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NCT Number: NCT05464940

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

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).

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University, Loma Linda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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

Treatment and study plan

Intravenous caffeine

Other

Group assigned to receive caffeine will receive intravenous(IV) caffeine and sodium benzoate infusion starting at 250-500 mg.

This method will use an automated algorithm that adjusts the flow of the infusion depending on the individual's sex and weight and then in a serial fashion in response to blood caffeine measurements. Serial blood caffeine measurements at pre-determined intervals according to the algorithm will be until a steady state is obtained.

Masked Placebo

Other

The patients assigned to the masked placebo will receive 5% dextrose in 0.45% saline using the same infusion protocol for a random length of time that was within 1 standard deviation(SD) of the mean time to achieve a steady state using the caffeine protocol (17+4 min).

To maintain blinding, caffeine blood concentration measurements that will be randomly generated within 2 SDs of the predicted values calculated by the algorithm will be used and verbally communicated for placebo infusions.

Primary outcomes

  1. Number of Participants With Atrial Fibrillation Induction

    Time frame: 1 day

    Induction of Atrial fibrillation will be attempted by pacing and isoproterenol infusion following study drug infusion. The ability to induce atrial fibrillation (yes or no) will be recorded as the primary outcome.

Secondary outcomes

  1. Number of patients with Site-specific changes in AERP(Atrial Effective Refractory Period)

    Time frame: 1 day

    It helps assess changes in AERP in milli-seconds at different potential trigger points of Atrial fibrillation during the procedure.

  2. Number of patients with Changes in conduction time

    Time frame: 1 day

    Changes in conduction time is the changes in conduction of electrical impulses with caffeine during the procedure.

  3. Number of patients with Induction of Atrial Fibrillation/Atrial Tachycardia (AF/AT) or other arrhythmias

    Time frame: 1 day

    By infusing caffeine, intraprocedural for stimulation and detection of potential triggers of ablation, will caffeine infusion lead to the start of atrial fibrillation (AF), atrial tachycardia(AT) or any other arrhythmias.

  4. Number of patients with Identification of non-pulmonary triggers of AF

    Time frame: 1 day

    Identification of non-pulmonary triggers of AF

Study contacts

Contact information is provided by the study sponsor or research team.

Donita Atkins

CONTACT

[email protected]

816-651-1969

Sponsors and collaborators

Lead sponsor

Kansas City Heart Rhythm Research Foundation

Other

Collaborators

  • Kansas City Heart Rhythm Institute
  • Loma Linda University
  • Texas Cardiac Arrhythmia Institute, Austin, TX, USA

Registry information

Official study title

Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction in Patients With Paroxysmal Atrial Fibrillation: The COFFEE-AF Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2022
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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