- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03671759
Coffee and Real-time Atrial and Ventricular Ectopy (CRAVE)
October 5, 2022 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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In this two-day block, participants will be instructed to consume caffeine for one day and avoid caffeine the next day.
In this two-day block, participants will be instructed to avoid caffeine for one day and consume caffeine the next day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PAC frequency
Time Frame: Baseline and after completion of coffee consumption, up to 2 weeks
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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.
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Baseline and after completion of coffee consumption, up to 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in SVT episodes
Time Frame: Baseline and after completion of coffee consumption, up to 2 weeks
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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.
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Baseline and after completion of coffee consumption, up to 2 weeks
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Change in VT episodes
Time Frame: Baseline and after completion of coffee consumption, up to 2 weeks
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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.
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Baseline and after completion of coffee consumption, up to 2 weeks
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Mean daily glucose levels
Time Frame: 2 weeks
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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.
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2 weeks
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Mean step count
Time Frame: 2 weeks
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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.
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2 weeks
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Mean sleep duration
Time Frame: 2 weeks
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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.
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2 weeks
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Change in PVC frequency
Time Frame: Baseline and after completion of coffee consumption, up to 2 weeks
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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.
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Baseline and after completion of coffee consumption, up to 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gregory M Marcus, MD, MAS, University of California, San Francisco
- Principal Investigator: David Rosenthal, MD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
March 25, 2020
Study Completion (Actual)
March 25, 2020
Study Registration Dates
First Submitted
September 12, 2018
First Submitted That Met QC Criteria
September 12, 2018
First Posted (Actual)
September 14, 2018
Study Record Updates
Last Update Posted (Actual)
October 7, 2022
Last Update Submitted That Met QC Criteria
October 5, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Cardiac Complexes, Premature
- Premature Birth
- Ventricular Premature Complexes
- Atrial Premature Complexes
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Caffeine
Other Study ID Numbers
- 18-25195
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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