTICIPATE-NASH model (for obese MASLD)
• • Predictive probability for CSPH \>90% (CSPH)
• • Predictive probability for CSPH ≥60% - \<90% (high-risk grey zone)
• Exclusion Criteria:
• • Presence of high-risk varices (HRV) (i.e. moderate to large oesophageal varices \[OV\] or OV with red wale sign) found in OGD
• • Current use of non-selective beta-blocker (NSBB) or any use of NSBB within 6 months before
• • Use of selective beta blocker, such as atenolol or metoprolol, is not excluded
• • Selective beta-blocker will be switched to carvedilol in NSBB arm, and will be kept unchanged in conventional arm if there is clinical need for the selective beta-blocker
• • Contraindication to NSBB (e.g. Type II/III heart block or baseline bradycardia \<60/minute, hypotension with systolic blood pressure (SBP) \<100 mmHg, asthma, poorly controlled chronic obstructive pulmonary disease, and peripheral vascular disease)
• • Current use of nitrated drugs or any use of nitrated drugs within 6 months before
• • o Use of sublingual nitrate, such as glyceryl trinitrate, is not excluded
• • Contraindication to OGD (e.g. Intestinal perforation or obstruction)
• • Current or history of decompensated liver cirrhosis (i.e. Child's C cirrhosis, prior decompensating events such as ascites, variceal bleeding, hepatic encephalopathy and hepatorenal syndrome)
• • o Child's B cirrhosis without decompensating events is not excluded
• • Current or history of hepatocellular carcinoma (HCC)
• • Current or history of portal vein thrombosis
• • Transjugular intrahepatic portosystemic shunt (TIPS)
• • Liver transplantation
• • Serious medical illness with limited life expectancy of less than 6 months
• • Pregnancy
• • Unable to obtain or refusal of informed consent from patient