A Study of Caffeine on Cardiac Arrhythmias

NCT02095405 | Completed

• 1 other identifier: 2009403-01H
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Stimulants and drugs are often associated with cardiac effects. Caffeine, a therapeutic xanthine, has been described as a sympathomimetic and has shown to have stimulatory effects on the heart. Patients with symptomatic cardiac arrhythmias are generally informed by their physician to stop or significantly reduce caffeine intake. However, in spite of numerous reports that have reviewed the cardiac effects of caffeine, it remains unclear to what extent this stimulant may be detrimental, and what subgroups of patients may be most vulnerable. The investigators propose to evaluate the effects of caffeine in patients with previously diagnosed cardiac arrhythmias. The results of our report will provide important new information for physicians and patients regarding the effects of caffeine on symptomatic cardiac arrhythmias.

Conditions

Supraventricular Tachycardia (SVT); Atrial Fibrillation

Keywords

Supraventricular Tachycardia; Atrial Fibrillation; Electrophysiology Study; Programmed Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

• Invasive group: Refractory period of the Right Ventricle (RV) and Right Atrium (RA), Non-Invasive group: Ambulatory monitoring number of atrial and ventricular extrasystoles

  Invasive group: During programmed electrical stimulation, determination of the effective refractory period of the atrium and ventricle. Non-Invasive group: During Ambulatory Monitoring, determination of atrial and ventricular extrasystoles.

  Invasive group: Admission to Hospital for the EP study until discharge the same day. Non-Invasive group: From start of 2 consecutive 48 hour ambulatory monitors to their removal.

Secondary Outcomes (1)

• Invasive group: Tachycardia inducibility

  Invasive group: Admission to Hospital for the EP study until discharge the same day.

Study Arms (2)

Caffeine arm

ACTIVE COMPARATOR

SVT group: Caffeine tablets, 5 mg/kg. AF group: Caffeinated substances and Dark Chocolate

Drug: Caffeine

Placebo arm

PLACEBO COMPARATOR

SVT group: Placebo AF group: Decaffeinated substances and White Chocolate

Other: Placebo

Interventions

Caffeine DRUG

SVT group: Oral tablets of Caffeine prior to the electrophysiology study in patients with SVT. AF group: Dark chocolate and Caffeinated substances in patients with AF at the time of Ambulatory monitoring.

Caffeine arm

Placebo OTHER

SVT group: Oral tablets of placebo prior to the electrophysiology study in patients with SVT. AF group: White chocolate and Decaffeinated substances in patients with AF at the time of Ambulatory monitoring.

Placebo arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years.
• Document cardiac arrhythmia, consisting of either:
• i. Patients with SVT: Patients with documented narrow complex tachycardia on a twelve lead ECG or on ambulatory monitoring ii. Patients with AF, paroxysmal (self-terminating AF within 7 days), documented on a twelve lead ECG or on ambulatory monitoring

You may not qualify if:

• Failure to provide informed consent
• Pregnancy as determined by a pre-procedure pregnancy test, or women who are breastfeeding
• Class III or IV congestive heart failure
• Myocardial infarction within the last 6 months
• Coronary stenting or cardiac surgery within the last 6 months
• History of unstable angina
• Uncontrolled hypertension
• Intolerance to caffeinated beverages or chocolate
• Dependency on medications that may severely react with caffeine: substrate for Cytochrome P450 1A2 (CYP1A2) (tizanidine), inhibit CYP1A2 (fluvoxamine, ketoconazole, and rofecoxib), induce CYP1A2 (aminoglutethimide, carbamazepine, phenobarbital, and rifampin)
• Enrolment in another study at University of Ottawa Heart Institute (UOHI), unless approved by the Human Ethics Review Board (HREB).

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (1)

• Lemery R, Pecarskie A, Bernick J, Williams K, Wells GA. A prospective placebo controlled randomized study of caffeine in patients with supraventricular tachycardia undergoing electrophysiologic testing. J Cardiovasc Electrophysiol. 2015 Jan;26(1):1-6. doi: 10.1111/jce.12504. Epub 2014 Sep 3.

  PMID: 25081280 DERIVED

MeSH Terms

Conditions

Tachycardia, Supraventricular; Atrial Fibrillation

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Robert Lemery

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Electrophysiologist

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 24, 2014
• Study Start: February 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2015
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

CA (1)