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Completed

NCT Number: NCT05121519

Does Eliminating Coffee Avoid Fibrillation?

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Coffee Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Adelaide Hospital, Adelaide, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Consume coffee

Other

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

Avoid coffee

Other

Abstain from coffee and other caffeinated products

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

    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

Secondary outcomes

  1. Adverse events

    Time frame: 6 months

    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

  2. Recurrent atrial flutter or AF separately

    Time frame: 6 months

    Any change in the number and rate of recurrent atrial flutter or AF separately as incident outcomes will be compared

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

A Randomized Controlled Trial to Assess Abstinence of Coffee Compared to Continued Consumption on Recurrent Atrial Fibrillation Following Cardioversion

Acronym: DECAF

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2021
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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