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

December 20, 2016 updated by: Robert Lemery, Ottawa Heart Institute Research Corporation

A Prospective Placebo Controlled Randomized Study of Caffeine in Patients With Supraventricular Tachycardia Undergoing Electrophysiologic Testing.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Caffeine arm

SVT group: Caffeine tablets, 5 mg/kg.

AF group: Caffeinated substances and Dark Chocolate
Drug: Caffeine

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.
Placebo Comparator: Placebo arm

SVT group: Placebo

AF group: Decaffeinated substances and White Chocolate
Other: Placebo

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive group: Refractory period of the Right Ventricle (RV) and Right Atrium (RA), Non-Invasive group: Ambulatory monitoring number 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.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive group: Tachycardia inducibility
Time Frame: Invasive group: Admission to Hospital for the EP study until discharge the same day.
Invasive group: During programmed electrical stimulation, was SVT induced, was isoproterenol required, and what was the rate of induced tachycardia.
Invasive group: Admission to Hospital for the EP study until discharge the same day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Robert Lemery, Ottawa Heart Institute Research Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009403-01H

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Published article
    Information comments: DOI: 10.1111/jce.12504

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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