The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk
Year: 2020
Type: 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 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.
Authors: Donna Spiegelman, Laura C Lovato, Polyna Khudyakov, Trine L Wilkens, Clement A Adebamowo, Sally N Adebamowo, Lawrence J Appel, Joline WJ Beulens, Janelle W Coughlin, Lars Ove Dragsted, Howard J Edenberg, Jane N Eriksen, Ramon Estruch, Diederick E Grobbee, Pablo E Gulayin, Vilma Irazola, John H Krystal, Mariana Lazo, Margaret M Murray, Eric B Rimm, Ilse C Schrieks, Jeff D Williamson, Kenneth J Mukamal
Institutions: Harvard University, Hospital Clínic de Barcelona, Consorci Institut D'Investigacions Biomediques August Pi I Sunyer, Wake Forest University Health Sciences, Wake Forest University, Universitat de Barcelona, University of Copenhagen, University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Johns Hopkins University, Utrecht University, University Medical Center Utrecht, Amsterdam Cardiovascular Sciences, Amsterdam UMC Location Vrije Universiteit Amsterdam, Indiana University School of Medicine, Instituto de Salud Carlos III, Spanish Biomedical Research Centre in Physiopathology of Obesity and Nutrition, Julius Clinical Research BV (Netherlands), Yale University, National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, Brigham and Women's Hospital
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W3014408124