Health TrialsbyHealthPanel

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

ConditionsAtrial Fibrillation (AF)Atrial Fibrillation (Paroxysmal)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Alcohol Consumption Randomized Instructions

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Alcohol Non-Avoidance Case-Crossover ArmExperimental treatment 1 intervention
Group B: Alcohol Avoidance Case-Crossover ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Presence or Absence of Discrete Atrial Fibrillation Episodes

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.

Time frame
2 weeks

Secondary outcomes

1

As-Treated Relationships versus the Presence of AFib

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.

Time frame
2 weeks
2

Daily Glucose Levels

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.

Time frame
2 weeks
3

Step Counts

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.

Time frame
2 weeks
4

Sleep Duration

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.

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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