RecruitingPhase 4NCT05872698

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.

Sponsor

King's College Hospital NHS Trust

Enrollment

1,200 participants

Start Date

Jun 1, 2019

Study Type

INTERVENTIONAL

Conditions

Cirrhosis, Liver Portal Hypertension Variceal Hemorrhage Varices, Esophageal

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a common blood pressure medication called a beta-blocker can prevent small oesophageal varices (enlarged, fragile veins in the food pipe caused by liver disease) from growing larger and potentially bleeding — a dangerous complication of cirrhosis. **You may be eligible if...** - You are 18 or older - You have cirrhosis (liver scarring) with portal hypertension (high pressure in the veins around the liver) - You have been found to have small oesophageal varices (≤5 mm) within the last 6 months on a scope examination - You have not taken a beta-blocker in the past week - You are able to give informed consent **You may NOT be eligible if...** - Your oesophageal varices are medium or large - You have portal hypertension without cirrhosis - You have certain conditions where beta-blockers are unsafe (e.g., severe asthma, very slow heart rate) - You have already had a variceal bleed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarvedilol

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.

DRUGPlacebo

Placebo