NCT05872698Active, not recruitingPhase 4
Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial.
Beta-blockers Or Placebo for Primary Prophylaxis of Oesophageal Varices (BOPPP Trial). A Blinded, UK Multi-centre, Clinical Effectiveness and Cost-effectiveness Randomised Controlled Trial.
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
Research has proven that large varices can be treated with beta-blockers (a type of anti-hypertensive medication) to reduce the pressure in the veins. The management of small varices is still uncertain. This study aims to discover if beta blockers can be used in this setting. We hypothesize that beta blockers will reduce the risk of bleeding from small varices from 20% to 10% over a period of 3 years, resulting in significant cost savings to the NHS from better patient outcomes.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 763 (actual)
- First submitted
- 21 Jan 2021
- Start date
- 1 Apr 2019
- Primary completion date
- Dec 2026
- Lead sponsor
- King's College Hospital NHS Trust
- Diseases
- High blood pressure
- NCT number
- NCT05872698
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 763
- From 1 Apr 2019 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medium/large oesophageal varices (current or history \[decreasing in size without curative therapy\]), defined as \>5 mm in diameter
- Previous variceal haemorrhage
- Previous band ligation or glue injection of oesophageal and/or gastric varices
- Already receiving a beta-blocker for another reason that cannot be discontinued
- Graft cirrhosis post liver transplantation
- Patients who have been on a CTIMP within the previous 3 months
Other illness
- Non-cirrhotic portal hypertension
- Gastric (IGV and GOV2), duodenal, rectal varices with or without evidence of recent bleeding.
- Evidence of active malignancy without curative therapy planned
- Clinical symptoms consistent with COVID-19
Other
- 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
- Pregnant or lactating women
- Women of child bearing potential not willing to use adequate contraception during the period of IMP dosing, if relevant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.