Beta-blockers for Oesophageal Varices (NCT03776955) | Clinical Trial Compass
UnknownPhase 4
Beta-blockers for Oesophageal Varices
United Kingdom1,200 participantsStarted 2019-06-17
Plain-language summary
To determine if carvedilol reduces the rate of variceal haemorrhage in patients with cirrhosis and small oesophageal varices
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \>18 years
. Cirrhosis and portal hypertension, defined by any 2 of the following:
. Small oesophageal varices diagnosed within the last 3 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
Exclusion criteria
. Non-cirrhotic portal hypertension
. Medium/large oesophageal varices (current or history of), defined as \>5 mm in diameter
. Isolated gastric, duodenal, rectal varices with or without evidence of recent bleeding
. Previous variceal haemorrhage
. Red signs accompanying varices at endoscopy
. Known intolerance to beta blockers
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Contraindication to beta blocker use i) Heart rate \<50 bpm ii) Known 2nd degree or higher heart block iii) Sick sinus syndrome iv) Systolic blood pressure \<85 mm Hg v) Chronic airways obstruction (asthma/COPD) vi) Floppy Iris Syndrome vii) CYP2D6 Poor Metaboliser viii) History of cardiogenic shock ix) History of severe hypersensitivity reaction to beta-blockers x) Untreated phaeochromocytoma xi) Severe peripheral vascular disease xii) Prinzmetal angina xiii) New York Heart Association IV heart failure