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

NCT05464940 | Not Yet Recruiting

• 1 other identifier: KCHRRF-COFFEE AF-0012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of patients with Site-specific changes in AERP(Atrial Effective Refractory Period)

  1 day

• Number of patients with Changes in conduction time

  1 day

• Number of patients with Induction of Atrial Fibrillation/Atrial Tachycardia (AF/AT) or other arrhythmias

  1 day

• Number of patients with Identification of non-pulmonary triggers of AF

  1 day

Study Arms (2)

Group assigned to receive caffeine

ACTIVE COMPARATOR

Other: Intravenous caffeine

Group assigned to receive masked placebo

PLACEBO COMPARATOR

Other: Masked Placebo

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.

Group assigned to receive caffeine

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.

Group assigned to receive masked placebo

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients will be excluded if any of the following were identified:
• History of substance abuse or alcoholism.
• Left ventricular ejection fraction \<50%.
• Liver dysfunction.
• Pregnancy.
• Inability to give informed consent.
• Amiodarone uses within 1 month prior to procedure.
• AAD use within 24 h prior to the procedure
• Severe intolerance to caffeine.

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead
• Kansas City Heart Rhythm Institute, Overland Park, KS: collaborator
• Texas Cardiac Arrhythmia Institute, Austin, TX, USA: collaborator
• Loma Linda University, Loma Linda, California, USA: collaborator

Study Sites (9)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

Location

Centerpoint Medical Center Clinic

Independence, Missouri, 64057, United States

Location

Centerpoint Medical Center

Independence, Missouri, 64057, United States

Location

Research Medical Center Clinic

Kansas City, Missouri, 64032, United States

Location

Research Medical Center

Kansas City, Missouri, 64032, United States

Location

Texas Cardiac Arrythmia Institute

Austin, Texas, 78705, United States

Location

Related Publications (9)

• 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.

  PMID: 18774047 BACKGROUND

• 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.

  PMID: 19000770 BACKGROUND

• 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.

  PMID: 19428492 BACKGROUND

• 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.

  PMID: 18809264 BACKGROUND

• 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.

  PMID: 6634380 BACKGROUND

• 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.

  PMID: 16919674 BACKGROUND

• 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.

  PMID: 31378120 BACKGROUND

• 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.

  PMID: 26394673 BACKGROUND

• 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.

  PMID: 20573799 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dhanunjaya Lakkireddy

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969; datkins@kchrf.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 19, 2022
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)