The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters

Tobacco; Use, Harmful Clinical Trial

— EPAPHemo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03037775
• Other study ID #: EPAPHemo
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2017
• Last updated: January 27, 2017
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Medical University of Warsaw
• Contact: Pawel Dzilinski, M.D.
• Phone: 48 22 599 2828
• Email: pawel.dzilinski[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Tobacco; Use, Harmful

Intervention

Other:
• Baseline
measurement of baseline hemodynamic parameters

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

Locations

Country	Name	City	State
Poland	Warszawski Uniwersytet Medyczny	Warszawa	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

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