Clinical trial NCT05464940: Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction
Official title: Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction in Patients With Paroxysmal Atrial Fibrillation: The COFFEE-AF Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
Collaborators: name: Kansas City Heart Rhythm Institute, Overland Park, KS
name: Texas Cardiac Arrhythmia Institute, Austin, TX, USA
name: Loma Linda University, Loma Linda, California, USA
First posted: 2022-07-19
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Atrial Fibrillation Induction
timeFrame: 1 day
Secondary outcomes:
measure: Number of patients with Site-specific changes in AERP(Atrial Effective Refractory Period)
timeFrame: 1 day
measure: Number of patients with Changes in conduction time
timeFrame: 1 day
measure: Number of patients with Induction of Atrial Fibrillation/Atrial Tachycardia (AF/AT) or other arrhythmias
timeFrame: 1 day
measure: Number of patients with Identification of non-pulmonary triggers of AF
timeFrame: 1 day
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Overland Park
country: United States
facility: Menorah Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Independence
country: United States
facility: Centerpoint Medical Center Clinic
state: Missouri
city: Independence
country: United States
facility: Centerpoint Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center Clinic
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Austin
country: United States
facility: Texas Cardiac Arrythmia Institute
state: Texas
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCarthy DM, Mycyk MB, DesLauriers CA. Hospitalization for caffeine abuse is associated with abuse of other pharmaceutical products. Am J Emerg Med. 2008 Sep;26(7):799-802. doi: 10.1016/j.ajem.2007.10.018.
citation: Chen Y, Parrish TB. Caffeine's effects on cerebrovascular reactivity and coupling between cerebral blood flow and oxygen metabolism. Neuroimage. 2009 Feb 1;44(3):647-52. doi: 10.1016/j.neuroimage.2008.09.057. Epub 2008 Oct 19.
citation: Temple JL. Caffeine use in children: what we know, what we have left to learn, and why we should worry. Neurosci Biobehav Rev. 2009 Jun;33(6):793-806. doi: 10.1016/j.neubiorev.2009.01.001. Epub 2009 Jan 20.
citation: Reissig CJ, Strain EC, Griffiths RR. Caffeinated energy drinks--a growing problem. Drug Alcohol Depend. 2009 Jan 1;99(1-3):1-10. doi: 10.1016/j.drugalcdep.2008.08.001. Epub 2008 Sep 21.
citation: Wendt IR, Stephenson DG. Effects of caffeine on Ca-activated force production in skinned cardiac and skeletal muscle fibres of the rat. Pflugers Arch. 1983 Aug;398(3):210-6. doi: 10.1007/BF00657153.
citation: Rashid A, Hines M, Scherlag BJ, Yamanashi WS, Lovallo W. The effects of caffeine on the inducibility of atrial fibrillation. J Electrocardiol. 2006 Oct;39(4):421-5. doi: 10.1016/j.jelectrocard.2005.12.007. Epub 2006 Aug 21.
citation: Bodar V, Chen J, Gaziano JM, Albert C, Djousse L. Coffee Consumption and Risk of Atrial Fibrillation in the Physicians' Health Study. J Am Heart Assoc. 2019 Aug 6;8(15):e011346. doi: 10.1161/JAHA.118.011346. Epub 2019 Aug 5.
citation: Larsson SC, Drca N, Jensen-Urstad M, Wolk A. Coffee consumption is not associated with increased risk of atrial fibrillation: results from two prospective cohorts and a meta-analysis. BMC Med. 2015 Sep 23;13:207. doi: 10.1186/s12916-015-0447-8.
citation: Conen D, Chiuve SE, Everett BM, Zhang SM, Buring JE, Albert CM. Caffeine consumption and incident atrial fibrillation in women. Am J Clin Nutr. 2010 Sep;92(3):509-14. doi: 10.3945/ajcn.2010.29627. Epub 2010 Jun 23.