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.
Are age 21 years or older
Have a smartphone
Are able to use the Eureka mobile application
Have a history of paroxysmal or persistent atrial fibrillation (AF)
Non-english speaker
Currently pregnant or trying to get pregnant
A healthcare professional's instruction to avoid alcohol (for any reason)
Currently incarcerated
Parallel
Contemporary Guideline-Adherence
BehavioralParticipants randomized to Contemporary Guideline-Adherence will receive weekly app and text-based messaging encouraging them not to exceed guideline-directed amounts of alcohol, as well as messaging explaining that abstinence is acceptable and may be the best way to avoid AF and that, if a participant decides to consume alcohol, a Mediterranean drinking pattern may be the most healthy.
Alcohol Abstinence
BehavioralParticipants randomized to Alcohol Abstinence will receive weekly app and text-based messaging encouraging avoiding all alcohol consumption.
Change in atrial fibrillation severity at one year
The primary outcome will be change in atrial fibrillation severity at one year, defined by a change in the Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) score from baseline to one year associated with alcohol abstinence. Based on previously reported values of clinically relevant change in AFEQT score (PMID 31092022), the investigators estimate the change in mean AFEQT score from baseline to 1 year to be 5.4±17.03 in the Alcohol Abstinence group and 0.2±15.17 in the Contemporary Guideline-Adherence group, giving a 5.2 difference between the two groups. The investigators estimate that 1,000 patients would provide \~99% power to detect this difference with as much as 30% overall attrition, and 30% crossover from abstinence to drinking regularly and 20% crossover from drinking regularly to abstinence.
Total number of negative urine ethyl glucuronide tests at one year
Abstinence will be objectively assessed via urine ethyl glucuronide (EtG) tests in a random sample of 100 participants in each group. A secondary outcome will be the total number of negative EtG tests at approximately one year.
Results of the phosphatidylethanol test at one year
At approximately one year, a blood test for phosphatidylethanol (PEth) will be obtained in a different random sample of participants in each group. A secondary outcome will be the results of the PEth test at one year.
Atrial fibrillation burden at one year, quantified by Apple Watch
Participants will have the option to connect an Apple Watch to the study mobile app to share data from their device. A secondary outcome will be atrial fibrillation burden, quantified by an Apple Watch.
Atrial fibrillation burden at one year, quantified by a cardiac device
Participants who are UCSF Health patients and have an atrial lead or implantable loop recorder will have the option to share heart rhythm data from their respective device with the study team. A secondary outcome will be atrial fibrillation burden, quantified by a cardiac device.
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University of California, San Francisco
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
