Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial. (BOPPP)
Cirrhosis, Liver, Portal Hypertension, Variceal Hemorrhage
About this trial
This is an interventional prevention trial for Cirrhosis, Liver
Eligibility Criteria
Inclusion Criteria: Age 18 years and over Cirrhosis and portal hypertension, Small oesophageal varices diagnosed within the last 6 months, defined as ≤5 mm in diameter or varices which completely disappear on moderate insufflation at gastroscopy. Not received a beta-blocker in the last week Capacity to provide informed consent Exclusion Criteria: Non-cirrhotic portal hypertension Medium/large oesophageal varices (current or history [decreasing in size without curative therapy]), defined as >5 mm in diameter Gastric (IGV and GOV2), duodenal, rectal varices with or without evidence of recent bleeding. Previous variceal haemorrhage Previous band ligation or glue injection of oesophageal and/or gastric varices Red signs accompanying varices at endoscopy Known intolerance to beta blockers Contraindications to beta blocker use Unable to provide informed consent Child Pugh C cirrhosis Already receiving a beta-blocker for another reason that cannot be discontinued Graft cirrhosis post liver transplantation Evidence of active malignancy without curative therapy planned Pregnant or lactating women Women of child bearing potential not willing to use adequate contraception during the period of IMP dosing Patients who have been on a CTIMP within the previous 3 months Clinical symptoms consistent with COVID-19
Sites / Locations
- King's College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Carvedilol
Placebo
Oral Carvedilol 6.25 mg to 12.5 mg OD/ or 6.25mg BD (maximum dose 12.5mg)
Oral tablet (1 or 2 tablets)