Alcohol Abstinence for Atrial Fibrillation

(DRINK-LESS Trial)

Overseen By Gabrielle C Montenegro, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-english speaker, Pregnant, Incarcerated, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how varying levels of alcohol consumption affect individuals with atrial fibrillation (AF), a common heart rhythm issue. It compares those who completely quit alcohol (alcohol abstinence) to those who drink moderately, following the Mediterranean drinking pattern, which includes wine with meals and no binge drinking. The goal is to determine which approach reduces AF symptoms. Suitable participants have a history of AF and consume alcohol at least once a month. Participants receive app-based messages to guide their drinking habits, and their progress is tracked through surveys and tests. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance AF management strategies.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that giving up alcohol can reduce episodes of atrial fibrillation (AF). One study found that individuals who stopped drinking had a 53% chance of AF returning, while those who continued had a 73% chance. Another study found a 63% lower risk of AF in those who completely quit drinking compared to those who did not.

Conversely, moderate drinking, such as consuming small amounts of red wine with meals, is part of the Mediterranean diet, known for its heart benefits. However, the impact of this drinking pattern on AF compared to abstaining remains unclear.

Both options—completely stopping alcohol or drinking in moderation according to guidelines—are under study for their effects on AF. Current research supports the safety and potential heart benefits of both methods. However, choosing between them should consider personal health and lifestyle choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these strategies for managing atrial fibrillation (AF) because they focus on lifestyle changes rather than medications or surgeries. One approach promotes alcohol abstinence, using app and text reminders to help participants avoid drinking entirely, which could reduce AF episodes by eliminating alcohol as a trigger. The other approach encourages participants to follow contemporary drinking guidelines, suggesting moderate consumption and a Mediterranean drinking pattern, which could offer a balanced way to manage AF risk while still allowing some alcohol consumption. Both strategies are innovative in that they utilize digital tools for ongoing support and real-time feedback, potentially making them more adaptable and accessible than traditional methods.

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

Research has shown that stopping alcohol can greatly reduce the chances and impact of atrial fibrillation (AF) in regular drinkers. One study found that people who completely stopped drinking had a 63% lower chance of developing AF. Another study demonstrated that those who quit drinking experienced fewer AF episodes than those who continued. This trial will compare two approaches: one arm will focus on Alcohol Abstinence, encouraging participants to avoid all alcohol consumption, while the other arm will follow Contemporary Guideline-Adherence, where participants receive guidance on not exceeding guideline-directed amounts of alcohol. Some studies indicate that drinking small to moderate amounts of alcohol might lower the risk of death in people with AF, but the effect on AF itself remains unclear. Thus, avoiding alcohol appears to be a safer choice for reducing AF episodes. ^{3 6 7 8 9}

Who Is on the Research Team?

Gregory M Marcus, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for U.S. adults with atrial fibrillation (AF), the most common heart rhythm disorder. Participants should be current alcohol consumers, willing to either abstain from alcohol or follow a Mediterranean drinking pattern as per study assignment.

Inclusion Criteria

Willing to receive messaging encouraging alcohol abstinence

Have consumed alcohol at least once per month on average in the past year

Have a smartphone

Exclusion Criteria

A healthcare professional's instruction to avoid alcohol (for any reason)

Are unable to read or sign to provide informed consent

Non-english speaker

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 one of two digital health interventions for one year, receiving weekly app and text-based messaging regarding alcohol consumption.

52 weeks

Weekly digital interactions

Follow-up

Participants are monitored for changes in atrial fibrillation severity and burden, with assessments including surveys and optional device data sharing.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol Abstinence
• Contemporary Guideline-Adherence

Trial Overview The DRINK-LESS trial is testing whether completely stopping alcohol use or adhering to moderate consumption following the Mediterranean diet guidelines affects AF severity differently. It's a controlled study where participants are randomly assigned to one of two digital health interventions.

How Is the Trial Designed?

Group I: Contemporary Guideline-Adherence Experimental Treatment 1 Intervention

Participants randomized to Contemporary Guideline-Adherence will receive weekly app and text-based messaging encouraging them not to exceed guideline-directed amounts of alcohol, as well as messaging explaining that abstinence is acceptable and may be the best way to avoid AF and that, if a participant decides to consume alcohol, a Mediterranean drinking pattern may be the most healthy. Alcohol consumption (or abstinence) and AF episodes and severity will be assessed by serial surveys. Abstinence will also be objectively assessed via urine ethyl glucuronide (EtG) tests and a blood test for phosphatidylethanol (PEth) in randomly selected participants.

Group II: Alcohol Abstinence Experimental Treatment 1 Intervention

Participants randomized to Alcohol Abstinence will receive weekly app and text-based messaging encouraging avoidance of all alcohol consumption. Those assigned to this arm will also have the option to opt-in or decline to participate in additional messaging and surveys discouraging the purchase of alcohol triggered by visits to establishments that sell alcohol (bars and liquor stores) for the first month of the study. Alcohol consumption (or abstinence) and AF episodes and severity will be assessed by serial surveys. Abstinence will also be objectively assessed via urine ethyl glucuronide (EtG) tests and a blood test for phosphatidylethanol (PEth) in randomly selected participants.

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/PMC9074049/

Alcohol abstinence reduces A-fib burden in drinkers - PMC A recent Australian study demonstrated a significant reduction in A-fib recurrence and burden among regular drinkers who abstained from alcohol.

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

Changes in alcohol consumption habits and risk of atrial ... Overall, 19 425 participants were evaluated. The absolute abstinence group showed a 63% lower incidence of AF (IPTW hazard ratio: 0.379, 95% ...

3. nejm.org nejm.org/doi/abs/10.1056/NEJMoa1817591

Alcohol Abstinence in Drinkers with Atrial Fibrillation After a 2-week blanking period, atrial fibrillation recurred in 37 of 70 patients (53%) in the abstinence group and in 51 of 70 patients (73%) ...

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

Alcohol and Atrial Fibrillation: A Sobering Review Alcohol intake post-PVI predicted recurrent AF (recurrence rate 64.9% women >7 standard drinks/week and men >14 standard drinks/week; 30.8% for women 1-7 ...

5. ahajournals.org ahajournals.org/doi/10.1161/circ.146.suppl_1.10284

Abstract 10284: Alcohol Consumption and Cardiovascular ... Conclusion: As compared to non-drinkers, light and moderate alcohol drinking in patients with AF are associated with a lower risk of mortality ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa1817591

Alcohol Abstinence in Drinkers with Atrial Fibrillation After a 2-week blanking period, atrial fibrillation recurred in 37 of 70 patients (53%) in the abstinence group and in 51 of 70 patients (73%) ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31893513/

Alcohol Abstinence in Drinkers with Atrial Fibrillation Conclusions: Abstinence from alcohol reduced arrhythmia recurrences in regular drinkers with atrial fibrillation. (Funded by the Government of ...

8. acc.org acc.org/latest-in-cardiology/clinical-trials/2019/03/17/00/04/alcohol-af

Impact of Alcohol Abstinence in Moderate Drinkers With ... The co-primary outcome, atrial fibrillation recurrence, occurred in 53% of the abstinence group compared with 73% of the usual consumption ...

9. jacc.org jacc.org/doi/10.1016/j.jacep.2021.05.013

Risk Thresholds for Total and Beverage-Specific Alcohol ... This study sought to characterize associations of total and beverage-specific alcohol consumption with incident atrial fibrillation (AF).