Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors

Launched by CHINESE UNIVERSITY OF HONG KONG · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of stopping non-selective beta-blockers (NSBBs) in patients with cirrhosis, a serious liver condition. Researchers want to see if patients who have effectively managed their primary liver disease (like hepatitis or alcohol use) and have no varices (swollen blood vessels in the esophagus) can safely stop taking these medications. The study will include around 375 participants who are 18 years or older and have specific health criteria, such as having a liver stiffness measurement below 25 kPa and a history of varices.

Participants will stop taking NSBBs and will have follow-up examinations, including an endoscopy (a test to look inside the esophagus), one year later to check for any recurrence of varices. The goal is to ensure that less than 5% of participants experience a return of varices. Throughout the study, participants will also undergo various clinical assessments and tests to help understand any factors that might predict the return of varices. If the trial shows promising results, it may lead to further studies on complications related to varices in the coming years.

Gender

ALL

Eligibility 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)