Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction in Patients With Paroxysmal Atrial Fibrillation: The COFFEE-AF Trial
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).
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…
Eligibility
- Age range
- 21–90 years
- Sex
- All
- Healthy volunteers
- No
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.…
Interventions
- OtherIntravenous 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.
- OtherMasked 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 UniversityLoma Linda, California
- Menorah Medical CenterOverland Park, Kansas
- Kansas City Heart Rhythm InstituteOverland Park, Kansas
- Overland Park Regional Medical CenterOverland Park, Kansas
- Centerpoint Medical Center ClinicIndependence, Missouri
- Centerpoint Medical CenterIndependence, Missouri