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

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation (AF); Atrial Fibrillation (Paroxysmal)

• Registration Number: NCT06754176
• Lead 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.

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 Timeline

• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-23
• Study First Posted: 2024-12-31
• Status Verified: 2025-04
• Study Start: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-12
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

UCSF Medical Center at Parnassus; 🇺🇸 San Francisco, California, United States

UCSF Medical Center at Mission Bay; 🇺🇸 San Francisco, California, United States