Clinical trial NCT05121519: Does Eliminating Coffee Avoid Fibrillation?
Official title: A Randomized Controlled Trial to Assess Abstinence of Coffee Compared to Continued Consumption on Recurrent Atrial Fibrillation Following Cardioversion
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Coffee
Keywords: atrial fibrillation
coffee
afib
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
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
timeFrame: 6 months
Secondary outcomes:
measure: Adverse events
timeFrame: 6 months
measure: Recurrent atrial flutter or AF separately
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Parnassus
state: California
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
Study officials:
affiliation: University of California, San Francisco
name: Gregory M Marcus, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Adelaide
name: Christopher X Wong, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Christopher C Cheung, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: