Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06449339

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

Led by Chinese University of Hong Kong · Updated on 2025-06-22

474

Participants Needed

1

Research Sites

367 weeks

Total Duration

On this page

Sponsors

C

Chinese University of Hong Kong

Lead Sponsor

S

Singapore General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Established diagnosis of chronic liver disease from alcohol-related liver disease, chronic hepatitis B, chronic hepatitis C, or metabolic dysfunction-associated steatotic liver disease (both non-obese and obese)
  • Classified in high-risk grey zone or with clinically significant portal hypertension based on Baveno VII criteria or ANTICIPATE-NASH model within 6 months before screening
  • Underwent liver stiffness measurement (LSM) and platelet count assessment to determine eligibility
Not Eligible

You will not qualify if you...

  • Presence of high-risk varices such as moderate to large oesophageal varices or varices with red wale sign
  • Current or recent use (within 6 months) of non-selective beta-blockers
  • Contraindication to non-selective beta-blockers including heart block, bradycardia, low systolic blood pressure, asthma, poorly controlled chronic obstructive pulmonary disease, or peripheral vascular disease
  • Current or recent use (within 6 months) of nitrated drugs except sublingual nitrates
  • Contraindication to upper gastrointestinal endoscopy
  • Current or history of decompensated liver cirrhosis or prior decompensation events
  • Current or history of hepatocellular carcinoma
  • Current or history of portal vein thrombosis
  • Presence of transjugular intrahepatic portosystemic shunt (TIPS)
  • Prior liver transplantation
  • Serious medical illness with life expectancy less than 6 months
  • Pregnancy
  • Unable or unwilling to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

A

Angel Chim, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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