moderate alcohol and cardiovascular health trial

Conditions: Cardiovascular Diseases; Diabetes

Summary: the moderate alcohol and cardiovascular health trial (mach15) is a multicenter, worldwide, randomized clinical trial of \~15 gm of alcohol daily versus abstention, using a balanced parallel design and single-blind assessment of all outcomes among approximately 7,800 participants aged 50 years and older with advanced cardiovascular risk. intervention will average 6 years in duration with a common close-out date. following recruitment and pre-screening, participants will attend a screening visit followed by a two-week abstention washout period, a baseline visit and randomization, and subsequent visits at 3 months, 6 months, 12 months, and then annually until close-out.


Eligibility criteria:
inclusion criteria: * age ≥50 years at screening * postmenopausal, defined as 12 consecutive months without menstruation * not alcohol naïve, defined by having consumed at least one drink of alcohol in the past five years * high risk for the occurrence of a new cardiovascular disease event, defined as having any one of the following: 1. american heart association (aha)/american college of cardiology (acc) risk score ≥15% within the past 24 months (among those without clinical or subclinical cardiovascular disease \[cvd\]) 2. clinical cvd (more than 6 months prior to randomization), defined by: 1. previous myocardial infarction (mi), percutaneous coronary intervention (pci), coronary artery bypass grafting (cabg), carotid endarterectomy (ce), carotid stenting; 2. peripheral artery disease (pad) with revascularization; 3. acute coronary syndrome with or without resting electrocardiogram (ecg) change, ecg changes on a graded exercise test (gxt), or positive cardiac imaging study; 4. prior stroke documented on brain imaging or with a persistent deficit. 3. subclinical cvd, confirmed in available medical records: 1. at least a 50% diameter stenosis of a coronary, carotid, or lower extremity artery; 2. coronary artery calcium score ≥400 agatston units; 3. ankle brachial index (abi) ≤0.90; 4. left ventricular hypertrophy (lvh) by ecg (based on computer reading), echocardiogram report, or other cardiac imaging procedure report; 5. abdominal aortic aneurysm (aaa) ≥5 cm with or without repair. exclusion criteria: * high alcohol consumption, defined by any one of the following: 1. alcohol use disorders identification test (audit) score \>5 at screening 2. drinking, on average, \>7 alcoholic beverages/week during the past 6 months 3. drinking 6 or more alcoholic beverages on one occasion during the past 6 months * yale-brown obsessive compulsive scale-heavy drinking (y-bocs-hd) total score of ≥6 on questions 7, 8, and 10 * cardiovascular disease event (mi, revascularization procedure, or stroke) within the 6 months prior to randomization * aha class iii-iv heart failure * history of alcohol or substance abuse (medical record confirmed or self-reported history) * other intolerance or allergy to alcohol * dual antiplatelet therapy * history of gastric bypass surgery * any serious chronic liver disease (e.g., active hepatitis b and c infections) or liver tests (aspartate aminotransferase \[ast\], alanine aminotransferase \[alt\] and gamma-glutamyl transpeptidase \[ggt\]) \>2 times the upper limit of the normal range using local standards * personal history of any colon or liver cancer * any other cancer with a life expectancy of less than 3 years * diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy * mother or sister ever diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy * estimated glomerular filtration rate (egfr) \<30 ml/min /1.73m2 or end-stage renal disease (esrd) * ongoing use of any medication for which alcohol consumption is contraindicated * a patient health questionnaire (phq-9) ≥15 at screening * history of any organ transplant * unintentional weight loss \>10% in last 6 months * currently participating in another clinical trial (intervention trial) with cvd outcomes. note: participant must wait until the completion of his/her activities or the completion of the other trial before being screened for mach15. local restrictions for entry by participants can be more conservative if mandated. * not willing or able to provide a name and contact information for at least one additional contact person other than self * investigator discretion regarding appropriateness of participation or concern about intervention adherence, including: 1. moderate - severe psychiatric illness 2. behavioral concerns regarding likelihood of low adherence to trial protocol 3. a medical condition likely to limit survival to less than 3 years 4. advanced chronic disease, such as dementia, that requires 24-hour care * not willing or able to provide a signed and dated informed consent form * not willing or able to comply with all trial procedures.

Keywords: cardiovascular, alcohol, diabetes