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; Ian Ford; Andrew Walker; Chris Hawkey; Alan Begg; Anthony Avery; Jaspal Taggar; Li Wei; Allan D Struthers; Thomas M MacDonald; ALL-HEART study group

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 (Lead / Corresponding author), Ian Ford, Andrew Walker, Chris Hawkey, Alan Begg, Anthony Avery, Jaspal Taggar, Li Wei, Allan D Struthers, Thomas M MacDonald, ALL-HEART study group

Research output: Contribution to journal › Article › peer-review

73 Citations (Scopus)

272 Downloads (Pure)

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.

Original language	English
Article number	e013774
Pages (from-to)	1-9
Number of pages	9
Journal	BMJ Open
Volume	6
Issue number	9
DOIs	https://doi.org/10.1136/bmjopen-2016-013774
Publication status	Published - 8 Sept 2016

ASJC Scopus subject areas

General Medicine

Access to Document

10.1136/bmjopen-2016-013774Licence: CC BY

Final Published Version
This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http:// creativecommons.org/licenses/by/4.0/
Final published version, 872 KBLicence: CC BY

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Allopurinol and Cardiovascular Outcomes in Patients with Ischaemic Heart Disease (Joint with Robertson Centre for Biostatistics, University of Nottingham and University College London)
MacDonald, T. (Investigator), Mackenzie, I. (Investigator) & Struthers, A. (Investigator)
1/09/13 → 31/08/22
Project: Research

Cite this

Mackenzie, I. S., Ford, I., Walker, A., Hawkey, C., Begg, A., Avery, A., Taggar, J., Wei, L., Struthers, A. D., MacDonald, T. M., & ALL-HEART study group (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), 1-9. Article e013774. https://doi.org/10.1136/bmjopen-2016-013774

@article{88d6410da0a6441e80fc06528aab8cf8,

title = "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",

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.",

author = "Mackenzie, {Isla S} and Ian Ford and Andrew Walker and Chris Hawkey and Alan Begg and Anthony Avery and Jaspal Taggar and Li Wei and Struthers, {Allan D} and MacDonald, {Thomas M} and {ALL-HEART study group}",

note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/",

year = "2016",

month = sep,

day = "8",

doi = "10.1136/bmjopen-2016-013774",

language = "English",

volume = "6",

pages = "1--9",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "9",

}

Mackenzie, IS, Ford, I, Walker, A, Hawkey, C, Begg, A, Avery, A, Taggar, J, Wei, L, Struthers, AD , MacDonald, TM & ALL-HEART study group 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, vol. 6, no. 9, e013774, pp. 1-9. https://doi.org/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. / Mackenzie, Isla S (Lead / Corresponding author); Ford, Ian; Walker, Andrew et al.
In: BMJ Open, Vol. 6, No. 9, e013774, 08.09.2016, p. 1-9.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

T2 - protocol of the ALL-HEART study

AU - Mackenzie, Isla S

AU - Ford, Ian

AU - Walker, Andrew

AU - Hawkey, Chris

AU - Begg, Alan

AU - Avery, Anthony

AU - Taggar, Jaspal

AU - Wei, Li

AU - Struthers, Allan D

AU - MacDonald, Thomas M

AU - ALL-HEART study group

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2016/9/8

Y1 - 2016/9/8

N2 - 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.

AB - 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.

U2 - 10.1136/bmjopen-2016-013774

DO - 10.1136/bmjopen-2016-013774

M3 - Article

C2 - 27609859

SN - 2044-6055

VL - 6

SP - 1

EP - 9

JO - BMJ Open

JF - BMJ Open

IS - 9

M1 - e013774

ER -

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

Abstract

ASJC Scopus subject areas

Access to Document

Fingerprint

Projects

Allopurinol and Cardiovascular Outcomes in Patients with Ischaemic Heart Disease (Joint with Robertson Centre for Biostatistics, University of Nottingham and University College London)

Cite this