Checks whether stopping beta-blockers is safe in cirrhosis patients
Follows people with cirrhosis after stopping beta-blocker medicine, checking for varices again.
Plain-language title generated from the registry record
Registry title: Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors
Key facts
- Where
- Hyderabad and New Delhi, IndiaSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cirrhosis who take non-selective beta-blockers for varices or portal hypertension. Their liver cause must be under control, and their liver stiffness must be under 25 kPa.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Cirrhosis shown by scans or clinical signs. History of varices, variceal bleeding or portal hypertension that needed a beta-blocker. Liver stiffness (LSM) under 25 kPa.
- Earlier treatment
- The main cause of liver disease must be removed or controlled: sustained virological response in hepatitis C, complete hepatitis B virus DNA suppression in hepatitis B, or long-term alcohol abstinence in alcohol-related liver disease.
- Biomarker or test result
- Liver stiffness measurement (LSM) under 25 kPa.
Main reasons for not taking part
- Active liver disease cause not covered above, such as autoimmune or hereditary liver disease
- Worsening of liver function in the past year
- Current or past liver cancer (hepatocellular carcinoma)
- Blood clot in the portal vein on scans
- Past liver transplant or liver surgery (resection)
Read by machine on 12 November 2026.
Where in India
- Aig HospitalHyderabad, IndiaContact: Anand Kulkarni, MDNot yet recruiting
- Institute of Liver and Biliary SciencesNew Delhi, IndiaContact: Ashok Choudhury, MDNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Chinese University of Hong Kong
- Trial code
- NCT06549673
- Record updated
- 22 August 2025
- Original description
This multicentre, prospective cohort study aims to enrol 375 patients with cirrhosis who meet the following criteria:Read full original descriptionShow less
Assessing the Safety of Discontinuing Non-selective Beta-blockers in Cirrhotic Patients With Managed Primary Aetiological Factors According to Baveno VII Consensus
This multicentre, prospective cohort study aims to enrol 375 patients with cirrhosis who meet the following criteria:
1. effective management or elimination of the primary aetiological factor (i.e., sustained virological response in chronic hepatitis C, complete viral suppression in chronic hepatitis B, or long-term alcohol abstinence in alcohol-related liver disease), 2. liver stiffness measurements under 25 kPa, and 3. absence of varices as confirmed by endoscopy
Following the cessation of non-selective beta-blockers, patients will undergo a follow-up endoscopy at the one-year mark. The study's primary endpoint is recurrent varices in 1 year. Success will be defined as the upper bound of the 95% confidence interval for recurrent varices being <5%. Should this criterion be met, the study will extend to predefined analyses of variceal haemorrhage and hepatic decompensation at 3-and 10-year intervals (funded through local resources; the General Research Fund will cover patient recruitment costs for 1 year). Clinical assessments, laboratory tests, liver and spleen stiffness measurements will be performed at baseline, 3 months, 6 months and 12 months to identify potential predictors of variceal recurrence and assess the feasibility of early identification.
Inclusion: 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: 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; Current or history of hepatocellular carcinoma; Radiological evidence of portal vein thrombosis; History of liver transplantation or liver resection; Other clinical indications for NSBB (e.g., cardiovascular disease, arterial hypertension); 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; History of other malignancies (unless in complete remission for >5 years); Contraindications to undergoing endoscopy.