RecruitingPhase 4

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

Hong Kong474 participantsStarted 2024-07-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 baseli…

What they're measuring

composite of incident high-risk varices (HRV), hepatic decompensation or death

Timeframe: 5 years

Trial details

NCT IDNCT06449339

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-07-30

Contact for this trial

Angel Chim, MSc

+852 3505 4205 angelchim@cuhk.edu.hk