Effects of Alcohol Consumption on Atrial Fibrillation Episodes
Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)
This study is testing whether drinking small to moderate amounts of alcohol affects how often people with paroxysmal atrial fibrillation have episodes of irregular heartbeats.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT06754176 on ClinicalTrials.gov |
What this trial studies
This study investigates the short-term effects of minimal and moderate alcohol consumption on episodes of paroxysmal atrial fibrillation (AFib) in participants. Using a case-crossover randomized design, participants will be assigned daily to either avoid or consume alcohol over a 14-day monitoring period. They will wear various monitoring devices, including an ECG monitor and an alcohol monitor, while completing daily surveys to assess their alcohol intake and heart rhythm. The goal is to determine if allowing alcohol consumption increases the occurrence of AFib episodes.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with paroxysmal AFib who consume alcohol at least once a week and are comfortable using a smartphone.
Not a fit: Patients with a history of alcohol addiction, liver disease, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safe alcohol consumption levels for patients with paroxysmal AFib.
How similar studies have performed: While there have been studies on alcohol and AFib, this specific randomized approach to assess real-time effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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 Criteria * 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
Where this trial is running
San Francisco, California and 1 other locations
- UCSF Medical Center at Parnassus — San Francisco, California, United States (Recruiting)
- UCSF Medical Center at Mission Bay — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Gregory Marcus, MD, MAS — University of California, San Francisco
- Study coordinator: Gregory M Marcus, MD, MAS
- Email: greg.marcus@ucsf.edu
- Phone: 415-476-5706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.