Coffee and Real-time Atrial and Ventricular Ectopy (CRAVE)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Premature Atrial Contractions; Premature Ventricular Contractions

Treatments: Behavioral: Start: On Caffeine; Behavioral: Start: Off Caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT03671759

18-25195

Details and patient eligibility

About

Atrial fibrillation (AF) and heart failure (HF) are morbid, costly, and incompletely understood diseases that have reached epidemic proportions worldwide. A dose-dependent relationship exists between premature atrial and ventricular contractions (PACs and PVCs) and development of AF and HF, respectively. Identifying and understanding the mechanisms of additional modifiable risk factors for ectopy has the potential to markedly reduce the healthcare burden of these diseases. In considering how to modify the prevalence of these ectopic beats, the investigators believe common exposures in daily life are prime candidates. Current guidelines suggest that caffeine may be an important trigger for frequent ectopy, although large population-based studies have not demonstrated an association between caffeine consumption and development of clinically significant arrhythmias. No study has employed an actual randomization intervention to assess the effects of caffeine on cardiac ectopy. Utilizing the Eureka platform, the investigators plan to utilize the N-of-1 strategy to rigorously investigate the real-time effect of caffeine intake on ectopy.

Full description

This study is designed as a N to 1 randomized trial, where each participant will be randomized to consume or abstain from coffee each day of a 14 day monitoring period. Participants will wear an automatically recording electrocardiographic monitor (ZIO® XT Patch), continuous glucose monitor (Dexcom G6), and a fitness tracker (Fitbit INSPIRE) while utilizing Eureka-a mobile application. We will compare participant self-report of caffeine consumption, glucose monitoring, fitness levels, sleep health, and heart rhythm data in order to better understand the relationship between acute caffeine consumption and heart rhythm changes. Participants will also be genotyped for caffeine metabolism-related SNPs. A total of 100 participants will be enrolled at the UCSF study site.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Are age 18 or older
2. Have a smartphone
3. Are able to use the Eureka mobile application
4. Are willing to provide a saliva sample for genetic processing
5. Drink coffee or coffee-based products at least once a year
6. Are willing to abstain from coffee, caffeinated products, or minimally caffeinated products (decaffeinated coffee) for at least 2 days when instructed

Exclusion criteria

1. Have a history of atrial fibrillation, heart failure
2. Have an ICD or pacemaker
3. Have treatment with beta blockers, non-dihydropyridine calcium channel blockers, or Vaughn-Williams class 1 or 3 antiarrhythmic medications
4. Have a medical reason to avoid coffee

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Experimental: N-of-1

Experimental group

Description:

Participants will be randomized in two-day blocks to consume then avoid caffeine ("Start: On Caffeine") or avoid then consume caffeine ("Start: Off Caffeine"). Using an N-of-1 strategy delivered by the NIH-funded, UCSF-run Eureka platform utilizing a mobile smartphone-based application, participants will receive instructions and answer questions to help us understand the relationship between caffeine and heart rhythm.

Treatment:

Behavioral: Start: Off Caffeine

Behavioral: Start: On Caffeine

Sponsor of this trial

Lead Sponsor

University of California San Francisco (UCSF)