ALL-HEART
Research type
Research Study
Full title
Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (ALL-HEART)
IRAS ID
135900
Contact name
Isla Mackenzie
Contact email
Sponsor organisation
University of Dundee
Eudract number
2013-003559-39
ISRCTN Number
ISRCTN32017426
Research summary
Research Summary
The study team would like to thank all participants and collaborators.
Who carried out the ALL-HEART study?
The chief investigator of the ALL-HEART study was Professor Isla Mackenzie, Professor of Cardiovascular Medicine, University of Dundee. The study was jointly sponsored by the University of Dundee and NHS Tayside and was funded by the National Institute for Health and Care Research Health Technology Assessment programme NIHR HTA (HTA 11/36/41). The study was a collaboration between the University of Dundee, University of Glasgow, University of Nottingham, University College London, several NHS organisations and primary care practices and was supported by NIHR networks, the Scottish Primary Care Research Network and Support for Science Scotland.
What public involvement was there in the ALL-HEART study?
There was patient and public involvement from the design stage until the dissemination of results stage of the study, including two lay/patient members of the trial steering committee throughout the trial. Patient and lay contributors had direct or indirect lived experience of cardiovascular disease.
When and where did the ALL-HEART study take place?
The study started recruiting participants in 2014 and ended in 2022. Patients from 424 primary care practices in Scotland and England took part in the study at their local primary care practices and with remote follow-up.
Why was the research needed?
The ALL-HEART study was the first, large prospective randomised trial of allopurinol therapy versus usual care in patients with ischaemic heart disease internationally.
What were the main questions studied?
The aim of the ALL-HEART study was to determine whether adding allopurinol (a widely used gout medication) to the usual care of patients with ischaemic heart disease would reduce the incidence of strokes, heart attacks, or deaths due to cardiovascular disease. It also aimed to determine whether allopurinol therapy could improve other cardiovascular outcomes and quality of life in patients with ischaemic heart disease. A health economic analysis of using allopurinol for this purpose in the UK health system was also performed.Who participated in the study?
More than 5,000 patients aged over 60 years with ischaemic heart disease but no history of gout took part in the study.What treatments or interventions did the participants take/receive?
Participants were randomly allocated to take allopurinol up to 600mg daily in addition to their usual care or to continue their usual care. They were then followed up long term for the occurrence of any cardiovascular events such as myocardial infarction (heart attack), stroke or cardiovascular death. Details of other major health events such as other deaths, admission to hospital with heart failure and new cancers were also collected.What medical problems (adverse reactions) did the participants have?
Some of the participants had to stop taking allopurinol due to non-serious adverse reactions such as skin rash or gastrointestinal disturbance. Serious adverse events were similar between the group taking allopurinol and the group having usual care.What happened during the study?
Participants were seen by a nurse at their local primary care practice. Informed consent was taken, participants were screened for suitability to take part in the study, blood samples and baseline measurements were taken, then they were randomly allocated to be in the allopurinol group or the usual care group. Participants taking allopurinol were seen once more in six weeks to have further blood samples taken. After that, follow-up for both groups of participants was remote, by annual email, telephone or mail contact. Questionnaires were completed about whether participants had remained on their randomised treatment, any adverse events, any skin rashes or gout flares, health resource usage and quality of life measures. We also collected information on any hospitalisations, deaths or new cancers in participants from national databases in England (NHS Digital) and Scotland (Public Health Scotland). Participant follow-up continued until 30th September 2021 and the study formally ended on 31st March 2022. At the end of the study, we compared and analysed the information collected throughout the trial in the two groups of patients (allopurinol group and usual care group) to see if there was any improvement in health outcomes or quality of life in those patients in the allopurinol group.Summary of Results
What were the results of the study?
The results of the ALL-HEART study have shown no difference in the risk of heart attack, stroke or cardiovascular death between the two groups of patients. There was also no difference between the two groups in other important cardiovascular events, new cancers, deaths from any cause or quality of life outcomes.How has this study helped patients and researchers?
While we are disappointed that we did not find any benefit of allopurinol for patients with ischaemic heart disease, the ALL-HEART study has definitively answered an important question that has been around for many years in doctors’ minds about whether allopurinol might help people with ischaemic heart disease. The results will help doctors, nurses and pharmacists to make the right decisions regarding treatment of patients. They will also inform future research to improve treatment of heart disease. Allopurinol remains an important medication for the treatment of patients with gout. However, the ALL-HEART study results suggest that allopurinol should not be recommended for the secondary prevention of cardiovascular events in patients aged over 60 years with ischaemic heart disease but no gout.
Where can I learn more about this study?
The main study results were published in The Lancet in October 2022. The Lancet article can be accessed at https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01657-9/fulltextThe results of the health economic analysis will be published separately in a NIHR Journals report.
If you would like to contact us regarding the ALL-HEART study please email us at allheartstudy@dundee.ac.uk or contact the Chief Investigator, Professor Isla Mackenzie, Professor of Cardiovascular Medicine, University of Dundee, Dundee, UK.
Public study website: www.allheartstudy.org
REC name
East of Scotland Research Ethics Service REC 2
REC reference
13/ES/0104
Date of REC Opinion
12 Sep 2013
REC opinion
Favourable Opinion