Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial.

NCT05872698 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 255446
• Study Type: interventional
• Target: 763
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time to All-Cause Decompensation

  All-cause decompensation is defined as the occurrence of any of the below: Liver-related mortality Variceal haemorrhage Spontaneous bacterial peritonitis Hepatorenal syndrome New or worsening hepatic encephalopathy New or worsening ascites Sustained increase in Child Pugh Grade by 1 grade or MELD by 5 points

  up to 3 years from recruitment

Study Arms (2)

Carvedilol

ACTIVE COMPARATOR

Oral Carvedilol 6.25 mg to 12.5 mg OD/ or 6.25mg BD (maximum dose 12.5mg)

Drug: Carvedilol

Placebo

PLACEBO COMPARATOR

Oral tablet (1 or 2 tablets)

Drug: Placebo

Interventions

Carvedilol DRUG

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.

Carvedilol

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, if relevant

Sponsors & Collaborators

• Cardiff University: collaborator
• Brighton and Sussex University Hospitals NHS Trust: collaborator
• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital

London, London, SE5 9RS, United Kingdom

Location

Related Links

• Using a theory-informed approach to explore patient and staff perspectives on factors that influence clinical trial recruitment for patients with cirrhosis and small oesophageal varices
• General practitioner perspectives on factors that influence implementation of secondary care-initiated treatment in primary care: Exploring implementation beyond the context of a clinical trial

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Esophageal and Gastric Varices

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Mark McPhail

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: May 24, 2023
• Study Start: April 1, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)