A Study of Caffeine on Cardiac Arrhythmias (CACOA-HEART)
|ClinicalTrials.gov Identifier: NCT02095405|
Recruitment Status : Completed
First Posted : March 24, 2014
Last Update Posted : December 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Supraventricular Tachycardia (SVT) Atrial Fibrillation||Drug: Caffeine Other: Placebo||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Caffeine arm
SVT group: Caffeine tablets, 5 mg/kg.
AF group: Caffeinated substances and Dark Chocolate
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
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.
- 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: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095405
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator:||Robert Lemery||Ottawa Heart Institute Research Corporation|