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

NCT ID: NCT05464940

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-06-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Group assigned to receive caffeine

Group Type: ACTIVE_COMPARATOR

Intravenous caffeine

Intervention Type: 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 masked placebo

Group Type: PLACEBO_COMPARATOR

Masked Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kansas City Heart Rhythm Institute, Overland Park, KS

UNKNOWN

Sponsor Role: collaborator

Texas Cardiac Arrhythmia Institute, Austin, TX, USA

UNKNOWN

Sponsor Role: collaborator

Loma Linda University, Loma Linda, California, USA

UNKNOWN

Sponsor Role: collaborator

Kansas City Heart Rhythm Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dhanunjaya Lakkireddy

Role: PRINCIPAL_INVESTIGATOR

Kansas City Heart Rhythm Institute

Locations

Loma Linda University

Loma Linda, California, United States

Menorah Medical Center

Overland Park, Kansas, United States

Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Overland Park Regional Medical Center

Overland Park, Kansas, United States

Centerpoint Medical Center Clinic

Independence, Missouri, United States

Centerpoint Medical Center

Independence, Missouri, United States

Research Medical Center Clinic

Kansas City, Missouri, United States

Research Medical Center

Kansas City, Missouri, United States

Texas Cardiac Arrythmia Institute

Austin, Texas, United States

Countries

United States

Central Contacts

Donita Atkins

Role: CONTACT

datkins@kchrf.com

816-651-1969

Facility Contacts

Jalaj Garg

Role: primary

Donita Atkins

Role: primary

Donita Atkins

Role: primary

Donita Atkins

Role: primary

Donita Atkins

Role: primary

Donita Atkins

Role: primary

Donita Atkins

Role: primary

Donita Atkins

Role: primary

Andrea Natale

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 18774047 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19000770 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19428492 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18809264 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6634380 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16919674 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31378120 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26394673 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20573799 (View on PubMed)

Other Identifiers

KCHRRF-COFFEE AF-0012

Identifier Type: -

Identifier Source: org_study_id