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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Kansas City Heart Rhythm Research Foundation
Study ID
NCT05464940
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Sep 30, 2025
Status verified
Oct 2024
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Group assigned to receive caffeine
  • Placebo Comparator: Group assigned to receive masked placebo

Primary Outcome Measure

Number of Participants With Atrial Fibrillation Induction [ Time Frame: 1 day ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Loma Linda UniversityLoma LindaCalifornia92350
Jalaj Garg
Kansas City Heart Rhythm InstituteOverland ParkKansas66211
Donita Atkins
Menorah Medical CenterOverland ParkKansas66209
Donita Atkins
Overland Park Regional Medical CenterOverland ParkKansas66215
Donita Atkins
Centerpoint Medical CenterIndependenceMissouri64057
Donita Atkins
Centerpoint Medical Center ClinicIndependenceMissouri64057
Donita Atkins
Research Medical CenterKansas CityMissouri64032
Donita Atkins
Research Medical Center ClinicKansas CityMissouri64032
Donita Atkins
Texas Cardiac Arrythmia InstituteAustinTexas78705
Andrea Natale

Find similar trials in Loma Linda, CA

By condition
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By specialty
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Loma Linda University· Loma Linda, CAKansas City Heart Rhythm Institute· Overland Park, KSMenorah Medical Center· Overland Park, KSOverland Park Regional Medical Center· Overland Park, KSCenterpoint Medical Center· Independence, MOCenterpoint Medical Center Clinic· Independence, MO

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