TY - JOUR

T1 - The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk

AU - Spiegelman, Donna

AU - Lovato, Laura C

AU - Khudyakov, Polyna

AU - Wilkens, Trine L

AU - Adebamowo, Clement A

AU - Adebamowo, Sally N

AU - Appel, Lawrence J

AU - Beulens, Joline Wj

AU - Coughlin, Janelle W

AU - Dragsted, Lars Ove

AU - Edenberg, Howard J

AU - Eriksen, Jane Nygaard

AU - Estruch, Ramon

AU - Grobbee, Diederick E

AU - Gulayin, Pablo E

AU - Irazola, Vilma

AU - Krystal, John H

AU - Lazo, Mariana

AU - Murray, Margaret M

AU - Rimm, Eric B

AU - Schrieks, Ilse C

AU - Williamson, Jeff D

AU - Mukamal, Kenneth J

N1 - CURIS 2020 NEXS 136

PY - 2020

Y1 - 2020

N2 - 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 cardiovasculardisease and diabetes, and will directly inform clinical and public health guidelines.

AB - 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 cardiovasculardisease and diabetes, and will directly inform clinical and public health guidelines.

KW - Faculty of Science

KW - Randomized controlled trial

KW - Ethanol

KW - Cardiovascular diseases

KW - Diabetes mellitus type 2

KW - Geriatric

KW - Research design

U2 - 10.1177/2047487320912376

DO - 10.1177/2047487320912376

M3 - Journal article

C2 - 32250171

VL - 27

SP - 1967

EP - 1982

JO - European Journal of Preventive Cardiology

JF - European Journal of Preventive Cardiology

SN - 2047-4873

IS - 18

ER -