Supraventricular Tachycardia (SVT)CACOA-HEARTNCT02095405
A Study of Caffeine on Cardiac Arrhythmias
A study testing Caffeine in people with Supraventricular Tachycardia (SVT) and Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Supraventricular Tachycardia (SVT), Atrial Fibrillation
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Document cardiac arrhythmia, consisting of either:
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Caffeine, Placebo
- Keywords
- Supraventricular Tachycardia, Atrial Fibrillation, Electrophysiology Study, Programmed Electrical Stimulation
- Medical subject headings
- Tachycardia, Supraventricular, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine arm | Active comparator | SVT group: Caffeine tablets, 5 mg/kg.
AF group: Caffeinated substances and Dark Chocolate Receives: Drug: Caffeine |
| Placebo arm | Placebo comparator | SVT group: Placebo
AF group: Decaffeinated substances and White Chocolate Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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: During programmed electrical stimulation, was SVT induced, was isoproterenol required, and what was the rate of induced tachycardia.
Measured: Invasive group: Admission to Hospital for the EP study until discharge the same day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startFeb 2010
- Primary completionAug 2012
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraventricular Tachycardia (SVT)Studies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Lemery, Ottawa Heart Institute Research Corporation
- Investigators
- Robert Lemery, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095405
- Sponsor's protocol ID
- 2009403-01H
- Acronym
- CACOA-HEART
- Status last verified
- Dec 2016
- First submitted
- 18 Mar 2014
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25081280
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Placebo Controlled Randomized Study of Caffeine in Patients With Supraventricular Tachycardia Undergoing Electrophysiologic Testing.
- ClinicalTrials.gov ID
- NCT02095405
- Acronym / sponsor ID
- CACOA-HEART / 2009403-01H
- Keywords
- Supraventricular Tachycardia, Atrial Fibrillation, Electrophysiology Study, Programmed Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine arm | Active comparator | Drug: CaffeineSVT group: Caffeine tablets, 5 mg/kg. AF group: Caffeinated substances and Dark Chocolate |
| Placebo arm | Placebo comparator | Other: PlaceboSVT group: Placebo AF group: Decaffeinated substances and White Chocolate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years.
- Document cardiac arrhythmia, consisting of either:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaffeineSVT 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. | Drug | Caffeine arm |
| PlaceboSVT 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. | Other | Placebo arm |
Primary outcome
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.
1 secondary outcome
Invasive group: Tachycardia inducibility
Time frame: Invasive group: Admission to Hospital for the EP study until discharge the same day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Derived from this study: PubMed 25081280Lemery 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Lemery principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Supraventricular Tachycardia (SVT) and Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02095405, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2016.