Stopping non-selective beta-blockers in people with cirrhosis whose main cause is controlled
Assessing the Safety of Discontinuing Non-selective Beta-blockers in Cirrhotic Patients With Managed Primary Aetiological Factors According to Baveno VII Consensus
This study will try stopping non-selective beta-blockers in adults with cirrhosis who have their primary liver disease controlled, low liver stiffness, and no varices to see if varices come back within one year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 375 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 8 sites (Sydney and 7 other locations) |
| Trial ID | NCT06549673 on ClinicalTrials.gov |
What this trial studies
This is a multicentre prospective cohort enrolling about 375 patients with cirrhosis who have effective control or elimination of the primary cause (for example, cured hepatitis C, suppressed hepatitis B, or long-term alcohol abstinence), liver stiffness below 25 kPa, and no varices on endoscopy. Enrolled patients will stop non-selective beta-blockers and undergo a follow-up endoscopy at one year to detect recurrent varices. The primary endpoint is recurrent varices at one year with success defined as the upper bound of the 95% confidence interval for recurrence being less than 5%. If that threshold is met, predefined analyses of variceal bleeding and hepatic decompensation at 3 and 10 years will be pursued using local funding.
Who should consider this trial
Good fit: Adults with established cirrhosis who previously required NSBBs, who have had their primary aetiological factor controlled (e.g., sustained virologic response for HCV, HBV suppression, or long-term alcohol abstinence), have liver stiffness under 25 kPa, and have no varices on endoscopy are ideal candidates.
Not a fit: Patients with ongoing active liver disease, recent hepatic decompensation, high liver stiffness, existing varices, or uncontrolled aetiologies are unlikely to benefit from stopping NSBBs in this protocol.
Why it matters
Potential benefit: If successful, patients who no longer need beta-blockers could avoid medication side effects and reduce long-term treatment burden while maintaining a low risk of variceal recurrence.
How similar studies have performed: Smaller retrospective and single-centre series have suggested stopping NSBBs can be safe in carefully selected patients, but prospective multicentre evidence has been limited until now.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or above * Evidence of cirrhosis, based on either radiological and/or clinical features * History of varices, variceal haemorrhage or portal hypertension warranting NSBB * Removal or suppression of the primary aetiological factor (i.e., sustained virological response in chronic hepatitis C, complete hepatitis B virus DNA suppression in chronic hepatitis B, and long-term alcohol abstinence in alcohol-related liver disease) * LSM \<25 kPa * Provision of written informed consent Exclusion Criteria: * Active aetiological factors not addressed in the inclusion criteria (e.g., autoimmune or hereditary liver diseases). However, hepatic steatosis-commonly coexisting with other liver diseases-is not an exclusion criterion unless accompanied by high plasma alanine aminotransferase \>40 U/L or confirmed steatohepatitis. * Recent hepatic decompensation within the past year (total bilirubin \>50 μmol/L, prothrombin time \>1.3 times the upper normal limit \[unless attributable to use of anti-coagulation\], albumin \<35 g/L, or presence of ascites, variceal haemorrhage or hepatic encephalopathy). Notably, the Baveno VI criteria used LSM \<20-25 kPa and normal platelet count \>150×109/L to rule out varices requiring treatment (19). However, in line with the Baveno VII consensus, which sets an LSM \<25 kPa as the threshold for considering NSBB discontinuation, thrombocytopenia is not an exclusion criterion to allow the cohort to include a wider spectrum of patients. * Current or history of hepatocellular carcinoma. * Radiological evidence of portal vein thrombosis. * History of other malignancies (unless in complete remission for \>5 years). * History of liver transplantation or liver resection. * Contraindications to undergoing endoscopy. * Other clinical indications for NSBB (e.g., cardiovascular disease, arterial hypertension)
Where this trial is running
Sydney and 7 other locations
- Royal Prince Alfred Hospital — Sydney, Australia (Not_yet_recruiting)
- Southern Medical University — Guangzhou, China (Not_yet_recruiting)
- Ruijing Hospital — Shanghai, China (Not_yet_recruiting)
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
- AIG Hospital — Hyderabad, India (Not_yet_recruiting)
- Institute of Liver and Biliary Sciences — New Delhi, India (Not_yet_recruiting)
- Changi General Hospital — Singapore, Singapore (Not_yet_recruiting)
- National University Hospital, Singapore — Singapore, Singapore (Not_yet_recruiting)
Study contacts
- Principal investigator: Vincent Wong, MD — Chinese University of Hong Kong
- Study coordinator: Vincent Wong, MD
- Email: wongv@cuhk.edu.hk
- Phone: 85235051299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.