RecruitingPhase 4NCT06449339

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

Baveno VII Criteria-guided Initiation of Non-selective Beta Blocker in Patients With Compensated Advanced Chronic Liver Disease to Reduce Hepatic Decompensation: an Open-label Randomised Controlled Trial

Sponsor

Chinese University of Hong Kong

Enrollment

474 participants

Start Date

Jul 17, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Chronic Liver Disease Portal Hypertension Hepatic Decompensation

Summary

The goal of this randomised controlled trial is to evaluate the effect of carvedilol (a non-selective beta-blocker) in patients with compensated advanced chronic liver disease under clinically significant portal hypertension or the grey zone of Baveno VII criteria. The main question it aims to answer is: Does carvedilol reduce hepatic decompensation and mortality in these patients despite the absence of varices needing treatment. Researchers will compare carvedilol to no carvedilol to see if carvedilol can prevent hepatic decompensation and mortality. Participants will either take carvedilol or not taking carvedilol for 5 years with regular clinic visit for checkups and investigations, including blood tests, ultrasonography of the liver, upper gastrointestinal endoscopy, transient elastography.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether giving non-selective beta-blockers (a type of heart/liver medication) to people with advanced but compensated (stable) chronic liver disease can prevent serious complications, before those complications arise. Eligible patients have certain liver scarring levels without active bleeding or major complications yet. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced chronic liver disease (from alcohol, hepatitis B, hepatitis C, or fatty liver disease) - You fall into a specific risk category based on liver stiffness measurements and other criteria **You may NOT be eligible if...** - You already have active liver-related complications (like variceal bleeding or ascites) - You have contraindications to beta-blockers (such as severe asthma) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarvedilol

Patients in the NSBB arm will receive generic carvedilol. The starting dose of oral carvedilol is 6.25mg daily (to be taken once or twice per day) and can be adjusted at each scheduled visit (either by increasing the dosage or frequency of dose administration) according to patients' tolerance, as well as the blood pressure and pulse rate that the systolic blood pressure should be not lower than 90 mmHg and pulse rate not lower than 55 beats per minute. The dosage of carvedilol can also be titrated or discontinued at unscheduled visit according to patient's condition. In case carvedilol is discontinued, it can be resumed from the starting dose at next scheduled visit if there is no contraindication for carvedilol. The dose of carvedilol will be kept at 6.25-12.5mg per day unless there are additional non-hepatic indications such as arterial hypertension or cardiac disease warranting higher carvedilol dosage. The maximum allowed dose of carvedilol is 50mg daily as per drug instruction.