The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk
Spiegelman, Donna; Lovato, Laura C; Khudyakov, Polyna; Wilkens, Trine L; Adebamowo, Clement A; Adebamowo, Sally N; Appel, Lawrence J; Beulens, Joline Wj; Coughlin, Janelle W; Dragsted, Lars Ove; Edenberg, Howard J; Eriksen, Jane N; Estruch, Ramon; Grobbee, Diederick E; Gulayin, Pablo E; Irazola, Vilma; Krystal, John H; Lazo, Mariana; Murray, Margaret M; Rimm, Eric B; Schrieks, Ilse C; Williamson, Jeff D; Mukamal, Kenneth J
(2020) European Journal of Preventive Cardiology, volume 27, issue 18, pp. 1967 - 1982
(Article)
Abstract
Background: Observational studies have documented lower risks of coronary heart disease and diabetes among moderate alcohol consumers relative to abstainers, but only a randomized clinical trial can provide conclusive evidence for or against these associations. Aim: The purpose of this study was to describe the rationale and design of the
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Moderate Alcohol and Cardiovascular Health Trial, aimed to assess the cardiometabolic effects of one alcoholic drink daily over an average of six years among adults 50 years or older. Methods: This multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (∼11–15 g) daily of a preferred alcoholic beverage to abstention. The trial aimed to enroll 7800 people at high risk of cardiovascular disease. The primary composite endpoint comprised time to the first occurrence of non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalized angina, coronary/carotid revascularization, or total mortality. The trial was designed to provide >80% power to detect a 15% reduction in the risk of the primary outcome. Secondary outcomes included diabetes. Adverse effects of special interest included injuries, congestive heart failure, alcohol use disorders, and cancer. Results: We describe the design, governance, masking issues, and data handling. In three months of field center activity until termination by the funder, the trial randomized 32 participants, successfully screened another 70, and identified ∼400 additional interested individuals. Conclusions: We describe a feasible design for a long-term randomized trial of moderate alcohol consumption. Such a study will provide the highest level of evidence for the effects of moderate alcohol consumption on cardiovascular disease and diabetes, and will directly inform clinical and public health guidelines.
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Keywords: Randomized controlled trial, cardiovascular diseases, diabetes mellitus type 2, ethanol, geriatric, research design, Cardiology and Cardiovascular Medicine, Epidemiology, Journal Article
ISSN: 2047-4873
Publisher: SAGE Publications Ltd
Note: Funding Information: The authors would like to thank the volunteers for their willingness to devote considerable time and effort to the trial. We would also like to thank the many trial investigators and staff members at the clinical sites and coordinating centers who contributed to the design and conduct of this study and provided the motivation for this article. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: this work was supported by U.S. Department of Health and Human Services/National Institutes of Health grant (grant number U10AA025286). Publisher Copyright: © The European Society of Cardiology 2020. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
(Peer reviewed)