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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.

Authors

Isla S. Mackenzie

Ian Ford

Andrew Walker

Chris Hawkey

Alan Begg

Dr JASPAL TAGGAR JASPAL.TAGGAR@NOTTINGHAM.AC.UK
Professor of Primary Care and Medical Education

Li Wei

Allan D. Struthers

Thomas M. MacDonald



Abstract

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.

Citation

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 Mar 28, 2024
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 6
Issue 9
Article Number e013774
DOI https://doi.org/10.1136/bmjopen-2016-013774
Public URL https://nottingham-repository.worktribe.com/output/818639
Publisher URL http://bmjopen.bmj.com/content/6/9/e013774.abstract
Related Public URLs https://creativecommons.org/licenses/by/4.0/

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