<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03037775</url>
  </required_header>
  <id_info>
    <org_study_id>EPAPHemo</org_study_id>
    <nct_id>NCT03037775</nct_id>
  </id_info>
  <brief_title>The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters</brief_title>
  <acronym>EPAPHemo</acronym>
  <official_title>The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters and Sympathetic Nerves Activity in Healthy People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is intended to examine 50 healthy volunteers aged 18 - 60 years. 12-hour abstinence from&#xD;
      tobacco smoke, alcohol or coffee before the experiment will be required. The exclusion&#xD;
      criteria are medical history of stroke, coronary artery disease, chronic heart failure,&#xD;
      hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI&gt;&#xD;
      30 kg/m2), the current active disease (eg. viral infection). Test subjects will actively&#xD;
      inhale for 10 minutes tobacco or the e-cigarette smoke with nicotine fluid (18 mg/ml) or&#xD;
      fluid without nicotine for 10 minutes. The study protocol involves random allocation to&#xD;
      groups exposed to electronic or traditional cigarette smoke in cross-over scheme. The primary&#xD;
      endpoint is the maximum change in heart rate compared to mean values prior to exposure.&#xD;
      Secondary end points is the maximum change in the measured parameters (hemodynamic and&#xD;
      autonomic values) compared to the average values before exposure. The measurements will be&#xD;
      performed using the Task Force Monitor system for non-invasive measurement of hemodynamic&#xD;
      parameters and the assessment of autonomic function. Adrenergic activity will be tested with&#xD;
      microneurography. A periodic analysis is planned after examining 15 and 35 patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>RR intervals in ms, very low frequency (VLF), low frequency (LF), and high frequency (HF) components - ms2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic, diastolic, mean blood pressure</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>mm Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>beats/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure variability</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>mm Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Puls wave velocity</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>m/s</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Volume</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac output</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>ml/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Peripheral Resistance</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>dyn*sec/cm5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baroreceptor reflex sensitivity</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>ms/mm Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle sympathetic nerve activity</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>bursts/min, bursts/100 beats/min</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Tobacco; Use, Harmful</condition>
  <arm_group>
    <arm_group_label>Investigated group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Baseline</intervention_name>
    <description>measurement of baseline hemodynamic parameters</description>
    <arm_group_label>Investigated group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>e-cigarette without nicotine</intervention_name>
    <description>measurement hemodynamic parameters during smoking e-cigarette without nicotine</description>
    <arm_group_label>Investigated group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>e-cigarette with nicotine</intervention_name>
    <description>measurement hemodynamic parameters smoking e-cigarette with nicotine</description>
    <arm_group_label>Investigated group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>traditional cigarette</intervention_name>
    <description>measurement hemodynamic parameters smoking traditional cigarette</description>
    <arm_group_label>Investigated group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers aged 18 - 60 years&#xD;
&#xD;
          -  12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be&#xD;
             required&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of stroke, coronary artery disease, chronic heart failure, hypertension,&#xD;
             peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI&gt; 30&#xD;
             kg/m2), the current active disease (eg. viral infection).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacek Lewandowski, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paweł Dziliński, M.D.</last_name>
    <phone>48 22 599 2828</phone>
    <email>pawel.dzilinski@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jacek Lewandowski, M.D., Ph.D.</last_name>
    <phone>48 22 599 2828</phone>
    <email>jlewandowski@wum.edu.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Warszawski Uniwersytet Medyczny</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>02-097</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacek Lewandowski, M.D., Ph.D.</last_name>
      <phone>22 599 2828</phone>
      <phone_ext>+48</phone_ext>
      <email>jlewandowski@wum.edu.pl</email>
    </contact>
    <contact_backup>
      <last_name>Paweł Dziliński, M.D.</last_name>
      <phone>22 599 2828</phone>
      <phone_ext>+48</phone_ext>
      <email>pawel.dzilinski@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Jacek Lewandowski</investigator_full_name>
    <investigator_title>M.D., Ph.D.</investigator_title>
  </responsible_party>
  <keyword>tobacco</keyword>
  <keyword>cardiovascular system</keyword>
  <keyword>sympathetic nervous system</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03037775
org study id: EPAPHemo
nct id: NCT03037775
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Heart rate variability
time frame: through study completion, an average of 1 year
description: RR intervals in ms, very low frequency (VLF), low frequency (LF), and high frequency (HF) components - ms2
measure: Systolic, diastolic, mean blood pressure
time frame: through study completion, an average of 1 year
description: mm Hg
measure: Heart rate
time frame: through study completion, an average of 1 year
description: beats/min
measure: Blood pressure variability
time frame: through study completion, an average of 1 year
description: mm Hg
measure: Puls wave velocity
time frame: through study completion, an average of 1 year
description: m/s
measure: Stroke Volume
time frame: through study completion, an average of 1 year
description: ml
measure: Cardiac output
time frame: through study completion, an average of 1 year
description: ml/min
measure: Total Peripheral Resistance
time frame: through study completion, an average of 1 year
description: dyn*sec/cm5
measure: Baroreceptor reflex sensitivity
time frame: through study completion, an average of 1 year
description: ms/mm Hg
measure: Muscle sympathetic nerve activity
time frame: through study completion, an average of 1 year
description: bursts/min, bursts/100 beats/min
arm group label: Investigated group
arm group type: Other
description: 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
intervention type: Other
intervention name: Baseline
description: measurement of baseline hemodynamic parameters
arm group label: Investigated group
intervention type: Device
intervention name: e-cigarette without nicotine
description: measurement hemodynamic parameters during smoking e-cigarette without nicotine
arm group label: Investigated group
intervention type: Device
intervention name: e-cigarette with nicotine
description: measurement hemodynamic parameters smoking e-cigarette with nicotine
arm group label: Investigated group
intervention type: Device
intervention name: traditional cigarette
description: measurement hemodynamic parameters smoking traditional cigarette
arm group label: Investigated group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jacek Lewandowski, M.D., Ph.D.
role: Principal Investigator
affiliation: Medical University of Warsaw
last name: Paweł Dziliński, M.D.
phone: 48 22 599 2828
email: pawel.dzilinski@gmail.com
last name: Jacek Lewandowski, M.D., Ph.D.
phone: 48 22 599 2828
email: jlewandowski@wum.edu.pl
facility: 
status: Recruiting
contact: 
contact backup: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Jacek Lewandowski
investigator title: M.D., Ph.D.
mesh term: Nicotine
sharing ipd: No