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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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
✕. 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
✕. Unable to provide informed consent

Variceal bleeding

Timeframe: 3 years

Health Economic assessment

Timeframe: 3 years

NCT IDNCT03776955

SponsorKing's College Hospital NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09

Vishal Patel, BSc, MBBS, MRCP, MPhil

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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
✕. 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
✕. Unable to provide informed consent