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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 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.
The purpose of this study is to assess how abstinence of coffee compared to continued consumption affects recurrent atrial fibrillation (AF) following 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 cardioversion will be enrolled in this study (100 per arm), and followed for up to 6 months post cardioversion. Differences in AF recurrence and symptoms will be compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avoid | Experimental | Patients will undergo this intervention for up to 6 months, or whenever their AF or atrial flutter returns, whichever comes first. |
|
| Consume | Experimental | Patients will undergo this intervention for up to 6 months, or whenever their AF or atrial flutter returns, whichever comes first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consume coffee | Other | Drink coffee regularly (recommend at least 1 cup of caffeinated coffee or one shot of espresso per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The number and rate of AF or atrial flutter recurrence following cardioversion in the coffee abstinence group and the continued coffee group will be compared | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Any change in the number and rate of adverse events before censorship, including myocardial infarction, stroke or transient ischaemic attack, heart failure exacerbation, syncope, emergency department visit, hospitalization, and death, will be compared | 6 months |
| Recurrent atrial flutter or AF separately |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory M Marcus, MD, MAS | University of California, San Francisco | Principal Investigator |
| Christopher X Wong, MBBS, PhD | University of Adelaide | Principal Investigator |
| Christopher C Cheung, MD, MPH | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Parnassus | San Francisco | California | 94143 | United States | ||
| Royal Adelaide Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41206802 | Derived | Wong CX, Cheung CC, Montenegro G, Oo HH, Pena IJ, Tang JJ, Tu SJ, Wall G, Dewland TA, Moss JD, Gerstenfeld EP, Tseng ZH, Hsia HH, Lee RJ, Olgin JE, Vedantham V, Scheinman MM, Lee C, Sanders P, Marcus GM. Caffeinated Coffee Consumption or Abstinence to Reduce Atrial Fibrillation: The DECAF Randomized Clinical Trial. JAMA. 2026 Jan 27;335(4):317-325. doi: 10.1001/jama.2025.21056. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2025 | Jun 12, 2025 | Prot_SAP_006.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 21, 2024 | Jun 12, 2025 | ICF_007.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Avoid coffee | Other | Abstain from coffee and other caffeinated products |
|
Any change in the number and rate of recurrent atrial flutter or AF separately as incident outcomes will be compared |
| 6 months |
| Adelaide |
| Australia |
| Sunnybrook Health Science Centre | Toronto | Canada |
| D013568 |
| Pathological Conditions, Signs and Symptoms |