CompletedNot Applicable

Does Eliminating Coffee Avoid Fibrillation?

United States, Australia, Canada200 participantsStarted 2021-10-20

Plain-language summary

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 study will evaluate the effect of randomly assigning participants undergoing cardioversion to coffee abstinence or coffee continuation over a 6 month period. This 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men or women ≥ 21 years of age * Sustained AF or atrial flutter (provided patient has a history of 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 for at least 6 months * Life expectancy of at least 6 months * 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 3 months or planned in next 3 months * Recent cardiothoracic surgery in preceding 3 months * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with first confirmed clinical recurrence of AF or atrial flutter, or device-detected recurrence lasting longer than 30 seconds, analyzed as a time-to-event outcome

Timeframe: 6 months

Trial details

NCT IDNCT05121519

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-05

View on ClinicalTrials.gov More Atrial Fibrillation trials