Does Eliminating Coffee Avoid Fibrillation?

Atrial Fibrillation Clinical Trial

— DECAF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05121519
• Other study ID #: 21-35115
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: October 20, 2025

Study information

• Verified date: October 2023
• Source: University of California, San Francisco
• Contact: Greg Marcus, MD
• Phone: 415-608-1565
• Email: greg.marcus[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 20, 2025
• Est. primary completion date: October 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coffee

Intervention

Other:
• Consume coffee
Drink coffee regularly (recommend at least 1 cup of coffee per day)
• Avoid coffee
Abstain from coffee and other caffeinated beverages

Locations

Country	Name	City	State
United States	UCSF Parnassus	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Other arrhythmia onset or recurrence	Any change in rate of other arrhythmia occurrence determined through routine clinical care will be compared	6 months