Atrial Fibrillation
Conditions
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).
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.
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.
Sponsors
Kansas City Heart Rhythm Institute, Overland Park, KS
Texas Cardiac Arrhythmia Institute, Austin, TX, USA
Loma Linda University, Loma Linda, California, USA
Kansas City Heart Rhythm Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The COFFEE-AF (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 AF.
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
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. AAD use within 24 h prior to the procedure 8. Severe intolerance to caffeine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Atrial Fibrillation Induction | 1 day | Induction of Atrial fibrillation will be attempted by pacing and isoproterenol infusion following study drug infusion. The ability to induce atrial fibrillation (yes or no) will be recorded as the primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Site-specific changes in AERP(Atrial Effective Refractory Period) | 1 day | It helps assess changes in AERP in milli-seconds at different potential trigger points of Atrial fibrillation during the procedure. |
| Number of patients with Changes in conduction time | 1 day | Changes in conduction time is the changes in conduction of electrical impulses with caffeine during the procedure. |
| Number of patients with Induction of Atrial Fibrillation/Atrial Tachycardia (AF/AT) or other arrhythmias | 1 day | By infusing caffeine, intraprocedural for stimulation and detection of potential triggers of ablation, will caffeine infusion lead to the start of atrial fibrillation (AF), atrial tachycardia(AT) or any other arrhythmias. |
| Number of patients with Identification of non-pulmonary triggers of AF | 1 day | Identification of non-pulmonary triggers of AF |
Countries
United States
Contacts
Primary ContactDonita Atkins
Outcome results
None listed