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Does Eliminating Coffee Avoid Fibrillation? (DECAF)

Primary Purpose

Atrial Fibrillation, Coffee

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Consume coffee

Avoid coffee

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring atrial fibrillation, coffee, afib

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

UCSF ParnassusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Avoid

Consume

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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.

Other arrhythmia onset or recurrence

Any change in rate of other arrhythmia occurrence determined through routine clinical care will be compared

Full Information

NCT ID

NCT05121519

First Posted

October 26, 2021

Last Updated

September 12, 2023

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT05121519

Brief Title

Does Eliminating Coffee Avoid Fibrillation?

Acronym

DECAF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 20, 2021 (Actual)

Primary Completion Date

October 20, 2025 (Anticipated)

Study Completion Date

October 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Coffee

Keywords

atrial fibrillation, coffee, afib

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Avoid

Arm Type

Experimental

Arm Description

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

Arm Title

Consume

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Consume coffee

Intervention Description

Drink coffee regularly (recommend at least 1 cup of coffee per day)

Intervention Type

Other

Intervention Name(s)

Avoid coffee

Intervention Description

Abstain from coffee and other caffeinated beverages

Primary Outcome Measure Information:

Title

Number of Participants with Recurrent AF or AFlutter (Atrial Flutter)

Description

The number of patient's with AF and/or AFlutter recurrence following direct current electrical cardioversion will be compared

Time Frame

6 months

Title

Rate of AF or AFlutter Recurrence

Description

The time it takes for AF and/or AFlutter recurrence to occur following direct current electrical cardioversion will be compared

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Severity in AF Symptoms

Description

Time Frame

6 months

Title

Other arrhythmia onset or recurrence

Description

Any change in rate of other arrhythmia occurrence determined through routine clinical care will be compared

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Greg Marcus, MD

Phone

415-608-1565

greg.marcus@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Greg Marcus, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chris Wong, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSF Parnassus

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Greg Marcus, MD

Phone

415-608-1565

greg.marcus@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Greg Marcus, MD

First Name & Middle Initial & Last Name & Degree

Christopher Wong, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Does Eliminating Coffee Avoid Fibrillation?

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