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Trial record 23 of 245 for:    "ottawa heart institute"

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

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ClinicalTrials.gov Identifier: NCT02095405
Recruitment Status : Completed
First Posted : March 24, 2014
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Robert Lemery, Ottawa Heart Institute Research Corporation

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.

Condition or disease Intervention/treatment Phase
Supraventricular Tachycardia (SVT) Atrial Fibrillation Drug: Caffeine Other: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Placebo Controlled Randomized Study of Caffeine in Patients With Supraventricular Tachycardia Undergoing Electrophysiologic Testing.
Study Start Date : February 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

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.





Primary Outcome Measures :
  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 [ 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095405


Locations
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Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Robert Lemery Ottawa Heart Institute Research Corporation

Study Data/Documents: Published article  This link exits the ClinicalTrials.gov site
DOI: 10.1111/jce.12504

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Lemery, Cardiac Electrophysiologist, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02095405     History of Changes
Other Study ID Numbers: 2009403-01H
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016

Keywords provided by Robert Lemery, Ottawa Heart Institute Research Corporation:
Supraventricular Tachycardia
Atrial Fibrillation
Electrophysiology Study
Programmed Electrical Stimulation

Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents