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): e013774, 2016 09 08.
Article
em En
| MEDLINE
| ID: mdl-27609859
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 ANDANALYSIS:
The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600â mg daily) versus no treatment in a 11 ratio, added to usual care, in 5215 patients aged 60â years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4â 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
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Alopurinol
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Isquemia Miocárdica
Tipo de estudo:
Clinical_trials
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Guideline
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Observational_studies
/
Qualitative_research
Aspecto:
Ethics
/
Patient_preference
Limite:
Female
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Humans
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Male
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Middle aged
País/Região como assunto:
Europa
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Reino Unido