Isla S. Mackenzie
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.
Professor TONY AVERY email@example.com
Professor of Primary Health Care
Dr JASPAL TAGGAR JASPAL.TAGGAR@NOTTINGHAM.AC.UK
Clinical Associate Professor and Head of Primary Care Undergraduate Education
Allan D. Struthers
Thomas M. MacDonald
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.
Mackenzie, I. S., Ford, I., Walker, A., Hawkey, C., Begg, A., Avery, A., …MacDonald, T. 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), Article e013774. https://doi.org/10.1136/bmjopen-2016-013774
|Journal Article Type||Article|
|Acceptance Date||Aug 15, 2016|
|Online Publication Date||Sep 8, 2016|
|Publication Date||Sep 8, 2016|
|Deposit Date||Nov 14, 2016|
|Publicly Available Date||Nov 14, 2016|
|Publisher||BMJ Publishing Group|
|Peer Reviewed||Peer Reviewed|
|Related Public URLs||https://creativecommons.org/licenses/by/4.0/|
Mackenzie BMJ Open 2016.pdf
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0
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