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Completed

NCT Number: NCT03671759

Coffee and Real-time Atrial and Ventricular Ectopy

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.

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Key information

Conditions

Premature Atrial Contractions Arrhythmias, Cardiac Atrial Premature Complexes Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Premature Ventricular Contractions Ventricular Premature Complexes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Start: On Caffeine

Behavioral

In this two-day block, participants will be instructed to consume caffeine for one day and avoid caffeine the next day.

Start: Off Caffeine

Behavioral

In this two-day block, participants will be instructed to avoid caffeine for one day and consume caffeine the next day.

Primary outcomes

  1. Change in PAC frequency

    Time frame: 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 outcomes

  1. Change in SVT episodes

    Time frame: 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.

  2. Change in VT episodes

    Time frame: 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.

  3. Mean daily glucose levels

    Time frame: 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.

  4. Mean step count

    Time frame: 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.

  5. Mean sleep duration

    Time frame: 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.

  6. Change in PVC frequency

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: CRAVE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2018
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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