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A Study of Caffeine on Cardiac Arrhythmias (CACOA-HEART)

Primary Purpose

Supraventricular Tachycardia (SVT), Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Caffeine
Placebo
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supraventricular Tachycardia (SVT) focused on measuring Supraventricular Tachycardia, Atrial Fibrillation, Electrophysiology Study, Programmed Electrical Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Sites / Locations

  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Caffeine arm

Placebo arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Invasive group: Tachycardia inducibility
Invasive group: During programmed electrical stimulation, was SVT induced, was isoproterenol required, and what was the rate of induced tachycardia.

Full Information

First Posted
March 18, 2014
Last Updated
December 20, 2016
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02095405
Brief Title
A Study of Caffeine on Cardiac Arrhythmias
Acronym
CACOA-HEART
Official Title
A Prospective Placebo Controlled Randomized Study of Caffeine in Patients With Supraventricular Tachycardia Undergoing Electrophysiologic Testing.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Caffeine is one of the most frequently consumed pharmacologic active substances in the world. The potential effects of caffeinated beverages and chocolate on human health remains of great interest. The increased prevalence of cardiac arrhythmias in the general population has resulted in greater concern about the potential effects of caffeine on cardiac arrhythmias. Patients diagnosed with a cardiac dysrhythmia are generally informed by their physician to restrict or even abstain from caffeine, despite a lack of evidence of this causal relationship. Although there have been numerous reports published on the effects of caffeine on human health, there have been few reports on the relation between caffeinated beverages and chocolate in different subgroups of patients with previously diagnosed cardiac arrhythmias, including supraventricular tachycardia (SVT), atrial fibrillation (AF), atrial flutter, and ventricular arrhythmias. These patients frequently undergo interventional ablation procedures, and have a potential for a recurrence of their arrhythmia. A greater knowledge of the effects of caffeine in different subgroups of patients with cardiac arrhythmias is thus essential to properly guide patients and physicians in their treatment. The objective of our study is to evaluate the effects of caffeine through noninvasive and/or invasive means on patients with documented symptomatic cardiac arrhythmias. One group will consist of 80 patients with Supraventricular Tachycardia (SVT): This group will undergo Invasive testing, which will be completed in the electrophysiology laboratory prior to their ablation procedure to evaluate the electrophysiologic effects of caffeine or placebo on the human heart. This testing will include a measure of the effective refractory periods, inducibility of tachyarrhythmias, and conduction intervals during programmed electrical stimulation. The other group will consist of up to 80 patients with Atrial Fibrillation: This group will undergo non-invasive testing, consisting of two consecutive 48-hr Ambulatory monitors while they consume caffeinated or noncaffeinated products.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardia (SVT), Atrial Fibrillation
Keywords
Supraventricular Tachycardia, Atrial Fibrillation, Electrophysiology Study, Programmed Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caffeine arm
Arm Type
Active Comparator
Arm Description
SVT group: Caffeine tablets, 5 mg/kg. AF group: Caffeinated substances and Dark Chocolate
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
SVT group: Placebo AF group: Decaffeinated substances and White Chocolate
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Invasive group: Refractory period of the Right Ventricle (RV) and Right Atrium (RA), Non-Invasive group: Ambulatory monitoring number of atrial and ventricular extrasystoles
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Invasive group: Tachycardia inducibility
Description
Invasive group: During programmed electrical stimulation, was SVT induced, was isoproterenol required, and what was the rate of induced tachycardia.
Time Frame
Invasive group: Admission to Hospital for the EP study until discharge the same day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lemery
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25081280
Citation
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.
Results Reference
derived

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A Study of Caffeine on Cardiac Arrhythmias

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