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.
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.



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.



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.



32017426, pre-results.
Medicines Monitoring Unit (MEMO) and Hypertension Research Centre, Division of Molecular and Clinical Medicine, University of Dundee and Ninewells Hospital, Dundee, UK.
Isla S
0000-0002-3680-7127
IS
Mackenzie
Glasgow Clinical Trials Unit, Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
Ian
I
Ford
Glasgow Clinical Trials Unit, Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
Andrew
A
Walker
Nottingham Centre for Digestive Disorders, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Chris
C
Hawkey
Townhead Medical Practice, Montrose, UK.
Alan
A
Begg
School of Medicine, University of Nottingham, Nottingham, UK.
Anthony
A
Avery
Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK.
Jaspal
J
Taggar
Robertson Centre for Biostatistics, Glasgow Clinical Trials Unit, University of Glasgow, Glasgow, UK.
Li
L
Wei
Division of Molecular and Clinical Medicine, University of Dundee and Ninewells Hospital, Dundee, UK.
Allan D
AD
Struthers
Medicines Monitoring Unit (MEMO) and Hypertension Research Centre, Division of Molecular and Clinical Medicine, University of Dundee and Ninewells Hospital, Dundee, UK.
Thomas M
TM
MacDonald
D000493:Allopurinol / Q000627:therapeutic use*; D005260:Female; D016166:Free Radical Scavengers / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000188:drug therapy*; D011446:Prospective Studies; D012107:Research Design; D016896:Treatment Outcome; D006113:United Kingdom
D016166:Free Radical Scavengers; D000493:Allopurinol
allopurinol; cardiovascular outcomes; quality of life; uric acid