Premature Atrial Contractions, Premature Ventricular Contractions
Conditions
Keywords
Caffeine, Coffee, Arrhythmias, Palpitations, Cardiac ectopy, PACs, PVCs
Brief summary
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.
Detailed 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.
Interventions
BEHAVIORALStart: On Caffeine
In this two-day block, participants will be instructed to consume caffeine for one day and avoid caffeine the next day.
BEHAVIORALStart: Off Caffeine
In this two-day block, participants will be instructed to avoid caffeine for one day and consume caffeine the next day.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PAC frequency | Baseline and after completion of coffee consumption, up to 2 weeks | Participants will be wearing a continuously recording ECG monitor for two weeks. The primary outcome will be change in premature atrial contraction (PAC) frequency due to caffeine consumption or avoidance during the enrollment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in VT episodes | Baseline and after completion of coffee consumption, up to 2 weeks | Participants will be wearing a continuously recording ECG monitor for two weeks. A secondary outcome will be change in ventricular tachycardia (VT) episodes episodes due to caffeine consumption or avoidance during the enrollment period. |
| Mean daily glucose levels | 2 weeks | Participants will be wearing a continuous glucose monitor (Dexcom G6) that will record serum glucose levels. A secondary outcome will be difference in mean daily glucose levels due to caffeine consumption or avoidance during the enrollment period. |
| Change in SVT episodes | Baseline and after completion of coffee consumption, up to 2 weeks | Participants will be wearing a continuously recording ECG monitor for two weeks. A secondary outcome will be change in supraventricular tachycardia (SVT) episodes due to caffeine consumption or avoidance during the enrollment period. |
| Mean sleep duration | 2 weeks | Participants will be wearing a fitness tracker (Fitbit INSPIRE) that will record sleep duration. A secondary outcome will be difference in mean sleep duration due to caffeine consumption or avoidance during the enrollment period. |
| Change in PVC frequency | Baseline and after completion of coffee consumption, up to 2 weeks | Participants will be wearing a continuously recording ECG monitor for two weeks. The primary outcome will be change in ventricular contraction (PVC) frequency due to caffeine consumption or avoidance during the enrollment period. |
| Mean step count | 2 weeks | Participants will be wearing a fitness tracker (Fitbit INSPIRE) that will record step counts. A secondary outcome will be difference in mean step counts due to caffeine consumption or avoidance during the enrollment period. |
Countries
United States
Outcome results
None listed