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

Recruiting
21 - 80 years of age
Both
Phase N/A

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Overview

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.

Description

This study is a case-crossover randomized trial, where each participant will be instructed to avoid or not avoid drinking alcohol on randomly assigned days during a 14-day monitoring period. Participants will also wear an external ECG monitor, an alcohol monitor, a continuous glucose monitor, and a fitness tracker for up to two weeks while utilizing a mobile application to receive daily instructions/reminders on drinking and short surveys. The investigators will compare participant self-report of alcohol consumption, glucose monitoring, fitness levels, sleep health, and heart rhythm data in order to better understand the immediate relationship between drinking alcohol and heart rhythm. A total of 100 participants will be enrolled.

Eligibility

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

Study details

Atrial Fibrillation (AF), Atrial Fibrillation (Paroxysmal)

NCT06754176

University of California, San Francisco

1 May 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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