Drinking Behaviors for Atrial Fibrillation
(FULL-PROOF Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byGregory Marcus, MD, MAS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of 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.

Eligibility Criteria

This trial is for individuals with paroxysmal atrial fibrillation, which means they have episodes of irregular heartbeat that come and go. Participants must be willing to follow daily random instructions on alcohol consumption, wear several monitoring devices including an ECG heart monitor, fitness tracker, anklet alcohol monitor, and glucose monitor, as well as complete surveys twice a day.

Inclusion Criteria

Willing and able to be randomly assigned daily to avoid or not avoid drinking alcohol over a 2-week period

Comfortable reading and writing in English

Willing and able to provide written informed consent

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Exclusion Criteria

Currently incarcerated

Currently pregnant or trying to get pregnant

I have a history of liver disease.

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Treatment Details

Interventions

Randomized instructions (Behavioral Intervention)

Trial OverviewThe study tests the effects of different drinking habits on AFib by randomly assigning participants to either avoid or not avoid alcohol each day. The impact on AFib occurrence is monitored through various wearable devices and daily surveys.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Alcohol Non-Avoidance Case-Crossover ArmExperimental Treatment1 Intervention

On a given day of the 14-day study period, participants may be randomly assigned to not avoid consuming alcohol. All participants will be instructed that any alcohol consumed should not be more than 2 drinks in a 24 hour period for men and not more than 1 drink in a 24 hour period for women. The frequency of randomization will be tailored to the baseline usual frequency of alcohol consumption: For example, those who drink an average of 4 days a week/don't drink 3 days a week will have their randomization programmed to assure an average of 7 non-drinking days over the two-week period. Participants will not receive the same randomization assignment more than two consecutive days in a row. Participants will press a button on their continuously recording ECG monitor to time-stamp every alcohol drink consumed.

Group II: Alcohol Avoidance Case-Crossover ArmExperimental Treatment1 Intervention

On a given day of the 14-day study period, participants may be randomly assigned to avoid consuming alcohol. The frequency of randomization will be tailored to the baseline usual frequency of alcohol consumption: For example, those who drink an average of 4 days a week/don't drink 3 days a week will have their randomization programmed to assure an average of 7 non-drinking days over the two-week period. Participants will not receive the same randomization assignment more than two consecutive days in a row.