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

Plain Language Summary

Simplified for easier understanding

This study uses a smartphone app to send educational messages and support to people with atrial fibrillation (an irregular heartbeat) who also drink alcohol, to test whether reducing alcohol intake can reduce the severity of their AF episodes. **You may be eligible if...** - You are 21 or older - You have been diagnosed with paroxysmal (comes and goes) or persistent atrial fibrillation - You drink alcohol at least once a month on average - You have a smartphone and can use the Eureka app - You are willing to receive messages encouraging you to stop drinking alcohol **You may NOT be eligible if...** - You do not speak English - You are pregnant or trying to get pregnant - A doctor has told you to avoid alcohol for any medical reason - You are currently incarcerated - You have permanent AF (your doctors have decided sinus rhythm will never be pursued) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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