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RECRUITINGINTERVENTIONAL

Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation

Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

Alcohol Consumption Randomized Instructions

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)

UCSF Medical Center at Parnassus
San Francisco, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States