Summary

Eligibility
for people ages 21-80 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Gregory Marcus, MD, MAS (ucsf)
Headshot of Gregory Marcus
Gregory Marcus

Description

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.

Official Title

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

Details

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.

Keywords

Atrial Fibrillation (AF), Atrial Fibrillation (Paroxysmal), Alcohol, Drinking, Mediterranean Drinking Pattern, Atrial Fibrillation, AFib, AF, Heart Rhythm, Randomized instructions

Eligibility

You can join if…

Open to people ages 21-80

  • 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
  • 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

You CAN'T join if...

  • Only post-operative AFib
  • 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

Locations

  • UCSF Medical Center at Parnassus
    San Francisco California 94143 United States
  • UCSF Medical Center at Mission Bay
    San Francisco California 94158 United States

Lead Scientist at University of California Health

  • Gregory Marcus, MD, MAS (ucsf)
    Dr. Gregory Marcus is a specialist in the treatment of arrhythmias, including mapping and catheter ablation for atrial fibrillation, supraventricular tachycardias and ventricular arrhythmias. He is also an expert in pacemaker, biventricular device and defibrillator implantation. RESEARCH Dr. Marcus is Associate Chief of Cardiology for Research at UCSF Health. He is also an Ass…

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06754176
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated