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NCT05464940 | NOT YET RECRUITING | Atrial Fibrillation

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

Kansas City Heart Rhythm Research Foundation

Brief Summary:

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).

Condition or disease

Atrial Fibrillation

Intervention/treatment

Intravenous caffeine

Masked Placebo

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : DOUBLE
Primary Purpose : OTHER
Official Title : Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction in Patients With Paroxysmal Atrial Fibrillation: The COFFEE-AF Trial
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2025-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction

Location Details

NCT05464940

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Loma Linda University

Loma Linda, California, United States, 92350

Not yet recruiting

United States, Kansas

Menorah Medical Center

Overland Park, Kansas, United States, 66209

Not yet recruiting

United States, Kansas

Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States, 66211

Not yet recruiting

United States, Kansas

Overland Park Regional Medical Center

Overland Park, Kansas, United States, 66215

Not yet recruiting

United States, Missouri

Centerpoint Medical Center Clinic

Independence, Missouri, United States, 64057

Not yet recruiting

United States, Missouri

Centerpoint Medical Center

Independence, Missouri, United States, 64057

Not yet recruiting

United States, Missouri

Research Medical Center Clinic

Kansas City, Missouri, United States, 64032

Not yet recruiting

United States, Missouri

Research Medical Center

Kansas City, Missouri, United States, 64032

Not yet recruiting

United States, Texas

Texas Cardiac Arrythmia Institute

Austin, Texas, United States, 78705