Does Eliminating Coffee Avoid Fibrillation?

NCT05121519 | Completed

• 1 other identifier: 21-35115
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Atrial Fibrillation; Coffee

Keywords

atrial fibrillation; coffee; afib

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Adverse events

  6 months

• Recurrent atrial flutter or AF separately

  6 months

Study Arms (2)

Avoid

EXPERIMENTAL

Patients will undergo this intervention for up to 6 months, or whenever their AF or atrial flutter returns, whichever comes first.

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.

Other: Consume coffee

Interventions

Consume coffee OTHER

Drink coffee regularly (recommend at least 1 cup of caffeinated coffee or one shot of espresso per day)

Consume

Avoid coffee OTHER

Abstain from coffee and other caffeinated products

Avoid

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (3)

UCSF Parnassus

San Francisco, California, 94143, United States

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

Sunnybrook Health Science Centre

Toronto, Canada

Location

Related Publications (1)

• 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. 2025 Nov 9:e2521056. doi: 10.1001/jama.2025.21056. Online ahead of print.

  PMID: 41206802 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 16, 2021
• Study Start: October 20, 2021
• Primary Completion: June 5, 2025
• Study Completion: October 20, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1); AU (1)