Using carvedilol to prevent liver complications in patients with advanced chronic liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial evaluates the effectiveness of carvedilol, a non-selective beta-blocker, in patients with compensated advanced chronic liver disease who have clinically significant portal hypertension. Participants will be assigned to either receive carvedilol or not for a duration of five years, with regular follow-ups including blood tests and liver imaging. The study aims to determine if carvedilol can reduce the risk of hepatic decompensation and mortality in patients without high-risk varices. Conducted at multiple centers, including the Prince of Wales Hospital in Hong Kong, the trial will follow patients for a total of five years to assess outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Prince of Wales Hospital, The Chinese University of Hong Kong
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Jimmy Che-To Lai, MB ChB — Chinese University of Hong Kong
• Study coordinator: Angel Chim, MSc
• Email: angelchim@cuhk.edu.hk
• Phone: +852 3505 4205

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• 4D-Flow MRI to see portal hypertension and TIPS outcomes in cirrhosis

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• Apixaban plus carvedilol to prevent portal-hypertension complications in cirrhosis

  This will test whether adding apixaban to carvedilol can help prevent variceal bleeding, portal vein thrombosis, and other portal-hypertension complications in adults with Child-Pugh B cirrhosis.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.