Atrial FibrillationDECAFNCT05121519
Does Eliminating Coffee Avoid Fibrillation?
A study testing Consume coffee and Avoid coffee in people with Atrial Fibrillation and Coffee, run by University of California, San Francisco at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation, Coffee
- What is being tested?
- Consume coffee and Avoid coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 20 Oct 2021to 20 Oct 2025
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Randomized Controlled Trial to Assess Abstinence of Coffee Compared to Continued Consumption on Recurrent Atrial Fibrillation Following 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 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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation, Coffee
- Being tested
- Consume coffee, Avoid coffee
- Keywords
- atrial fibrillation, coffee, afib
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consume coffeeOther
Drink coffee regularly (recommend at least 1 cup of caffeinated coffee or one shot of espresso per day)
Avoid coffeeOther
Abstain from coffee and other caffeinated products
| Study group | Role | What they receive |
|---|---|---|
| Avoid | Experimental | Patients will undergo this intervention for up to 6 months, or whenever their AF or atrial flutter returns, whichever comes first. Receives: Other: Avoid coffee |
| Consume | Experimental | Patients will undergo this intervention for up to 6 months, or whenever their AF or atrial flutter returns, whichever comes first. Receives: Other: Consume coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
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
Measured: 6 months
Recurrent atrial flutter or AF separately
Any change in the number and rate of recurrent atrial flutter or AF separately as incident outcomes will be compared
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start20 Oct 2021
- Primary completion5 Jun 2025
- Study completion20 Oct 2025
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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory M Marcus, MD, MAS, Principal investigator, University of California, San FranciscoChristopher X Wong, MBBS, PhD, Principal investigator, University of AdelaideChristopher C Cheung, MD, MPH, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121519
- Sponsor's protocol ID
- 21-35115
- Acronym
- DECAF
- Status last verified
- Nov 2025
- First submitted
- 26 Oct 2021
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41206802
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess Abstinence of Coffee Compared to Continued Consumption on Recurrent Atrial Fibrillation Following Cardioversion
- ClinicalTrials.gov ID
- NCT05121519
- Acronym / sponsor ID
- DECAF / 21-35115
- Conditions
- Atrial Fibrillation, Coffee
- Keywords
- atrial fibrillation, coffee, afib
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 16 Nov 2021 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avoid | Experimental | Other: Avoid coffeePatients will undergo this intervention for up to 6 months, or whenever their AF or atrial flutter returns, whichever comes first. |
| Consume | Experimental | Other: Consume coffeePatients will undergo this intervention for up to 6 months, or whenever their AF or atrial flutter returns, whichever comes first. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Consume coffeeDrink coffee regularly (recommend at least 1 cup of caffeinated coffee or one shot of espresso per day) | Other | Consume |
| Avoid coffeeAbstain from coffee and other caffeinated products | Other | Avoid |
Primary outcome
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
Time frame: 6 months
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
2 secondary outcomes
Adverse events
Time frame: 6 months
Recurrent atrial flutter or AF separately
Time frame: 6 months
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 26 Nov 2025.
- Derived from this study: PubMed 41206802Wong 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.
- Individual participant dataSharing planned: No
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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.
Gregory M Marcus, MD, MAS principal investigator
University of California, San Francisco
Christopher X Wong, MBBS, PhD principal investigator
University of Adelaide
Christopher C Cheung, MD, MPH principal investigator
Sunnybrook Health Sciences Centre
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consume coffee and Avoid coffee in people with Atrial Fibrillation and Coffee, run by University of California, San Francisco at 3 sites in 3 countries.
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 8 inclusion and 7 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia, 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. 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?
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 (time frame: 6 months). 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 NCT05121519, 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 26 Nov 2025; AzTrials last refreshed its copy on 28 Oct 2026.