RecruitingNot ApplicableNCT06754176

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

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


Sponsor

University of California, San Francisco

Enrollment

100 participants

Start Date

Apr 17, 2025

Study Type

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

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether avoiding alcohol completely versus permitting regulated/moderate alcohol use affects the frequency of atrial fibrillation (AFib) episodes — an irregular heartbeat — in people who have paroxysmal AFib (AFib that comes and goes) and drink alcohol at least once a week. **You may be eligible if...** - You have a diagnosed case of paroxysmal AFib (not permanent) - You drank alcohol at least once a week on average in the past month - You are not planning to change your AFib treatment during the 2-week study period - You have had at least one AFib episode in the past month (or your doctor thinks you may have one soon) - You have a smartphone and can use the Eureka study app **You may NOT be eligible if...** - Your AFib only happened after a surgery - You have a history of alcohol addiction or abuse - You have liver disease or alcohol intolerance - You are pregnant or trying to become pregnant - You are currently incarcerated - More than 40% of your heartbeats come from a pacemaker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAlcohol 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

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NCT06754176


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