Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial.
NCT05872698 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 763
Last updated 2026-05-01
Summary
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.
Conditions
- Cirrhosis, Liver
- Portal Hypertension
- Variceal Hemorrhage
- Varices, Esophageal
Interventions
- DRUG
-
Carvedilol
Carvedilol, sold under the brand name Coreg among others, is a medication used to treat high blood pressure, congestive heart failure, and left ventricular dysfunction in people who are otherwise stable. For high blood pressure, it is generally a second-line treatment. It is taken by mouth.
- DRUG
-
Placebo
Sponsors & Collaborators
- collaborator OTHER
-
Cardiff University
collaborator OTHER -
Brighton and Sussex University Hospitals NHS Trust
collaborator OTHER -
King's College Hospital NHS Trust
lead OTHER
Principal Investigators
-
Mark McPhail · King's College Hospital NHS Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-01
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- United Kingdom
Study Locations
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