NCT06995391 Digitally Rendered Interventions And Knowledge To Limit Ethanol-Associated Atrial Fibrillation Severity
| NCT ID | NCT06995391 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-04-20 |
| Primary Completion | 2030-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2025-04-20 with a primary completion date of 2030-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Gregory M Marcus, MD, MAS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06995391 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06995391 currently recruiting?
Yes, NCT06995391 is actively recruiting participants. Contact the research team at greg.marcus@ucsf.edu for enrollment information.
Where is the NCT06995391 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06995391 clinical trial?
NCT06995391 is sponsored by University of California, San Francisco. The principal investigator is Gregory M Marcus, MD, MAS at University of California, San Francisco. The trial plans to enroll 1,000 participants.
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