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

Trial Summary

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 data supports the effectiveness of the treatment Randomized instructions for atrial fibrillation?

The research suggests that lifestyle changes can modify risk factors for atrial fibrillation (AF), potentially reducing the frequency and severity of AF episodes. This implies that interventions like Randomized instructions, which may include lifestyle guidance, could be effective in managing AF. ^{1 2 3 4 5}

Is there safety data available for drinking behaviors in atrial fibrillation trials?

The research articles primarily focus on the use of oral anticoagulants for atrial fibrillation and do not provide specific safety data related to drinking behaviors. However, they do mention that real-world patients on warfarin had a similar rate of major bleeding compared to clinical trials, indicating some level of safety monitoring in these studies. ^{2 5 6 7 8}

How does the treatment 'Randomized instructions' for atrial fibrillation differ from other treatments?

The treatment 'Randomized instructions' for atrial fibrillation is unique because it focuses on modifying drinking behaviors, specifically alcohol consumption, which is known to trigger atrial fibrillation events. Unlike traditional treatments that may involve medication or surgical interventions, this approach targets lifestyle changes to manage the condition. ^{9 10 11 12 13}

What is the purpose of 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.

Research Team

Gregory Marcus, MD, MAS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Willing and able to provide written informed consent

Exclusion Criteria

Currently incarcerated

Currently pregnant or trying to get pregnant

I have a history of liver disease.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Epidemiology and modifiable risk factors for atrial fibrillation. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A clustered randomized trial to IMProve treatment with AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AF): design and rationale. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Using mobile technology to support lower-salt food choices for people with cardiovascular disease: protocol for the SaltSwitch randomized controlled trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Representation of women, older patients, ethnic, and racial minorities in trials of atrial fibrillation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Sex disparities in enrollment and reporting of outcomes by sex in contemporary clinical trials of atrial fibrillation. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Warfarin for prevention of thromboembolism in atrial fibrillation: comparison of patient characteristics and outcomes of the "Real-World" Michigan Anticoagulation Quality Improvement Initiative (MAQI2) registry to the RE-LY, ROCKET-AF, and ARISTOTLE trials. [2018]

9. Ireland pubmed.ncbi.nlm.nih.gov

Examining the lower range of the association between alcohol intake and risk of incident hospitalization with atrial fibrillation. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Alcohol consumption and 5-year change in left atrial volume among patients with coronary heart disease: results from the Heart and Soul study. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Effect of alcohol consumption on the risk of adverse events in atrial fibrillation: from the COmparison study of Drugs for symptom control and complication prEvention of Atrial Fibrillation (CODE-AF) registry. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

How Does Alcohol Intake Relate to the Risk of Atrial Fibrillation? [2020]