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NCT06995391: DRINK-LESS

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

Recruiting now NA Last updated 31 July 2025
What this trial tests

NA trial testing Contemporary Guideline-Adherence in Atrial Fibrillation (AF) in 1,000 participants. Currently enrolling.

Timeline
20 April 2025
Primary endpoint
1 March 2030
1 March 2030

Quick facts

Lead sponsorUniversity of California, San Francisco
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment1,000
Start date20 April 2025
Primary completion1 March 2030
Estimated completion1 March 2030
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

21 and older, any sex, with Atrial Fibrillation (AF). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Atrial Fibrillation (AF)

Currently open trials in the same condition.

Other University of California, San Francisco trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing