Cirrhoses, Liver Clinical Trial
— BOPPPOfficial title:
Beta-blockers or Placebo for Primary Prophylaxis of Oesophageal Varices (BOPPP Trial). A Blinded, Multi-centre, Clinical Effectiveness and Cost-effectiveness Randomised Controlled Trial
NCT number | NCT03776955 |
Other study ID # | 125861 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 17, 2019 |
Est. completion date | December 2024 |
To determine if carvedilol reduces the rate of variceal haemorrhage in patients with cirrhosis and small oesophageal varices
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Victoria Hospital | Belfast | Northern Ireland |
United Kingdom | Queen Elizabeth Hospital | Birmingham | |
United Kingdom | King's College Hosptial NHS Foundation Trust (Denmark Hill) | London | |
United Kingdom | Royal London Hospital (Barts) | London |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust | 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 |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variceal bleeding | Time to first variceal haemorrhage | 3 years | |
Primary | Health Economic assessment | Assess the cost effectiveness of early intervention with non specific beta blockers in this patient population. | 3 years | |
Secondary | Variceal bleed rate | Number of variceal bleeds by allocation | 1 and 3 years | |
Secondary | Variceal bleeding needing intervention | Number of patients that progress to medium/large varices requiring clinical intervention | 3 years | |
Secondary | Composite of variceal bleed rate and bleeding needing intervention | Composite of variceal bleed rate and bleeding needing intervention. i.e. Unit less measure of rate of ((Number of patients who bled) PLUS (Number of patients who progressed without bleeding)) / (Number of patients in that arm at randomisation) at 3 years ranging from 0 to 1 | 3 years | |
Secondary | Clinical decompensation | Number of patients with clinical decompensation (spontaneous bacterial peritonitis, new ascites, new hepatic encephalopathy) in the active and inactive IMP groups | 3 years | |
Secondary | Child Pugh Score for Cirrhosis mortality | Child Pugh Score for Cirrhosis mortalityin the active and inactive IMP groups. Range 5-15. Higher scores represent worse outcomes. | 3 years | |
Secondary | Model for end-stage liver disease (MELD) score | MELD score in the active and inactive IMP groups.Range 6-40. Higher scores represent worse outcomes. | 3 years | |
Secondary | Survival (Overall, liver related, cardio-vascular related) | Survival (Overall, liver related, cardio-vascular related) | 3 years | |
Secondary | Quality of life assessment | Quality of life score using EQ5D-5L in the active and inactive IMP groups. Range 5-25. Higher scores represent worse outcomes. | 3 years |
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---|---|---|---|
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