Drinking Behaviors for Atrial Fibrillation

(FULL-PROOF Trial)

Recruiting at 1 trial location

Overseen By Hannah H Oo, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Post-operative AFib, Alcohol addiction, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how alcohol consumption might trigger episodes of atrial fibrillation (AFib), a condition characterized by an irregular heartbeat. Participants will receive daily randomized instructions on whether to avoid alcohol and will wear several monitors to track heart activity and alcohol consumption over two weeks. Eligible participants should have paroxysmal AFib, have experienced a recent episode or be likely to have one soon, and consume alcohol at least once a week. The trial aims to determine if alcohol consumption increases the frequency of AFib episodes. Participants may receive up to $50 for completing the study. As an unphased trial, this study offers a unique opportunity to contribute to understanding the relationship between alcohol consumption and AFib episodes, potentially benefiting future patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you do not plan to change your AFib management during the two-week monitoring period.

What prior data suggests that this protocol is safe for participants?

Past research has not fully clarified the safety of consuming up to two alcoholic drinks a day for people with atrial fibrillation (AFib). Some studies have shown that even small amounts of alcohol can increase the risk of AFib episodes, with this risk appearing higher in men than in women.

This study will involve only minimal to moderate drinking, defined as no more than two drinks a day for men and one drink a day for women. This controlled approach aims to better understand the short-term effects on AFib episodes while keeping alcohol consumption within a moderate range.

Researchers will closely monitor participants using devices like heart monitors and fitness trackers to ensure safety and collect accurate data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a fresh approach to understanding atrial fibrillation (AFib) in relation to alcohol consumption. Unlike traditional treatments for AFib, which often focus on medication to control heart rhythm or rate, this study examines how modifying drinking behavior might impact the condition. By using randomized instructions for alcohol consumption, the trial aims to explore whether strategic avoidance or limited intake can reduce AFib episodes. This could lead to personalized lifestyle recommendations that complement existing medical therapies, offering a non-pharmacological way to manage AFib.

What evidence suggests that this trial's treatments could be effective for atrial fibrillation?

Research has shown that drinking alcohol can increase the risk of atrial fibrillation (AFib), a condition where the heart beats irregularly. One study found that each additional drink per day raises the risk of AFib by 6%. Another study demonstrated that alcohol consumption can trigger an AFib episode within a few hours. Even small amounts of alcohol might affect AFib, though the risk is lower. This trial will compare two approaches: one where participants avoid alcohol and another where they do not, to assess the impact on heart rhythm. These findings suggest that alcohol can significantly affect heart rhythm, especially in individuals already diagnosed with paroxysmal AFib, where the condition comes and goes. ^{3 4 6 7 8}

Who Is on the Research Team?

Gregory Marcus, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals with paroxysmal atrial fibrillation, which means they have episodes of irregular heartbeat that come and go. Participants must be willing to follow daily random instructions on alcohol consumption, wear several monitoring devices including an ECG heart monitor, fitness tracker, anklet alcohol monitor, and glucose monitor, as well as complete surveys twice a day.

Inclusion Criteria

I have a smartphone and can use the Eureka app.

Willing and able to be randomly assigned daily to avoid or not avoid drinking alcohol over a 2-week period

Comfortable reading and writing in English

Exclusion Criteria

Currently incarcerated

Currently pregnant or trying to get pregnant

I have a history of liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to avoid or not avoid alcohol during a 14-day monitoring period while wearing various monitors and completing surveys

2 weeks

Remote or in-person participation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Randomized instructions

Trial Overview The study tests the effects of different drinking habits on AFib by randomly assigning participants to either avoid or not avoid alcohol each day. The impact on AFib occurrence is monitored through various wearable devices and daily surveys.

How Is the Trial Designed?

Group I: Alcohol Non-Avoidance Case-Crossover Arm Experimental Treatment 1 Intervention

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.

Group II: Alcohol Avoidance Case-Crossover Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9561500/

Alcohol consumption and atrial fibrillation risk The overall meta-analysis showed that a 1 drink/day increase in alcohol consumption increased the risk of AF by 6% (RR: 1.06; 95% CI: 1.03–1.08) (Figure 2).

2. sciencedirect.com sciencedirect.com/science/article/pii/S0735109716364695

Alcohol and Atrial Fibrillation: A Sobering Review Habitual alcohol consumption predisposes to AF by direct effects on left atrial substrate and interaction with other AF risk factors, including hypertension, ...

3. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.802163/full

Alcohol Consumption and Risk of Atrial Fibrillation: A Dose ... Our study supported that low alcohol consumption (primarily 0–12 g/day) might be a potentially safe threshold for AF risk. Alcohol showed a ...

4. academic.oup.com academic.oup.com/eurjpc/article/31/1/49/7261670

Changes in alcohol consumption habits and risk of atrial ... The incidence rates of sustained heavy drinking, reduced drinking, and absolute abstinence were 4.4, 4.9, and 4.1 per 1000 person-years, respectively.

5. acc.org acc.org/latest-in-cardiology/journal-scans/2021/09/06/21/43/acute-consumption-of-alcohol

Alcohol Consumption and Discrete Atrial Fibrillation Events The present study shows that alcohol consumption substantially increases the chance of a discrete AF episode within a few hours after drinking.

6. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001341

Alcohol Use and Cardiovascular Disease: A Scientific ... The risk associated with consuming 1 to 2 drinks a day on atrial fibrillation remains unknown. More randomized trials of low to moderate alcohol ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11264018/

Alcohol and Atrial Fibrillation - PMC [35] found that for liquor, the risk of AF was increased when drinking 7–14 and > 14 units of alcohol/week; while in the case of wine, consumption > 14 alcohol ...

8. academic.oup.com academic.oup.com/eurheartj/article/42/12/1170/6090248

Alcohol consumption, cardiac biomarkers, and risk of atrial ... Alcohol consumption across common types of alcoholic beverages and drinking patterns was associated with an increased AF risk even at low doses.