Atrial Fibrillation (AF), Atrial Fibrillation (Paroxysmal)
Conditions
Keywords
Alcohol, Drinking, Mediterranean Drinking Pattern, Atrial Fibrillation, AFib, AF, Heart Rhythm
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.
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.
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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a randomized, case-crossover trial.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence or Absence of Discrete Atrial Fibrillation Episodes | 2 weeks | Participants will be wearing a continuously recording ECG monitor for two weeks. The primary outcome will be the presence (versus absence) of at least one AFib episode on randomly assigned drinking versus non-drinking days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| As-Treated Relationships versus the Presence of AFib | 2 weeks | As-treated (whether alcohol was consumed or not according to real-time patient reports using the Zio patch button and/ or alcohol sensors) relationships versus the presence of AFib will be considered. |
| Daily Glucose Levels | 2 weeks | This will first be assessed according to intention-to-treat and then as-treated. Participants will be wearing a continuous glucose monitor that will record serum glucose levels. A secondary outcome will be difference in daily glucose levels due to alcohol consumption or avoidance during the monitoring period. |
| Step Counts | 2 weeks | This will first be assessed according to intention-to-treat and then as-treated. Participants will be wearing a fitness tracker that will record step counts. A secondary outcome will be difference in step counts due to alcohol consumption or avoidance during the monitoring period. |
| Sleep Duration | 2 weeks | This will first be assessed according to intention-to-treat and then as-treated. Participants will be wearing a fitness tracker that will record sleep duration. A secondary outcome will be difference in sleep duration due to alcohol consumption or avoidance during the monitoring period. |
Countries
United States
Contacts
Primary ContactGregory M Marcus, MD, MAS
Backup ContactHannah H Oo, BS
Outcome results
None listed