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The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters (EPAPHemo)

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ClinicalTrials.gov Identifier: NCT03037775
Recruitment Status : Unknown
Verified January 2017 by Jacek Lewandowski, Medical University of Warsaw.
Recruitment status was:  Recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Jacek Lewandowski, Medical University of Warsaw

Brief Summary:
It is intended to examine 50 healthy volunteers aged 18 - 60 years. 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required. The exclusion criteria are medical history of stroke, coronary artery disease, chronic heart failure, hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI> 30 kg/m2), the current active disease (eg. viral infection). Test subjects will actively inhale for 10 minutes tobacco or the e-cigarette smoke with nicotine fluid (18 mg/ml) or fluid without nicotine for 10 minutes. The study protocol involves random allocation to groups exposed to electronic or traditional cigarette smoke in cross-over scheme. The primary endpoint is the maximum change in heart rate compared to mean values prior to exposure. Secondary end points is the maximum change in the measured parameters (hemodynamic and autonomic values) compared to the average values before exposure. The measurements will be performed using the Task Force Monitor system for non-invasive measurement of hemodynamic parameters and the assessment of autonomic function. Adrenergic activity will be tested with microneurography. A periodic analysis is planned after examining 15 and 35 patients.

Condition or disease Intervention/treatment Phase
Tobacco; Use, Harmful Other: Baseline Device: e-cigarette without nicotine Device: e-cigarette with nicotine Device: traditional cigarette Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters and Sympathetic Nerves Activity in Healthy People
Study Start Date : June 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Investigated group
Subjects underwent procedures: hemodynamic indices will be measured at baseline and during 1/ e-cigarette without nicotine smoking, 2/ e-cigarette with nicotine and during 3/ traditional cigarette smoking in random order
Other: Baseline
measurement of baseline hemodynamic parameters

Device: e-cigarette without nicotine
measurement hemodynamic parameters during smoking e-cigarette without nicotine

Device: e-cigarette with nicotine
measurement hemodynamic parameters smoking e-cigarette with nicotine

Device: traditional cigarette
measurement hemodynamic parameters smoking traditional cigarette




Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: through study completion, an average of 1 year ]
    RR intervals in ms, very low frequency (VLF), low frequency (LF), and high frequency (HF) components - ms2


Secondary Outcome Measures :
  1. Systolic, diastolic, mean blood pressure [ Time Frame: through study completion, an average of 1 year ]
    mm Hg

  2. Heart rate [ Time Frame: through study completion, an average of 1 year ]
    beats/min

  3. Blood pressure variability [ Time Frame: through study completion, an average of 1 year ]
    mm Hg

  4. Puls wave velocity [ Time Frame: through study completion, an average of 1 year ]
    m/s

  5. Stroke Volume [ Time Frame: through study completion, an average of 1 year ]
    ml

  6. Cardiac output [ Time Frame: through study completion, an average of 1 year ]
    ml/min

  7. Total Peripheral Resistance [ Time Frame: through study completion, an average of 1 year ]
    dyn*sec/cm5

  8. Baroreceptor reflex sensitivity [ Time Frame: through study completion, an average of 1 year ]
    ms/mm Hg

  9. Muscle sympathetic nerve activity [ Time Frame: through study completion, an average of 1 year ]
    bursts/min, bursts/100 beats/min



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers aged 18 - 60 years
  • 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required

Exclusion Criteria:

  • history of stroke, coronary artery disease, chronic heart failure, hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI> 30 kg/m2), the current active disease (eg. viral infection).

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): NCT03037775


Contacts
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Contact: Paweł Dziliński, M.D. 48 22 599 2828 pawel.dzilinski@gmail.com
Contact: Jacek Lewandowski, M.D., Ph.D. 48 22 599 2828 jlewandowski@wum.edu.pl

Locations
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Poland
Warszawski Uniwersytet Medyczny Recruiting
Warszawa, Mazowieckie, Poland, 02-097
Contact: Jacek Lewandowski, M.D., Ph.D.    22 599 2828 ext +48    jlewandowski@wum.edu.pl   
Contact: Paweł Dziliński, M.D.    22 599 2828 ext +48    pawel.dzilinski@gmail.com   
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Jacek Lewandowski, M.D., Ph.D. Medical University of Warsaw

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Responsible Party: Jacek Lewandowski, M.D., Ph.D., Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03037775     History of Changes
Other Study ID Numbers: EPAPHemo
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jacek Lewandowski, Medical University of Warsaw:
tobacco
cardiovascular system
sympathetic nervous system

Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action