Atrial Fibrillation Clinical Trials

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

Status: Recruiting

Location: See all (2) locations...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 21

Healthy Volunteers: f

View:

• 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

Locations

United States

California

UCSF Medical Center at Mission Bay

RECRUITING

San Francisco

UCSF Medical Center at Parnassus

RECRUITING

San Francisco

Contact Information

Primary

Gregory M Marcus, MD, MAS

greg.marcus@ucsf.edu

415-476-5706

Backup

Hannah H Oo, BS

hannah.oo@ucsf.edu

415-476-4999

Time Frame

Start Date: 2025-04-17

Estimated Completion Date: 2029-08

Participants

Target number of participants: 100

Treatments

Experimental: Alcohol Non-Avoidance Case-Crossover Arm

On a given day of the 14-day study period, participants may be randomly assigned to not avoid consuming alcohol. All participants will be instructed that any alcohol consumed should not be more than 2 drinks in a 24 hour period for men and not more than 1 drink in a 24 hour period for women.~The frequency of randomization will be tailored to the baseline usual frequency of alcohol consumption: For example, those who drink an average of 4 days a week/don't drink 3 days a week will have their randomization programmed to assure an average of 7 non-drinking days over the two-week period. Participants will not receive the same randomization assignment more than two consecutive days in a row.~Participants will press a button on their continuously recording ECG monitor to time-stamp every alcohol drink consumed.

Experimental: Alcohol Avoidance Case-Crossover Arm

On a given day of the 14-day study period, participants may be randomly assigned to avoid consuming alcohol.~The frequency of randomization will be tailored to the baseline usual frequency of alcohol consumption: For example, those who drink an average of 4 days a week/don't drink 3 days a week will have their randomization programmed to assure an average of 7 non-drinking days over the two-week period. Participants will not receive the same randomization assignment more than two consecutive days in a row.

Related Therapeutic Areas

Atrial Fibrillation

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