Donna Spiegelman1, Laura C Lovato2,3, Polyna Khudyakov1,3, Trine L Wilkens4, Clement A Adebamowo5, Sally N Adebamowo5, Lawrence J Appel6, Joline Wj Beulens7,8, Janelle W Coughlin6, Lars Ove Dragsted4, Howard J Edenberg9, Jane N Eriksen4, Ramon Estruch10,3, Diederick E Grobbee11, Pablo E Gulayin11, Vilma Irazola11, John H Krystal12, Mariana Lazo6, Margaret M Murray12, Eric B Rimm1,13, Ilse C Schrieks3, Jeff D Williamson2, Kenneth J Mukamal14. 1. Harvard TH Chan School of Public Health, USA. 2. Wake Forest School of Medicine, USA. 3. Department of Internal Medicine, Hospital Clínic, IDIBAPS August Pi i Sunyer Biomedical Research Institute, University of Barcelona, Spain. 4. University of Copenhagen, Denmark. 5. Department of Epidemiology and Public Health, Greenebaum Comprehensive Cancer Center, University of Maryland, School of Medicine, USA. 6. Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA. 7. Amsterdam UMC - location VUmc, Amsterdam Cardiovascular Sciences Research Institute, Netherlands. 8. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Netherlands. 9. Indiana University School of Medicine, USA. 10. CIBER de Fisiopatología de la Obesidad y la Nutricion (CIBEROBN), Instituto de Salud Carlos III, Spain. 11. Julius Clinical, Netherlands. 12. Yale University School of Medicine, USA. 13. National Institute on Alcohol Abuse and Alcoholism, U.S. National Institutes of Health, USA. 14. Channing Laboratory, Brigham and Women's Hospital, Harvard Medical School, USA.
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.
RCT Entities:
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.
Entities:
Keywords:
Randomized controlled trial; cardiovascular diseases; diabetes mellitus type 2; ethanol; geriatric; research design
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