Coffee and Real-time Atrial and Ventricular Ectopy (CRAVE)
Primary Purpose
Premature Atrial Contractions, Premature Ventricular Contractions
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Start: On Caffeine
Start: Off Caffeine
Sponsored by
About this trial
This is an interventional other trial for Premature Atrial Contractions focused on measuring Caffeine, Coffee, Arrhythmias, Palpitations, Cardiac ectopy, PACs, PVCs
Eligibility Criteria
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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: N-of-1
Arm 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.
Outcomes
Primary Outcome Measures
Change in PAC frequency
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
Change in SVT episodes
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
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
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
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
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
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.
Full Information
NCT ID
NCT03671759
First Posted
September 12, 2018
Last Updated
October 5, 2022
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03671759
Brief Title
Coffee and Real-time Atrial and Ventricular Ectopy
Acronym
CRAVE
Official Title
Coffee and Real-time Atrial and Ventricular Ectopy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Atrial Contractions, Premature Ventricular Contractions
Keywords
Caffeine, Coffee, Arrhythmias, Palpitations, Cardiac ectopy, PACs, PVCs
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: N-of-1
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Start: On Caffeine
Intervention Description
In this two-day block, participants will be instructed to consume caffeine for one day and avoid caffeine the next day.
Intervention Type
Behavioral
Intervention Name(s)
Start: Off Caffeine
Intervention Description
In this two-day block, participants will be instructed to avoid caffeine for one day and consume caffeine the next day.
Primary Outcome Measure Information:
Title
Change in PAC frequency
Description
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.
Time Frame
Baseline and after completion of coffee consumption, up to 2 weeks
Secondary Outcome Measure Information:
Title
Change in SVT episodes
Description
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.
Time Frame
Baseline and after completion of coffee consumption, up to 2 weeks
Title
Change in VT episodes
Description
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.
Time Frame
Baseline and after completion of coffee consumption, up to 2 weeks
Title
Mean daily glucose levels
Description
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.
Time Frame
2 weeks
Title
Mean step count
Description
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.
Time Frame
2 weeks
Title
Mean sleep duration
Description
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.
Time Frame
2 weeks
Title
Change in PVC frequency
Description
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.
Time Frame
Baseline and after completion of coffee consumption, up to 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory M Marcus, MD, MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Rosenthal, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11216949
Citation
Chugh SS, Blackshear JL, Shen WK, Hammill SC, Gersh BJ. Epidemiology and natural history of atrial fibrillation: clinical implications. J Am Coll Cardiol. 2001 Feb;37(2):371-8. doi: 10.1016/s0735-1097(00)01107-4.
Results Reference
background
PubMed Identifier
16961553
Citation
Coyne KS, Paramore C, Grandy S, Mercader M, Reynolds M, Zimetbaum P. Assessing the direct costs of treating nonvalvular atrial fibrillation in the United States. Value Health. 2006 Sep-Oct;9(5):348-56. doi: 10.1111/j.1524-4733.2006.00124.x.
Results Reference
background
PubMed Identifier
22179539
Citation
Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available. Erratum In: Circulation. 2012 Jun 5;125(22):e1002.
Results Reference
background
PubMed Identifier
24297188
Citation
Dewland TA, Vittinghoff E, Mandyam MC, Heckbert SR, Siscovick DS, Stein PK, Psaty BM, Sotoodehnia N, Gottdiener JS, Marcus GM. Atrial ectopy as a predictor of incident atrial fibrillation: a cohort study. Ann Intern Med. 2013 Dec 3;159(11):721-8. doi: 10.7326/0003-4819-159-11-201312030-00004.
Results Reference
background
PubMed Identifier
26160626
Citation
Dukes JW, Dewland TA, Vittinghoff E, Mandyam MC, Heckbert SR, Siscovick DS, Stein PK, Psaty BM, Sotoodehnia N, Gottdiener JS, Marcus GM. Ventricular Ectopy as a Predictor of Heart Failure and Death. J Am Coll Cardiol. 2015 Jul 14;66(2):101-9. doi: 10.1016/j.jacc.2015.04.062.
Results Reference
background
PubMed Identifier
14563598
Citation
Blomstrom-Lundqvist C, Scheinman MM, Aliot EM, Alpert JS, Calkins H, Camm AJ, Campbell WB, Haines DE, Kuck KH, Lerman BB, Miller DD, Shaeffer CW, Stevenson WG, Tomaselli GF, Antman EM, Smith SC Jr, Alpert JS, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Hiratzka LF, Hunt SA, Jacobs AK, Russell RO Jr, Priori SG, Blanc JJ, Budaj A, Burgos EF, Cowie M, Deckers JW, Garcia MA, Klein WW, Lekakis J, Lindahl B, Mazzotta G, Morais JC, Oto A, Smiseth O, Trappe HJ; European Society of Cardiology Committee, NASPE-Heart Rhythm Society. ACC/AHA/ESC guidelines for the management of patients with supraventricular arrhythmias--executive summary. a report of the American college of cardiology/American heart association task force on practice guidelines and the European society of cardiology committee for practice guidelines (writing committee to develop guidelines for the management of patients with supraventricular arrhythmias) developed in collaboration with NASPE-Heart Rhythm Society. J Am Coll Cardiol. 2003 Oct 15;42(8):1493-531. doi: 10.1016/j.jacc.2003.08.013. No abstract available.
Results Reference
background
PubMed Identifier
26813889
Citation
Dixit S, Stein PK, Dewland TA, Dukes JW, Vittinghoff E, Heckbert SR, Marcus GM. Consumption of Caffeinated Products and Cardiac Ectopy. J Am Heart Assoc. 2016 Jan 26;5(1):e002503. doi: 10.1161/JAHA.115.002503.
Results Reference
background
Links:
URL
http://emedicine.medscape.com/article/158939-treatment-a1130
Description
Ventricular Premature Complexes Treatment & Management
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Coffee and Real-time Atrial and Ventricular Ectopy
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