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