Does Eliminating Coffee Avoid Fibrillation? (DECAF)

A Pilot Randomized Controlled Trial to Assess Abstinence of Coffee Compared to Continued Consumption on Recurrent Atrial Fibrillation Following Electrical 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 pilot study will evaluate the effect of randomly assigning participants undergoing electrical cardioversion to coffee abstinence or coffee consumption over a 6 month period. This pilot 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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Coffee
• Intervention / Treatment: Other: Avoid coffee; Other: Consume coffee

Detailed Description

The purpose of this study is to assess how abstinence of coffee compared to continued consumption affects recurrent atrial fibrillation (AF) following electrical 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 electrical cardioversion will be enrolled in this study (100 per arm), and followed for up to 6 months post cardioversion. Differences in AF recurrence, symptoms, and development/recurrence of other arrhythmias will be compared between the two groups.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Greg Marcus, MD; Phone Number: 415-608-1565; Email: greg.marcus@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • UCSF Parnassus
      • Contact: Greg Marcus, MD; Phone Number: 415-608-1565; Email: greg.marcus@ucsf.edu
      • Principal Investigator: Greg Marcus, MD
      • Sub-Investigator: Christopher Wong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women ≥ 21 years of age
• Sustained 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
• Life expectancy of at least 1 year
• 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 6 months or planned in next 6 months
• Recent cardiothoracic surgery in preceding 3 months
• Cardioversion for atrial flutter rather than AF
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avoid; Patients will undergo this intervention for up to 6 months, or whenever their AF returns, whichever comes first.	Other: Avoid coffee; Abstain from coffee and other caffeinated beverages
Experimental: Consume; Patients will undergo this intervention for up to 6 months, or whenever their AF returns, whichever comes first.	Other: Consume coffee; Drink coffee regularly (recommend at least 1 cup of coffee per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Recurrent AF or AFlutter (Atrial Flutter)	The number of patient's with AF and/or AFlutter recurrence following direct current electrical cardioversion will be compared	6 months
Rate of AF or AFlutter Recurrence	The time it takes for AF and/or AFlutter recurrence to occur following direct current electrical cardioversion will be compared	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity in AF Symptoms	Any change in AF symptoms (measured through the same survey questionnaire taken at 1, 3, 6, and 12 months) following direct current electrical cardioversion will be compared. Severity of symptoms will be measured through a survey questionnaire called "AF severity" asking participants how much their AF symptoms bother them on a scale of 1 to 7, where 7 is most bothersome.	6 months
Other arrhythmia onset or recurrence	Any change in rate of other arrhythmia occurrence determined through routine clinical care will be compared	6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Greg Marcus, MD, University of California, San Francisco; Principal Investigator: Chris Wong, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Estimated): October 20, 2025
• Study Completion (Estimated): October 20, 2025

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: atrial fibrillation; coffee; afib
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 21-35115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No