Does Eliminating Coffee Avoid Fibrillation?

Study Overview
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Brief Summary
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Given both the increasing population impact of atrial fibrillation (AF) and the widespread consumption of coffee in society, determining an associated benefit or risk of coffee consumption on AF is of great clinical relevance. This pilot study will evaluate the effect of randomly assigning participants undergoing electrical cardioversion to coffee abstinence or coffee consumption over a 6 month period. This pilot study will provide the first, randomized evaluation of coffee on AF outcomes and will provide important information on whether or not coffee has any effect on AF recurrence.

Detailed Description
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The purpose of this study is to assess how abstinence of coffee compared to continued consumption affects recurrent atrial fibrillation (AF) following electrical cardioversion. As one of the most consumed beverages in the world, whether coffee has any effect on health outcomes is of considerable interest to physicians, scientists, and individual consumers. While significant data exist on the potential impact of coffee on many cardiometabolic parameters, there is conflicting data on any role of coffee on AF. Most studies so far have been observational in nature, limiting how much insight there is on the role of coffee on AF. This study proposes to directly compare AF outcomes for patients with AF that abstain from coffee versus those that continue coffee consumption. A total of 200 AF patients undergoing electrical cardioversion will be enrolled in this study (100 per arm), and followed for up to 6 months post cardioversion. Differences in AF recurrence, symptoms, and development/recurrence of other arrhythmias will be compared between the two groups.

Official Title
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A Pilot Randomized Controlled Trial to Assess Abstinence of Coffee Compared to Continued Consumption on Recurrent Atrial Fibrillation Following Electrical Cardioversion

Conditions
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Atrial Fibrillation, Coffee

Intervention / Treatment
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* Other: Consume coffee
* Other: Avoid coffee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ≥ 21 years of age Sustained AF Planned/scheduled direct current electrical cardioversion Consumption greater than or equal to one cup of coffee per day sometime in the past 5 years Willing and able to comply with coffee abstinence or continuation Life expectancy of at least 1 year Willing and able to return and comply with scheduled phone follow up visits Willing and able to provide written informed consent Exclusion Criteria: Established allergy or adverse reaction to coffee Stated inability to comply with coffee abstinence or continuation AF ablation in preceding 6 months or planned in next 6 months Recent cardiothoracic surgery in preceding 3 months Cardioversion for atrial flutter rather than AF Pregnancy or desire to get pregnant within next 6 months. Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study Any other criteria, which would make the patient unsuitable to participate in this study as determined by the Principal Investigator (e.g., an uncontrolled drug and/or alcohol addiction)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avoid<br>Patients will undergo this intervention for up to 6 months, or whenever their AF returns, whichever comes first. | Other: Avoid coffee<br>* Abstain from coffee and other caffeinated beverages<br>|
| Experimental: Consume<br>Patients will undergo this intervention for up to 6 months, or whenever their AF returns, whichever comes first. | Other: Consume coffee<br>* Drink coffee regularly (recommend at least 1 cup of coffee per day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Recurrent AF or AFlutter (Atrial Flutter) | The number of patient's with AF and/or AFlutter recurrence following direct current electrical cardioversion will be compared | 6 months | 
| Rate of AF or AFlutter Recurrence | The time it takes for AF and/or AFlutter recurrence to occur following direct current electrical cardioversion will be compared | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity in AF Symptoms | Any change in AF symptoms (measured through the same survey questionnaire taken at 1, 3, 6, and 12 months) following direct current electrical cardioversion will be compared. Severity of symptoms will be measured through a survey questionnaire called AF severity asking participants how much their AF symptoms bother them on a scale of 1 to 7, where 7 is most bothersome. | 6 months | 
| Other arrhythmia onset or recurrence | Any change in rate of other arrhythmia occurrence determined through routine clinical care will be compared | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, coffee, afib