Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study
Introduction Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive e...
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| Format: | Article |
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BMJ Publishing Group
2016
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| Online Access: | https://eprints.nottingham.ac.uk/38689/ |
| _version_ | 1848795668844380160 |
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| author | Mackenzie, Isla S. Ford, Ian Walker, Andrew Hawkey, Chris Begg, Alan Avery, Anthony Taggar, Jaspal Wei, Li Struthers, Allan D. MacDonald, Thomas M. |
| author_facet | Mackenzie, Isla S. Ford, Ian Walker, Andrew Hawkey, Chris Begg, Alan Avery, Anthony Taggar, Jaspal Wei, Li Struthers, Allan D. MacDonald, Thomas M. |
| author_sort | Mackenzie, Isla S. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Introduction
Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD.
Methods and Analysis
The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014.
Ethics and Dissemination
The study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups. |
| first_indexed | 2025-11-14T19:35:45Z |
| format | Article |
| id | nottingham-38689 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:35:45Z |
| publishDate | 2016 |
| publisher | BMJ Publishing Group |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-386892020-05-04T18:13:04Z https://eprints.nottingham.ac.uk/38689/ Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study Mackenzie, Isla S. Ford, Ian Walker, Andrew Hawkey, Chris Begg, Alan Avery, Anthony Taggar, Jaspal Wei, Li Struthers, Allan D. MacDonald, Thomas M. Introduction Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD. Methods and Analysis The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014. Ethics and Dissemination The study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups. BMJ Publishing Group 2016-09-08 Article PeerReviewed Mackenzie, Isla S., Ford, Ian, Walker, Andrew, Hawkey, Chris, Begg, Alan, Avery, Anthony, Taggar, Jaspal, Wei, Li, Struthers, Allan D. and MacDonald, Thomas M. (2016) Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study. BMJ Open, 6 (9). e013774/1-e013774/8. ISSN 2044-6055 http://bmjopen.bmj.com/content/6/9/e013774.abstract doi:10.1136/bmjopen-2016-013774 doi:10.1136/bmjopen-2016-013774 |
| spellingShingle | Mackenzie, Isla S. Ford, Ian Walker, Andrew Hawkey, Chris Begg, Alan Avery, Anthony Taggar, Jaspal Wei, Li Struthers, Allan D. MacDonald, Thomas M. Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study |
| title | Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study |
| title_full | Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study |
| title_fullStr | Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study |
| title_full_unstemmed | Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study |
| title_short | Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study |
| title_sort | multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the all-heart study |
| url | https://eprints.nottingham.ac.uk/38689/ https://eprints.nottingham.ac.uk/38689/ https://eprints.nottingham.ac.uk/38689/ |