Status:
UNKNOWN
Beta-blockers for Oesophageal Varices
Lead Sponsor:
King's College Hospital NHS Trust
Collaborating Sponsors:
King's College London
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Cirrhoses, Liver
Oesophageal Varices
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To determine if carvedilol reduces the rate of variceal haemorrhage in patients with cirrhosis and small oesophageal varices
Detailed Description
Cirrhosis or liver scarring is an important problem in healthcare in the United Kingdom. 60,000 patients are living with this disease and about 11,000 people every year will die because of it. There a...
Eligibility Criteria
Inclusion
- Age \>18 years
- 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
- 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
- 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
- Child Pugh C cirrhosis
- Already receiving a beta-blocker for another reason that cannot be discontinued
- Graft cirrhosis post liver transplantation
- Evidence of active malignancy without curative therapy planned
- Pregnant or lactating women
- Women of child bearing potential not willing to use adequate contraception during the protocol of IMP dosing
- Patients who have been on a CTIMP within the previous 3 months
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03776955
Start Date
June 17 2019
End Date
December 1 2024
Last Update
October 3 2019
Active Locations (4)
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1
Royal Victoria Hospital
Belfast, Northern Ireland, United Kingdom, BT12 6BA
2
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TT
3
Royal London Hospital (Barts)
London, United Kingdom, E1 1FR
4
King's College Hosptial NHS Foundation Trust (Denmark Hill)
London, United Kingdom