Avoiding Coffee for Atrial Fibrillation

(DECAF Trial)

Overseen By Greg Marcus, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Pregnancy, Recent surgery, AF ablation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Given both the increasing population impact of atrial fibrillation (AF) and the widespread consumption of coffee in society, determining an associated benefit or risk of coffee consumption on AF is of great clinical relevance. This pilot study will evaluate the effect of randomly assigning participants undergoing electrical cardioversion to coffee abstinence or coffee consumption over a 6 month period. This pilot study will provide the first, randomized evaluation of coffee on AF outcomes and will provide important information on whether or not coffee has any effect on AF recurrence.

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

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on coffee consumption, so it's best to discuss your medications with the study team.

What data supports the effectiveness of the treatment 'Avoid coffee, Consume coffee' for atrial fibrillation?

Research suggests that moderate coffee consumption (1 to 3 cups per day) may be linked to a lower risk of atrial fibrillation, as seen in the Physicians' Health Study, which found a lower risk among men who drank this amount. ^{1 2 3 4 5}

Is avoiding coffee safe for humans?

The research does not provide specific safety data on avoiding coffee, but studies suggest that moderate coffee consumption is generally not linked to an increased risk of atrial fibrillation, indicating it is likely safe to avoid coffee. ^{1 2 3 4 5}

How does avoiding or consuming coffee affect atrial fibrillation compared to other treatments?

This treatment is unique because it focuses on the impact of coffee consumption, which is a common dietary habit, rather than using medication or medical procedures. The research suggests that moderate coffee consumption might be associated with a lower risk of atrial fibrillation, but findings are inconsistent, making this approach different from standard medical treatments. ^{2 3 4 5 6}

Research Team

Chris Wong, MD

Principal Investigator

University of California, San Francisco

Greg Marcus, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for men and women over 21 who have atrial fibrillation, drink coffee daily, and are scheduled for electrical cardioversion. They must be willing to either abstain from or continue drinking coffee and attend follow-up calls. Exclusions include allergies to coffee, recent heart surgeries, pregnancy plans within six months, or participation in conflicting studies.

Inclusion Criteria

I have ongoing atrial fibrillation.

I can attend all scheduled phone follow-ups.

I am 21 years old or older.

Exclusion Criteria

Any other criteria, which would make the patient unsuitable to participate in this study as determined by the Principal Investigator (e.g., an uncontrolled drug and/or alcohol addiction)

I had a procedure to correct heart rhythm due to atrial flutter, not AF.

Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either abstain from coffee or continue coffee consumption for up to 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on AF recurrence and other arrhythmias

6 months

Treatment Details

Interventions

• Avoid coffee
• Consume coffee

Trial Overview The study tests the impact of coffee on atrial fibrillation by randomly assigning participants to two groups: one that avoids coffee and another that continues consumption post-electrical cardioversion. The goal is to see if avoiding or consuming coffee affects AF recurrence over a six-month period.

Participant Groups

Group I: Consume Experimental Treatment 1 Intervention

Patients will undergo this intervention for up to 6 months, or whenever their AF returns, whichever comes first.

Group II: Avoid Experimental Treatment 1 Intervention

Patients will undergo this intervention for up to 6 months, or whenever their AF returns, whichever comes first.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

References

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

Coffee consumption is not associated with increased risk of atrial fibrillation: results from two prospective cohorts and a meta-analysis. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Coffee Consumption and Risk of Atrial Fibrillation in the Physicians' Health Study. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Influence of coffee and caffeine consumption on atrial fibrillation in hypertensive patients. [2015]

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

Risk of atrial fibrillation associated with coffee intake: Findings from the Danish Diet, Cancer, and Health study. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Caffeinated coffee consumption and risk of atrial fibrillation in two Spanish cohorts. [2021]

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

Intermittent Nonhabitual Coffee Consumption and Risk of Atrial Fibrillation: The Multi-Ethnic Study of Atherosclerosis. [2022]