Patient Information

Why are we doing this study?

We are doing this research because we want to improve the treatment of patients with ischaemic heart disease (IHD). The study will investigate whether adding allopurinol, up to 600mg daily, to the medication of patients with IHD will reduce their risk of having a stroke, heart attack or of dying due to cardiovascular disease.

What is ischaemic heart disease (IHD)?

IHD is a common problem in the UK, involving narrowing or partial blockage of the blood vessels to the heart. It can result in chest pain (angina) or even heart attack (myocardial infarction).

What is allopurinol?

Allopurinol is the drug that we are testing in this study. It is licensed in the UK for the prevention of gout. It is not currently licensed for use to treat IHD, although many patients with IHD will have taken it for gout.

Are there any side-effects of allopurinol?

Allopurinol is a well established and widely prescribed drug, but like all drugs it has a number of potential side-effects, including skin rash (this can occasionally be serious), allergic reactions, nausea, vomiting, drowsiness and diarrhoea.

How many patients will be involved?

5,215 patients across Scotland and England will be involved in the study.

Who can take part?

Recruitment for new patients is now closed.

You might be able to take part if you.

What will happen to me if I take part?

If you are interested in taking part in the ALL-HEART study, we will arrange an appointment with a nurse, usually at your own GP practice. This appointment should take around one hour. The nurse will discuss the study with you and answer any questions you may have. If you decide that you would like to take part, you will be asked to sign a consent form.

The nurse will then ask you some questions about your medical history, current health and the medicines you take. You will have your blood pressure, pulse rate, weight and height measured and we will take a blood sample (around 10ml in total) to check your health. You will be asked to complete two short questionnaires about your condition and how it affects your quality of life. The nurse will also review your medical records to check that you are eligible to take part in the study and that it is likely to be safe for you to do so. At this stage, you will be randomised either to take your usual medication, or to take your usual medication along with allopurinol.

This decision will be made randomly so that we can see which course of treatment is best for patients with IHD. If you are randomised to allopurinol, your GP will prescribe it along with your usual medication. If you are randomised not to receive allopurinol, there will be no change to your medication.

Every year, we will send you short questionnaires about your health and quality of life. These will help us to find out if allopurinol helps patients with IHD.

Do I have to take part?

Taking part in medical research in the UK is entirely voluntary and you should feel under no pressure to take part if you do not think it is right for you.

If you are interested in finding out more about the study, please ask your GP about the ALL-HEART study, or get in touch with a member of the study team using the contact details on the back page of this leaflet.

What are the possible benefits of taking part?

Until we complete this study, we do not know whether allopurinol will have benefits for patients with IHD. Taking part in the ALL-HEART study may not result in any benefit to you personally but the information we get may improve the treatment of people with IHD in the future.

How will this study help?

The results of this study could have major benefits for patients and result in significant cost savings for the NHS if allopurinol is found to be effective, as it would be inexpensive and easy to introduce quickly to patient care within the UK.

Who is running this study?

The ALL-HEART study is being run by the University of Dundee and NHS Tayside, working closely with the University of Nottingham and other University and NHS centres across Scotland and England.

The team running this study has a lot of experience in running large clinical studies of this type, and already works with more than 700 general practices.

Who is funding this study?

This study is funded by the National Institute for Health Research, Health Technology Assessment Program The study is supported by the Scottish Primary Care Research Network (SPCRN) and the Primary Care Research Networks and Comprehensive Local Research Networks in England.

What are the alternatives for treatment?

If you do not want to take part in the ALL-HEART study, your GP will continue to give you the usual care for patients with IHD.

Will my taking part in the study be kept confidential?

Yes, your personal details and information we record will be kept strictly confidential. You will not be identified in any future publications or reports related to this study. We will ask your permission to tell your GP that you are taking part in this study.

What will happen to any blood sample I give?

The blood samples will be tested by a local NHS laboratory, to make sure it is safe for you to take part in the study. The results will be sent back to your GP and checked by the study nurse. After the samples have been tested, they will be destroyed, usually within a few days. No samples will be stored for future use.

What will happen to the results of the study?

The results of the study will be published in medical journals and will help doctors and the NHS to decide if allopurinol is beneficial for the treatment of patients with IHD. You will be informed of the study results when they are available.

How can I withdraw from the study?

If you are already taking part but would like to withdraw your consent from the ALL-HEART study, please contact the ALL-HEART study team on 0800 7310243 or 01382 383119. You can also withdraw your consent by writing to us at The ALL-HEART study, Medicines Monitoring Unit (MEMO), Mailbox 2, Level 7, Ninewells Hospital and Medical School, Dundee, UK, DD1 9SY or by sending an email to .

Record Linkage Update - May 2017

We have added additional details about how patients’ data is handled during the course of the study. Please click here to view details.

Update on study recruitment – December 2017

We are pleased to report that recruitment to the ALL-HEART study is complete and the study is now continuing in the ‘follow-up’ stage for several more months. The number of participants we had originally planned to include in the study was 5215. However, due to a sudden and unexpected increase in the number of people choosing to take part in the study in summer 2017, the final number of patients in the study is 5938. Every participant is making an invaluable contribution to this research and will help us to answer the question of whether allopurinol improves cardiovascular outcomes in people with ischaemic heart disease. We remind participants that they are free to withdraw from the study at any time by contacting the study team on 01382 383119 or freephone 0800 7310243 or by emailing us at . We would like to thank all patients for their continuing participation.