We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671759
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : October 7, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 14, 2018
Last Update Posted Date October 7, 2022
Actual Study Start Date  ICMJE May 1, 2019
Actual Primary Completion Date March 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2022)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
Ectopic beats due to caffeine exposure [ Time Frame: 2 weeks ]
Participants will be wearing a continuously recording ECG monitor for two weeks. The primary outcome will be change in ectopy burden due to caffeine consumption or avoidance during the enrollment period.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coffee and Real-time Atrial and Ventricular Ectopy
Official Title  ICMJE Coffee and Real-time Atrial and Ventricular Ectopy
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Premature Atrial Contractions
  • Premature Ventricular Contractions
Intervention  ICMJE
  • Behavioral: Start: On Caffeine
    In this two-day block, participants will be instructed to consume caffeine for one day and avoid caffeine the next day.
  • Behavioral: Start: Off Caffeine
    In this two-day block, participants will be instructed to avoid caffeine for one day and consume caffeine the next day.
Study Arms  ICMJE Experimental: Experimental: N-of-1
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.
Interventions:
  • Behavioral: Start: On Caffeine
  • Behavioral: Start: Off Caffeine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2020)
108
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2018)
80
Actual Study Completion Date  ICMJE March 25, 2020
Actual Primary Completion Date March 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03671759
Other Study ID Numbers  ICMJE 18-25195
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of California, San Francisco
Original Responsible Party Gregory Marcus, University of California, San Francisco, Director of Clinical Research for the UCSF Division of Cardiology
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregory M Marcus, MD, MAS University of California, San Francisco
Principal Investigator: David Rosenthal, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP