Clinical Trial

Digitally Rendered Interventions And Knowledge To Limit Ethanol-Associated Atrial Fibrillation Severity

Study acronym: DRINK-LESS
Recruiting
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Summary
Per the 2021 National Survey on Drug Use and Health administered by the U.S. Department of Health and Human Services, 85% of all American adults consume alcohol. Atrial fibrillation (AF) is the most common arrhythmia, affecting more than 10 million individuals in U.S., comprising 4.5% of the adult population. Although alcohol abstinence clearly reduces AF in heavy drinkers, observational data comparing the health effects of limited consumption versus abstention are conflicting. The Mediterranean diet is one of the few that has demonstrated clear cardiovascular benefits in a randomized study-this diet allows for the consumption of red wine (or high polyphenol/ low alcohol alcohol), generally not more than one drink in 24 hours, with meals, avoiding spirits and binge drinking. The effect of the "Mediterranean drinking pattern" on AF risk compared to alcohol abstinence remains unknown. This single center, randomized, controlled trial aims to compare the effects of a digital health intervention to encourage durable alcohol abstinence versus allowing guideline-adherent moderate alcohol consumption on AF severity. The knowledge gained from this study may be used to determine optimal thresholds for alcohol use among AF patients.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-20; most recent amendment 2025-07-28.
Trial Details
NCT Number NCT06995391
Lead Sponsor University of California, San Francisco
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Atrial Fibrillation (AF)
Enrollment 1,000 participants
Start Date 2025-04-20
Primary Completion 2030-03-01 (estimated)
Study Completion 2030-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-31