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NOT YET RECRUITING
NCT05464940
NA

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

Sponsor: Kansas City Heart Rhythm Research Foundation

View on ClinicalTrials.gov

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

Interventions

OTHER

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.

OTHER

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