Caffeine for Atrial Fibrillation

Not yet recruiting at 8 trial locations

Overseen By Donita Atkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kansas City Heart Rhythm Research Foundation

Must not be taking: Amiodarone, AAD

Disqualifiers: Substance abuse, Alcoholism, Pregnancy, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how caffeine affects heart rhythm in people with Atrial Fibrillation (AF), a condition characterized by irregular heartbeats. Participants will receive either intravenous caffeine (a direct injection of caffeine into the bloodstream) or a placebo for comparison. The trial specifically targets individuals who have recently developed AF and are undergoing a procedure called AF ablation for treatment. It may suit those experiencing new symptoms of irregular heartbeats and already planning an ablation procedure. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance understanding and treatment of AF.

Will I have to stop taking my current medications?

The trial requires that you stop taking amiodarone at least 1 month before the procedure and any antiarrhythmic drugs (AAD) 24 hours before the procedure.

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

Research has shown that caffeine might be safer for the heart than many people think. Studies indicate that caffeine does not increase the risk of atrial fibrillation (AF), a heart rhythm problem. In fact, some studies suggest that caffeine might even reduce the chance of AF occurring. For example, research in both humans and animals found that caffeine can make it harder for AF to start. This is surprising because caffeine is often thought to cause heart issues.

In another study, women who consumed a lot of caffeine did not have a higher risk of developing AF. Even drinking coffee, a common source of caffeine, doesn't seem to increase the risk of AF in the general population. This evidence suggests that caffeine is generally safe for heart health, at least regarding AF. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using intravenous caffeine for atrial fibrillation because it offers a unique approach compared to typical treatments like beta-blockers or calcium channel blockers. Unlike these standard medications, which often aim to slow down the heart rate, caffeine targets the heart's electrical system more directly. This new delivery method through intravenous administration could potentially provide rapid results, offering an innovative angle for managing atrial fibrillation. If successful, it could expand the toolkit for cardiologists looking for fast-acting solutions.

What evidence suggests that this trial's treatments could be effective for Atrial Fibrillation?

This trial will compare the effects of intravenous caffeine with a masked placebo on atrial fibrillation (AF). Studies have shown mixed results regarding caffeine's impact on heart rhythms. Some research suggests that intravenous caffeine might lower the chance of AF in certain cases. One study found that drinking coffee did not increase the risk of AF. However, another study noted a slight increase in early heartbeats on days when caffeine was consumed. Overall, the evidence varies, and more research is needed to understand caffeine's exact role in heart rhythm changes. ^{1 2 3 6 7}

Who Is on the Research Team?

Dhanunjaya Lakkireddy

Principal Investigator

Kansas City Heart Rhythm Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 21-90 with new or recent onset Paroxysmal Atrial Fibrillation, who are undergoing AF ablation and can give informed consent. It's not for those with substance abuse history, severe caffeine intolerance, pregnancy, poor heart pump function (ejection fraction <50%), liver issues, or recent use of certain heart rhythm drugs.

Inclusion Criteria

Adults between 21 and 90 years old with new episodes of Paroxysmal Atrial Fibrillation will be part of the study if they are having a procedure called AF ablation.

Exclusion Criteria

History of substance abuse or alcoholism

You have a strong negative reaction to caffeine.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous caffeine or placebo during pulmonary vein isolation procedures to assess atrial activity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intravenous caffeine
• Masked Placebo

Trial Overview The study tests the effects of intravenous caffeine on atrial electrical properties and arrhythmia risk during pulmonary vein isolation procedures in AF patients. Participants will be randomly assigned to receive either caffeine or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Group assigned to receive caffeine Active Control 1 Intervention

Group II: Group assigned to receive masked placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Kansas City Heart Rhythm Research Foundation

Lead Sponsor

Trials

30

Recruited

14,000+

Kansas City Heart Rhythm Institute, Overland Park, KS

Collaborator

Trials

3

Recruited

210+

Texas Cardiac Arrhythmia Institute, Austin, TX, USA

Collaborator

Trials

1

Recruited

100+

Loma Linda University, Loma Linda, California, USA

Collaborator

Trials

1

Recruited

100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2257921/

The effects of caffeine on the inducibility of atrial fibrillation Contrary to the prevailing views, this study suggests that intravenously administered caffeine results in a reduced propensity for AF in normal hearts and those ...

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11648991/

Caffeine and Arrhythmias: A Critical Analysis of ... Studies have shown mixed results regarding caffeine's association with arrhythmias, particularly atrial fibrillation and ventricular arrhythmias, with some ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X18300756

Caffeine and Arrhythmias: Time to Grind the Data This study provides a comprehensive review of the impact of caffeinated beverages on cardiac rhythm.

5. 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.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523019512

Caffeine consumption and incident atrial fibrillation in women Conclusions: In this large cohort of initially healthy women, elevated caffeine consumption was not associated with an increased risk of incident AF. Therefore, ...

7. jacc.org jacc.org/doi/10.1016/j.jacep.2018.01.012

Caffeine and Arrhythmias: Time to Grind the Data In a canine model, an intravenous injection of 1 to 5 mg/kg of caffeine unexpectedly reduced AF inducibility (15).