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Randomized Controlled Trial
. 2016 Sep 8;6(9):e013774.
doi: 10.1136/bmjopen-2016-013774.

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

Isla S Mackenzie  1 , Ian Ford  2 , Andrew Walker  2 , Chris Hawkey  3 , Alan Begg  4 , Anthony Avery  5 , Jaspal Taggar  6 , Li Wei  7 , Allan D Struthers  8 , Thomas M MacDonald  1 ; ALL-HEART study group
Affiliations
Randomized Controlled Trial

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

Isla S Mackenzie et al. BMJ Open. .

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.

Trial registration number: 32017426, pre-results.

Keywords: allopurinol; cardiovascular outcomes; quality of life; uric acid.

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Figures

Figure 1
Figure 1
ALL-HEART study overview. In total, 5215 patients aged over 60 years with ischaemic heart disease will be randomised to receive allopurinol or no additional therapy, in addition to their usual care, then followed up for an expected average of 4 years for outcomes.
See this image and copyright information in PMC

References

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