Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction

Kansas City Heart Rhythm Research Foundation

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Other: Intravenous caffeine; Other: Masked Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05464940

KCHRRF-COFFEE AF-0012

Details and patient eligibility

About

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).

Full description

The mechanism by which caffeine might change cardiac electrophysiologic properties is largely unknown. Most of the prior studies conducted have evaluated the correlation based on the premise of oral consumption. One caveat among such study designs can be underreporting or overreporting the amount of caffeine ingested. To this date, no clinical trials exist that has studied the in vivo effects of caffeine to assess the atrial refractory period and conduction velocity and its potential to cause atrial or ventricular ectopy or sustained arrythmia induction including Atrial Tachycardia(AT)/Atrial Fibrillation(AF)/Ventricular Tachycardia(VT)/Ventricular Fibrillation(VF). As it is hypothesized that decreasing the atrial refractory period can render atria more prone to fibrillation. The pulmonary veins have proven integral to AF pathophysiology, the relationship between pulmonary vein electrophysiology and lifestyle factors in particular has not previously been assessed. It is also not clear if caffeine increases the risk of AF on those patients with known AF diagnosis. To bridge this gap, a randomized controlled trial is proposed to assess the effects of intravenous caffeine on atrial activity during AF ablation procedures.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All adult patients from 21-90 years of age with new onset Paroxysmal Atrial Fibrillation presenting in sinus rhythm or AF of recent onset (the latter confirmed by sinus rhythm documented no more than 1 week prior) undergoing AF ablation will be included in the study.

Exclusion criteria

Patients will be excluded if any of the following were identified:

1. History of substance abuse or alcoholism.
2. Left ventricular ejection fraction <50%.
3. Liver dysfunction.
4. Pregnancy.
5. Inability to give informed consent.
6. Amiodarone uses within 1 month prior to procedure.
7. AAD use within 24 h prior to the procedure
8. Severe intolerance to caffeine.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Group assigned to receive caffeine

Active Comparator group

Treatment:

Other: Intravenous caffeine

Group assigned to receive masked placebo

Placebo Comparator group

Treatment:

Other: Masked Placebo