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NCT06754176 | NOT YET RECRUITING | Atrial Fibrillation (AF)

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

University of California, San Francisco

Brief 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.

Condition or disease

Atrial Fibrillation (AF)

Atrial Fibrillation (Paroxysmal)

Intervention/treatment

Alcohol Consumption Randomized Instructions

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : SINGLE
Primary Purpose : OTHER
Official Title : Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)
Actual Study Start Date : 2025-04
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2029-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation

    Location Details

    NCT06754176

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, California

    UCSF Medical Center at Parnassus

    San Francisco, California, United States, 94143

    Not yet recruiting

    United States, California

    UCSF Medical Center at Mission Bay

    San Francisco, California, United States, 94158