Avoiding Coffee for Atrial Fibrillation

(DECAF Trial)

No longer recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how coffee affects atrial fibrillation (AF), a heart condition causing irregular and often rapid heartbeats. Participants will either avoid coffee or continue drinking it for six months to determine its impact on AF recurrence after a heart procedure called cardioversion. The trial aims to discover whether coffee triggers or prevents AF episodes. It suits individuals who have experienced AF, are scheduled for cardioversion, and have consumed at least one cup of coffee daily in the past five years. As an unphased trial, this study allows participants to contribute to valuable research that could enhance understanding of lifestyle impacts on heart health.

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.

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

Research shows that drinking coffee might not increase the risk of atrial fibrillation (AF), a type of irregular heartbeat. In fact, some studies suggest that coffee might even lower the risk. Evidence indicates that people who drink more coffee tend to have a lower risk of AF. Specifically, one study found that men who drank 1 to 3 cups of coffee a day had a lower chance of developing AF.

These studies suggest that drinking coffee is generally safe and might even benefit heart rhythm. However, this trial is the first to specifically examine how coffee affects AF, aiming to provide clearer answers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how coffee consumption affects atrial fibrillation (AF), a condition typically managed with medications like beta-blockers, antiarrhythmics, or anticoagulants. Unlike these pharmaceutical treatments, this trial looks at a simple lifestyle change—either avoiding or consuming coffee—to see if it impacts AF. This approach is unique because it could offer a non-drug method to manage AF, potentially reducing reliance on medications and their side effects. Understanding the relationship between coffee and AF could lead to easy, everyday adjustments that enhance heart health.

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

This trial will compare the effects of avoiding coffee with consuming coffee on atrial fibrillation (AF). Research suggests that drinking coffee might lower the risk of AF for some individuals. A review of several studies found that coffee drinkers had a lower risk of AF. Another study showed no increased risk of AF among coffee drinkers compared to non-drinkers. Additionally, coffee might improve brain function and reduce inflammation in people with AF. However, one study found that heavy coffee drinkers had a slightly higher chance of developing AF. Overall, the evidence is mixed, but many studies suggest coffee might not be as risky for AF as once thought. ^{1 2 6 7 8}

Who Is on the Research Team?

Gregory M Marcus, MD, MAS

Principal Investigator

University of California, San Francisco

Christopher X Wong, MBBS, PhD

Principal Investigator

University of Adelaide

Christopher C Cheung, MD, MPH

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Consume Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9299433/

Association of Coffee Consumption With Atrial Fibrillation ... Our evidence from this meta-analysis suggested that coffee consumption had a trend toward reducing the risk of AF in a dose–response manner.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05121519

NCT05121519 | Does Eliminating Coffee Avoid Fibrillation? The purpose of this study is to assess how abstinence of coffee compared to continued consumption affects recurrent atrial fibrillation (AF) following ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2204737

Acute Effects of Coffee Consumption on Health among ... The consumption of caffeinated coffee was associated with 58 daily premature atrial contractions as compared with 53 daily events on days when caffeine was ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.034365

Coffee Consumption Correlates With Better Cognitive ... Coffee consumption in patients with atrial fibrillation may be associated with improved cognitive performance and reduced inflammatory markers.

5. heart.org heart.org/en/news/2024/12/31/coffee-may-protect-cognition-in-people-with-afib

Coffee may protect cognition in people with AFib Drinking multiple cups of coffee each day may help prevent cognitive decline in people with a common type of heart rhythm disorder, new research suggests.

6. ahajournals.org ahajournals.org/doi/10.1161/JAHA.118.011346

Coffee Consumption and Risk of Atrial Fibrillation in the ... Our data suggest a lower risk of AF among men who reported coffee consumption of 1 to 3 cups/day.

7. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03817-x

Coffee consumption and adverse cardiovascular events in ... Coffee consumption is not associated with increased risk of atrial fibrillation: results from two prospective cohorts and a meta-analysis.

8. trialx.com trialx.com/clinical-trials/listings/271118/does-eliminating-coffee-avoid-fibrillation/

Does Eliminating Coffee Avoid Fibrillation? This pilot study will provide the first, randomized evaluation of coffee on AF outcomes and will provide important information on whether or not ...