Overview

Beta-blockers for Oesophageal Varices

Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
0
Participant gender:
All
Summary
To determine if carvedilol reduces the rate of variceal haemorrhage in patients with cirrhosis and small oesophageal varices
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
King's College Hospital NHS Trust
Collaborators:
Brighton and Sussex University Hospitals NHS Trust
Cardiff University
Guy's and St Thomas' NHS Foundation Trust
King's College London
St George's University Hospitals NHS Foundation Trust
Treatments:
Adrenergic beta-Antagonists
Carvedilol
Criteria
Inclusion Criteria:

1. Age >18 years

2. Cirrhosis and portal hypertension, defined by any 2 of the following:

A) Characteristic clinical examination findings; one or more of i) liver function
tests ii) haematological panel iii) coagulation profile abnormalities B)
Characteristic radiological findings; one or more of i) heterogeneous, small liver
with irregular contour ii) splenomegaly iii) ascites iv) varices v) recanalized
umbilical vein C) Fibrosis score > stage 4 on liver biopsy D) FibroScan liver
stiffness measurement >15 kilo Pascal without other explanation

3. 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.

4. Not received a beta-blocker in the last week

5. Capacity to provide informed consent

Exclusion Criteria:

1. Non-cirrhotic portal hypertension

2. Medium/large oesophageal varices (current or history of), defined as >5 mm in diameter

3. Isolated gastric, duodenal, rectal varices with or without evidence of recent bleeding

4. Previous variceal haemorrhage

5. Red signs accompanying varices at endoscopy

6. Known intolerance to beta blockers

7. 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

8. Unable to provide informed consent

9. Child Pugh C cirrhosis

10. Already receiving a beta-blocker for another reason that cannot be discontinued

11. Graft cirrhosis post liver transplantation

12. Evidence of active malignancy without curative therapy planned

13. Pregnant or lactating women

14. Women of child bearing potential not willing to use adequate contraception during the
protocol of IMP dosing

15. Patients who have been on a CTIMP within the previous 3 months