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

Atrial Fibrillation Clinical Trial

Official title:

Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction in Patients With Paroxysmal Atrial Fibrillation: The COFFEE-AF Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05464940
• Other study ID #: KCHRRF-COFFEE AF-0012
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• 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

Country	Name	City	State
United States	Texas Cardiac Arrythmia Institute	Austin	Texas
United States	Centerpoint Medical Center	Independence	Missouri
United States	Centerpoint Medical Center Clinic	Independence	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Research Medical Center Clinic	Kansas City	Missouri
United States	Loma Linda University	Loma Linda	California
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas
United States	Menorah Medical Center	Overland Park	Kansas
United States	Overland Park Regional Medical Center	Overland Park	Kansas

Sponsors (4)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation	Kansas City Heart Rhythm Institute, Overland Park, KS, Loma Linda University, Loma Linda, California, USA, Texas Cardiac Arrhythmia Institute, Austin, TX, USA

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Atrial Fibrillation Induction	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.	1 day
Secondary	Number of patients with Site-specific changes in AERP(Atrial Effective Refractory Period)	It helps assess changes in AERP in milli-seconds at different potential trigger points of Atrial fibrillation during the procedure.	1 day
Secondary	Number of patients with Changes in conduction time	Changes in conduction time is the changes in conduction of electrical impulses with caffeine during the procedure.	1 day
Secondary	Number of patients with Induction of Atrial Fibrillation/Atrial Tachycardia (AF/AT) or other arrhythmias	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.	1 day
Secondary	Number of patients with Identification of non-pulmonary triggers of AF	Identification of non-pulmonary triggers of AF	1 day