The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk
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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 Nygaard; 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.
In: European Journal of Preventive Cardiology, Vol. 27, No. 18, 2020, p. 1967-1982.Research output: Contribution to journal › Journal article › Research › peer-review
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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 -
ID: 240987656