Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation
Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)
University of California, San Francisco
100 participants
Apr 17, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this study is to assess the short-term effects of minimal and moderate drinking on atrial fibrillation (AFib) episodes in a real-world population diagnosed with 'come-and-go'/paroxysmal AFib. The question it aims to answer is: Is there a greater occurrence of AFib episodes when participants are allowed to consume alcohol according to random assignment? Participants will: * Be given daily random assignments to avoid or not to avoid alcohol * Wear an adhesive electrocardiographic (ECG) heart monitor * Wear a wrist-worn fitness tracker * Wear an anklet transdermal alcohol monitor * Wear an adhesive glucose monitor * Complete morning and evening surveys daily Participants may be compensated up to $50 for full completion of the study. This study can be done in-person or remote.
Eligibility
Inclusion Criteria7
- Comfortable reading and writing in English
- Have a smartphone and willing and able to use the Eureka mobile application
- Currently diagnosed with paroxysmal AFib without a plan to change their AFib management during the two-week monitoring period
- At least one episode of AFib in the past month OR, in the judgement of a healthcare provider, could potentially have one episode of AF in the next month
- Drank alcohol at least 1 day/week on average in the past month
- Willing and able to be randomly assigned daily to avoid or not avoid drinking alcohol over a 2-week period
- Willing and able to provide written informed consent
Exclusion Criteria7
- Only post-operative AFib
- Greater than 40% ventricular pacing
- History of alcohol addiction or abuse determined by self-reported history or AUDIT-C score
- Intolerance to alcohol
- History of liver disease
- Currently incarcerated
- Currently pregnant or trying to get pregnant
Interventions
Alcohol Avoidance: In this intervention assignment, participants will be instructed to avoid drinking alcohol for this day. Alcohol Non-Avoidance: In this intervention assignment, participants will be allowed to drink alcohol for this day.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06754176