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

The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters and Sympathetic Nerves Activity in Healthy People

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.

Study Overview

• Status: Unknown
• Conditions: Tobacco; Use, Harmful
• Intervention / Treatment: Other: Baseline; Device: e-cigarette without nicotine; Device: e-cigarette with nicotine; Device: traditional cigarette

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-097
      • Recruiting
      • Warszawski Uniwersytet Medyczny
      • Contact: Jacek Lewandowski, M.D., Ph.D.; Phone Number: +48 22 599 2828; Email: jlewandowski@wum.edu.pl
      • Contact: Paweł Dziliński, M.D.; Phone Number: +48 22 599 2828; Email: pawel.dzilinski@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic, diastolic, mean blood pressure	mm Hg	through study completion, an average of 1 year
Heart rate	beats/min	through study completion, an average of 1 year
Blood pressure variability	mm Hg	through study completion, an average of 1 year
Puls wave velocity	m/s	through study completion, an average of 1 year
Stroke Volume	ml	through study completion, an average of 1 year
Cardiac output	ml/min	through study completion, an average of 1 year
Total Peripheral Resistance	dyn*sec/cm5	through study completion, an average of 1 year
Baroreceptor reflex sensitivity	ms/mm Hg	through study completion, an average of 1 year
Muscle sympathetic nerve activity	bursts/min, bursts/100 beats/min	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Jacek Lewandowski, M.D., Ph.D., Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: tobacco; sympathetic nervous system; cardiovascular system
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: EPAPHemo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No