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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
  1. Isla S Mackenzie1,
  2. Ian Ford2,
  3. Andrew Walker2,
  4. Chris Hawkey3,
  5. Alan Begg4,
  6. Anthony Avery5,
  7. Jaspal Taggar6,
  8. Li Wei7,
  9. Allan D Struthers8,
  10. Thomas M MacDonald1,
  11. on behalf of the ALL-HEART study group
  1. 1Medicines Monitoring Unit (MEMO) and Hypertension Research Centre, Division of Molecular and Clinical Medicine, University of Dundee and Ninewells Hospital, Dundee, UK
  2. 2Glasgow Clinical Trials Unit, Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK
  3. 3Nottingham Centre for Digestive Disorders, Nottingham University Hospitals NHS Trust, Nottingham, UK
  4. 4Townhead Medical Practice, Montrose, UK
  5. 5School of Medicine, University of Nottingham, Nottingham, UK
  6. 6Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK
  7. 7Robertson Centre for Biostatistics, Glasgow Clinical Trials Unit, University of Glasgow, Glasgow, UK
  8. 8Division of Molecular and Clinical Medicine, University of Dundee and Ninewells Hospital, Dundee, UK
  1. Correspondence to Dr Isla S Mackenzie; i.s.mackenzie{at}


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.

  • allopurinol
  • cardiovascular outcomes
  • quality of life
  • uric acid

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