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Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction
Sponsor: Kansas City Heart Rhythm Research Foundation
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).
Official title: Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction in Patients With Paroxysmal Atrial Fibrillation: The COFFEE-AF Trial
Key Details
Gender
All
Age Range
21 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-09
Completion Date
2026-06
Last Updated
2025-08-28
Healthy Volunteers
No
Conditions
Interventions
Intravenous caffeine
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
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.
Locations (9)
Loma Linda University
Loma Linda, California, United States
Menorah Medical Center
Overland Park, Kansas, United States
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
Centerpoint Medical Center Clinic
Independence, Missouri, United States
Centerpoint Medical Center
Independence, Missouri, United States
Research Medical Center Clinic
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Texas Cardiac Arrythmia Institute
Austin, Texas, United States