Atrial Fibrillation Clinical Trial
— DECAFOfficial title:
A Pilot Randomized Controlled Trial to Assess Abstinence of Coffee Compared to Continued Consumption on Recurrent Atrial Fibrillation Following Electrical Cardioversion
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | October 20, 2025 |
Est. primary completion date | October 20, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Parnassus | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Other arrhythmia onset or recurrence | Any change in rate of other arrhythmia occurrence determined through routine clinical care will be compared | 6 months |
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