Using non-selective beta-blockers (NSBBs) to prevent complications of liver cirrhosis.
Cirrhosis or liver scarring is a big problem in healthcare. In the United Kingdom, 60,000 people are living with cirrhosis. Sadly about 11,000 will die every year because of it.
Treating varices with beta blockers
Cirrhosis causes pressure changes inside the abdomen (tummy). This causes swelling of veins in the oesophagus (the tube that leads from the mouth to the stomach). These swollen veins are called “varices”. And they can be very dangerous if they bleed.
We already know that medicines called beta-blockers can be used to treat large varices. The beta blockers reduce the pressure in these varices, so they are less likely to bleed.
We do not yet know if beta-blockers can also help when varices are small. That’s why we’re doing this research.
The study is led by Dr Vishal Patel and Dr Mark McPhail from the Institute of Liver Sciences, King’s College Hospital. They are working with King’s College London Clinical Trials Unit. Dr Patel states:
This is a huge opportunity for a potentially landmark study, and if effective could benefit the lives of thousands of patients with cirrhosis in the UK. We are looking forward to working with our colleagues across the UK to successfully deliver this trial.
The BOPPP Trial
the BOPPP Trial (Beta Blockers or Placebo for Primary Prophylaxis of oesophageal varices) is a UK wide multi-centre study. It has received £2.5 million of funding from the National Institute for Health and Care Research (NIHR).
The study aims to find out whether taking a non-selective beta-blocker (NSBB) can reduce the complications experienced by people with cirrhosis and small varices.
740 participants across 55 hospitals in the UK will be given a beta-blocker (carvedilol) or a dummy drug (placebo). They will be followed up for up to three years.
The study will also look at how beta blocker treatment can be managed effectively by GPs. Dr Harry Ahmed, an academic GP at Cardiff University states:
I am delighted that this important trial is collaborating with primary care from the outset, to understand how NSBB can be safely titrated and managed in the community.
Patients are a vital part of clinical research and not just as trial participants. The British Liver Trust works to ensure that those with lived experience of a condition are involved in the design and running of research studies.
Peter is a cirrhosis patient and volunteers for the British Liver Trust to support research projects in this way. He agreed to provide patient involvement and be part of the governance team for the BOPPP trial.
“Cirrhosis has such a stigma.
When The British Liver Trust asked me if I would take part (in the BOPPP trial) I jumped at the opportunity for two reasons. Stigma I have already mentioned, the other is that in the 17 years I have had cirrhosis, new treatments have been slow in coming forward. I also noticed changes in the thinking. It used to be thought of as a condition where the patient would only deteriorate, now the thinking is that the liver can heal to an extent. Being involved in this proactive research was just what I was looking for.”
“I had to keep the British Liver Trust up to date on progress. Being a patient myself, I was to give the group insight into how people living with cirrhosis may feel about taking part in the research.”
“I was concerned I would not understand some of the medical terminology. But all those I met were very welcoming and went out of their way to put me at ease. If there was anything I did not understand I felt at ease asking for clarification. This also meant that they could take my input into account when producing patient facing information and ensure that it was understandable and not too technical. The whole team were amazing and I felt I was making a small contribution.”
Potential impact
The target of 740 participants was achieved and surpassed in July 2024. It is hoped that having so many people involved will enable this exciting research to produce valuable results. The study has been met with great support from liver specialists across the UK.
Dr McPhail, chief scientific investigator on the study, states:
“We predict a reduction in liver bleeding by almost 50% after three years of follow up with less hospital admissions”.
The study is due to run until the end of 2026. The researchers will compare the results from people taking the beta-blocker to those who were given the placebo. They will then publish the results in medical literature and share the findings at medical conferences. As well as working with participants and organisations including The British Liver Trust to share what they have found.
“I sincerely hope that the outcome is successful. An early treatment… will be a massive step forward. I also hope that it will encourage more research. “
-Peter
You can find out more about patient involvement in the BOPPP trial in this video.
BOPPP is a three-year study. Participants will have a follow up appointment a week after starting treatment. Then a phone call in week 6. They will then have follow up visits every 6 months.
You can find out more about the BOPPP trial from the trial website:
Website: www.boppp-trial.org
Email: kch-tr.boppptrial@nhs.net
BOPPP sites across the UK
BOPPP is the biggest liver trial in the UK working in 55 sites across England, Scotland, Wales and Northern Ireland.
| 1. Aberdeen Royal Infirmary – Grampian | 2. Derriford Hospital |
| 3. Addenbrooke’s Hospital | 4. East Surrey Hospital |
| 5. Aintree Hospital | 6. Freeman Hospital |
| 7. Basildon University Hospital | 8. Frimley Park Hospital |
| 9. Bedford Hospital NHS Trust | 10. Glasgow Royal Infirmary |
| 11. Bristol Royal Infirmary | 12. Gloucestershire Royal Hospital |
| 13. Broomfield Hospital | 14. Great Western Hospital |
| 15. Chelsea and Westminster Hospital | 16. Hull Royal Infirmary |
| 17. Kettering General Hospital | 18. Royal Derby Hospital |
| 19. King’s College Hospital | 20. Royal Devon and Exeter Hospital |
| 21. Kings Mill Hospital | 22. Royal Free Hospital |
| 23. Kingston Hospital | 24. Royal Liverpool University Hospital |
| 25. Leicester General Hospital | 26. Royal London Hospital |
| 27. Lewisham General Hospital | 28. Royal Surrey County Hospital |
| 29. Maidstone Hospital | 30. Royal Sussex County Hospital |
| 31. Medway NHS Foundation Trust | 32. Royal Victoria Hospital |
| 33. Ninewells Hospital – Tayside | 34. Southmead Hospital |
| 35. Pinderfields Hospital | 36. St Georges Hospital |
| 37. Princess Royal University Hospital | 38. St Marys Hospital |
| 39. Queen Alexandra Hospital | 40. St Thomas’ Hospital |
| 41. Queen Elizabeth Gateshead | 42. Sunderland Royal Hospital |
| 43. Queen Elizabeth Hospital | 44. The James Cook University Hospital |
| 45. Queen Elizabeth University Hospital | 46. Torbay Hospital |
| 47. Queens Medical Centre | 48. University Hospital Coventry |
| 49. Royal Berkshire Hospital | 50. University Hospital Of North Durham |
| 51. Royal Bolton Hospital | 52. University Hospital of Wales |
| 53. Royal Bournemouth Hospital | 54. Watford General Hospital |
| 55. Wythenshawe Hospital |
This study started in Jun 2019. It is funded by the National Institute of Health and Care Research: Health Technology Assessment (NIHR: HTA) programme. Dr Vishal Patel from King’s College Hospital is the Chief Investigator and Dr Mark McPhail from King’s College London is the Chief Scientific Investigator of the study. The trial number is ISRCTN10324656.
