Coffee and Real-time Atrial and Ventricular Ectopy

Not Applicable

Completed

• Conditions: Premature Atrial Contractions; Premature Ventricular Contractions

• Registration Number: NCT03671759
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Study Start: 2019-05-01
• Primary Completion: 2020-03-25
• Study Completion: 2020-03-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 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.
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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States