Drug & Side Effects
In all situations, where you are concerned with side effects from the medication you are taking for BOPPP, please contact your BOPPP research nurse at the Hospital that is treating your liver disease. The contact number is in the Participant Information Sheet that was given to you when you were approached to participate.
Below are some symptoms and advice that may be associated to the BOPPP medication:
Chest pain – If you have any chest pain that is ongoing at rest – please go to your local Emergency Department. If you are experiencing chest pain that is intermittent – please go to your GP.
Fainting or collapse – If you have fainted or collapsed more than once – please go to your local Emergency Department. If you have fainted or collapsed once – please go to your GP.
Abnormal heart beats – If you have noticed that your heart is beating abnormally slow or fast – please go to your GP.
Rash – If you have noticed any rash on your skin that is new – please go to your GP.
Erectile dysfunction – If you have had any issues or problems with erections during intercourse – please go to your GP.
If you have lost your BOPPP medication, please immediately call your research nurse. Their phone number will be in the Participant Information Sheet that was given to you at the start of the trial.
Once you have spoken to the research nurse, you may have to visit the hospital again to collect your medication. If you are not able to visit the hospital, your BOPPP medication may be posted to you.
If you temporarily forget to take the BOPPP medication, pick up where you left off by taking your medication as scheduled. Never try to make up for missing doses.
At each visit to hospital, the research nurse will ask you how often you took your BOPPP medication. Please make sure you let the research nurse know at that time.
BOPPP is designed for patients with liver cirrhosis and small oesophageal varices. If you have liver cirrhosis and small oesophageal varices there is a Participant Information sheet that can be viewed here.
After reading this information sheet, if you are still interested in taking part, you will need to speak with the clinician dealing with your liver disease at the Hospital you are being treated at. To find out if the Hospital in charge of your liver disease is recruiting patients for BOPPP, please click here.
Sometimes we do not know which treatment is best. To find out, we compare different treatments by putting patients into groups with each receiving a different treatment. This would apply to anybody taking part in BOPPP. However, by taking part, you will be closely monitored for the duration of the trial and will be in regular contact with a Liver Unit Research Nurse.
At the end of the study, we will provide every patient a non-technical summary of the trial results. This document will show if early treatment with beta-blockers reduces the risk of bleeding in patients with liver cirrhosis and small oesophageal varices. This will allow you, your Liver Consultant and General Practitioner make an informed decision about your best long term treatment option.
It is very important that your GP knows about your participation in BOPPP. This is because there may be developments in your health where your GP needs to know what medications you are taking to avoid unnecessary drug interactions that might make you feel worse.
After you are given your BOPPP medication, the Research Nurse at the Hospital treating your liver disease will write to your GP, telling them that you are in the BOPPP trial. The GP will be provided with a copy of the Participant Information Sheet that you read before you decided to take part.
Your GP may be contacted by the Hospital treating your liver disease if you experience any adverse event out side of hospital to obtain relevant information to make sure that the severity of the event and relationship to the BOPPP medication is assessed accordingly.
Sometimes we do not know which treatment is best to give patients. To find out, we compare different treatments by putting patients into groups with each group receiving a different treatment. To ensure the groups are the same to start with, each patient is put into a group by chance i.e. randomly, selected using a computer that has no personal information about you.
One group is called the ‘active’ group and will receive Carvedilol and the other group, called the ‘control’ group, will receive a placebo treatment. There is a one in two chance of being allocated to either treatment (like flipping a coin).
The placebo treatment is a blank (or dummy) treatment and is made to resemble a Carvedilol tablet. Placebo does not contain any active drug. Using a placebo is called a ‘placebo controlled trial’ and ensures that the trial results are reliable by checking that any effects are actually due to the active drug and not influenced by you or your doctor from what we ‘expect’ to happen.
Neither you nor the research team nor the medical team will know which treatment you are receiving so this does not influence the trial results. This is called ‘blinding’. However, should we need to know what treatment you are on, there are mechanisms in place to ‘unblind’ if necessary.
All participants will be followed up at regular 6 month intervals and will have various routine tests. All of the tests in BOPPP are standard as part of your normal medical care when you have liver disease (cirrhosis).
There are two research specific questionnaires that we ask participants to complete: 1) a Quality of Life questionnaire and 2) a Healthcare Use questionnaire.
Trial treatment will be started at a small dose and increased after one week if required. You will be supported by a research nurse through your participation in the trial. This will not include conventional clinical care.
We ask all participants to take the study medication (beta-blocker of placebo) for 3 years in total. This does not stop you from withdrawing at any time and for any reason – without affecting your clinical care at your Hospital.
You will be asked to take one or two tablets every day. Neither you nor the research team nor the medical team will know which treatment you are receiving so this does not influence the trial results. This is called ‘blinding’. However, should we need to know what treatment you are on, there are mechanisms in place to ‘unblind’ if necessary.
Every 6 months, you will be seen at your hospital by your usual Consultant team as part of routine clinical care and have the usual range of tests that you would have normally. There are no extra research tests in this trial. During the same visit, you will also be seen by a Research Nurse who will ask you to complete 2 research questionnaires. Your study medication will be given to you at this visit.
Firstly, ascertain what the participant wants to withdraw from as this may refer to not completing the participant questionnaires, not taking the BOPPP medication and/or withdrawing permission from allowing us to analyse the participants Health Episode Statistics (HES) data.
Secondly, contact firstname.lastname@example.org to inform the central trial team so this can be documented and discussed with the BOPPP Statistician. In the case of withdrawing from BOPPP medication, please ask the participant if we can still collect data about their health and ascertain why the participant would like to withdraw. Record the discussion in patients medical notes and email
email@example.com, completing the relevant pages on MACRO.
Some travel insurance companies will ask you if for you are taking part in a clinical trial. This may affect your travel insurance insurance premiums with some companies, so you will need to do some research for companies will allow you to take part without affecting your premiums.
If you know of any travel insurance companies that are not influenced by patients taking part in clinical trials please email firstname.lastname@example.org so we can include that information on this website.