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Trial record 15 of 77 for:    coffee

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

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ClinicalTrials.gov Identifier: NCT03671759
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Gregory Marcus, 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.

Condition or disease Intervention/treatment Phase
Premature Atrial Contractions Premature Ventricular Contractions Behavioral: Start: On Caffeine Behavioral: Start: Off Caffeine Not Applicable

Detailed Description:
For two weeks, participants will be asked to wear a continuously recording heart monitor and utilize the Eureka mobile application. On the Eureka app, participants will be able to track caffeine consumption and answer questions about mood and sleep. Participants will also receive their randomization assignment through Eureka. Participants will be asked to modify caffeine intake habits in two-day blocks; these assignments are either a) to consume caffeine for one day, then avoid caffeine the next day, or b) to avoid caffeine for one day, then consume caffeine the next day. Participants will also be given a wrist-worn fitness device (Fitbit), to track sleep, step counts, and heart rate data.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Coffee and Real-time Atrial and Ventricular Ectopy
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Change in cardiac ectopy burden [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to read and write in English
  • Has a smartphone
  • Is willing to receive message reminders from study
  • Drinks caffeinated coffee or espresso drinks
  • Is willing to abstain from caffeinated products when instructed
  • Is willing to provide saliva sample for analysis of genetic variants related to caffeine metabolism

Exclusion Criteria:

  • Is taking an anti-arrhythmic, beta-blocker, or calcium channel blocker
  • Has a pacemaker or ICD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671759


Contacts
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Contact: Christina Fang 4154764999 christina.fang@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Gregory M Marcus, MD, MAS University of California, San Francisco
Principal Investigator: David Rosenthal, MD University of California, San Francisco

Additional Information:
Publications:
Blomström-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. Review.

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Responsible Party: Gregory Marcus, Director of Clinical Research for the UCSF Division of Cardiology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03671759     History of Changes
Other Study ID Numbers: 18-25195
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gregory Marcus, University of California, San Francisco:
Caffeine
Coffee
Arrhythmias
Palpitations
Cardiac ectopy
PACs
PVCs

Additional relevant MeSH terms:
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Premature Birth
Ventricular Premature Complexes
Atrial Premature Complexes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents