Clinical trial NCT03037775: The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters
Official title: The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters and Sympathetic Nerves Activity in Healthy People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco; Use, Harmful
Keywords: tobacco
cardiovascular system
sympathetic nervous system
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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).

Primary outcomes:
measure: Heart rate variability
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Systolic, diastolic, mean blood pressure
timeFrame: through study completion, an average of 1 year
measure: Heart rate
timeFrame: through study completion, an average of 1 year
measure: Blood pressure variability
timeFrame: through study completion, an average of 1 year
measure: Puls wave velocity
timeFrame: through study completion, an average of 1 year
measure: Stroke Volume
timeFrame: through study completion, an average of 1 year
measure: Cardiac output
timeFrame: through study completion, an average of 1 year
measure: Total Peripheral Resistance
timeFrame: through study completion, an average of 1 year
measure: Baroreceptor reflex sensitivity
timeFrame: through study completion, an average of 1 year
measure: Muscle sympathetic nerve activity
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Warszawski Uniwersytet Medyczny
state: Mazowieckie
Study officials:
affiliation: Medical University of Warsaw
name: Jacek Lewandowski, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: