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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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
King's College Hospital
RECRUITING
London
Contact Information
Primary
Ruhama Uddin
kch-tr.boppptrial@nhs.net
0203 299 7142
Backup
Vishal Patel
vishal.patel@nhs.net
Time Frame
Start Date: 2019-06-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 1200
Treatments
Active_comparator: Carvedilol
Oral Carvedilol 6.25 mg to 12.5 mg OD/ or 6.25mg BD (maximum dose 12.5mg)
Placebo_comparator: Placebo
Oral tablet (1 or 2 tablets)
Sponsors
Leads: King's College Hospital NHS Trust
Collaborators: Brighton and Sussex University Hospitals NHS Trust, Cardiff University, King's College London

This content was sourced from clinicaltrials.gov