RecruitingNot ApplicableNCT06995391

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


Sponsor

University of California, San Francisco

Enrollment

1,000 participants

Start Date

Apr 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Inclusion Criteria6

  • 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)
  • Have consumed alcohol at least once per month on average in the past year
  • Willing to receive messaging encouraging alcohol abstinence

Exclusion Criteria6

  • Non-english speaker
  • Currently pregnant or trying to get pregnant
  • A healthcare professional's instruction to avoid alcohol (for any reason)
  • Currently incarcerated
  • Permanent AF (meaning a medical determination has been made that sinus rhythm would definitely never be pursued in this patient)
  • Are unable to read or sign to provide informed consent

Interventions

BEHAVIORALContemporary Guideline-Adherence

Participants 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.

BEHAVIORALAlcohol Abstinence

Participants randomized to Alcohol Abstinence will receive weekly app and text-based messaging encouraging avoiding all alcohol consumption.


Locations(1)

UCSF Medical Center at Parnassus

San Francisco, California, United States

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NCT06995391


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