Caffeine for Atrial Fibrillation

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This "How caffeine Induces Atrial Tachyarrhythmias" trial will be a multi-center, randomized, double-blinded trial of intravenous caffeine versus placebo among patients undergoing pulmonary vein isolation procedures for Atrial Fibrillation(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 caffeine safe for humans?

Caffeine can cause heart rhythm problems, especially in high amounts, and has been linked to atrial fibrillation (a type of irregular heartbeat). It's important to be aware of these potential risks, especially if consuming large quantities. ^{1 2 3 4 5}

How does caffeine differ from other treatments for atrial fibrillation?

Caffeine is unique as a treatment for atrial fibrillation because it is a common dietary component rather than a traditional medication, and its effects on heart rhythm are not well-established. Unlike standard treatments, caffeine can both induce and potentially help convert arrhythmias, making its role in managing atrial fibrillation complex and not fully understood. ^{1 2 5 6 7}

Research Team

Dhanunjaya Lakkireddy

Principal Investigator

Kansas City Heart Rhythm Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

The effects of caffeine on the inducibility of atrial fibrillation. [2018]

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

Caffeine-related atrial fibrillation. [2013]

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

An evaluation of the change in electrocardiographic P-wave variables after acute caffeine ingestion in normal volunteers. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Does Caffeine Consumption Increase the Risk of New-Onset Atrial Fibrillation? [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Caffeine antinociception: role of formalin concentration and adenosine A1 and A2 receptors. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Electromechanical effects of caffeine in isolated human atrial fibres. [2019]