Tobacco; Use, HarmfulEPAPHemoNCT03037775
The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters
A study testing Baseline, e-cigarette without nicotine and e-cigarette with nicotine in people with Tobacco; Use, Harmful, run by Medical University of Warsaw at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco; Use, Harmful
- What is being tested?
- Baseline, e-cigarette without nicotine and e-cigarette with nicotine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers aged 18 - 60 years
- 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Warszawski Uniwersytet Medyczny
Warsaw, Masovian Voivodeship, 02-097
Jacek Lewandowski, M.D., Ph.D., 22 599 2828 ext. +48, jlewandowski@wum.edu.pl
Paweł Dziliński, M.D., 22 599 2828 ext. +48, pawel.dzilinski@gmail.com
About this study
Official title: 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.
- Conditions
- Tobacco; Use, Harmful
- Being tested
- Baseline, e-cigarette without nicotine, e-cigarette with nicotine, traditional cigarette
- Keywords
- tobacco, cardiovascular system, sympathetic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaselineOther
measurement of baseline hemodynamic parameters
e-cigarette without nicotineDevice
measurement hemodynamic parameters during smoking e-cigarette without nicotine
e-cigarette with nicotineDevice
measurement hemodynamic parameters smoking e-cigarette with nicotine
traditional cigaretteDevice
measurement hemodynamic parameters smoking traditional cigarette
| Study group | Role | What they receive |
|---|---|---|
| Investigated group | Other | 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 Receives: Other: Baseline; Device: e-cigarette without nicotine; Device: e-cigarette with nicotine; Device: traditional cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
RR intervals in ms, very low frequency (VLF), low frequency (LF), and high frequency (HF) components - ms2
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
Systolic, diastolic, mean blood pressure
mm Hg
Measured: through study completion, an average of 1 year
Heart rate
beats/min
Measured: through study completion, an average of 1 year
Blood pressure variability
mm Hg
Measured: through study completion, an average of 1 year
Puls wave velocity
m/s
Measured: through study completion, an average of 1 year
Stroke Volume
ml
Measured: through study completion, an average of 1 year
Cardiac output
ml/min
Measured: through study completion, an average of 1 year
Total Peripheral Resistance
dyn*sec/cm5
Measured: through study completion, an average of 1 year
Baroreceptor reflex sensitivity
ms/mm Hg
Measured: through study completion, an average of 1 year
Muscle sympathetic nerve activity
bursts/min, bursts/100 beats/min
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startJun 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco; Use, HarmfulStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacek Lewandowski, Medical University of Warsaw
- Investigators
- Jacek Lewandowski, M.D., Ph.D., Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037775
- Sponsor's protocol ID
- EPAPHemo
- Acronym
- EPAPHemo
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sobieraj P, Dzilinski P, Sinski M, Kujawski S, Zalewski P, Lewandowski J. Randomized crossover trial comparing short-term hemodynamic and autonomic effects of e-cigarettes with and without nicotine and conventional cigarette smoking in apparently healthy individuals. Am J Prev Cardiol. 2026 Apr 2;28:101598. doi: 10.1016/j.ajpc.2026.101598. eCollection 2026 Aug.
PubMed 42395095
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters and Sympathetic Nerves Activity in Healthy People
- ClinicalTrials.gov ID
- NCT03037775
- Acronym / sponsor ID
- EPAPHemo / EPAPHemo
- Conditions
- Tobacco; Use, Harmful
- Keywords
- tobacco, cardiovascular system, sympathetic nervous system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigated group | Other | Other: Baseline, Device: e-cigarette without nicotine, Device: e-cigarette with nicotine, Device: traditional cigaretteSubjects 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy volunteers aged 18 - 60 years
- 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baselinemeasurement of baseline hemodynamic parameters | Other | Investigated group |
| e-cigarette without nicotinemeasurement hemodynamic parameters during smoking e-cigarette without nicotine | Device | Investigated group |
| e-cigarette with nicotinemeasurement hemodynamic parameters smoking e-cigarette with nicotine | Device | Investigated group |
| traditional cigarettemeasurement hemodynamic parameters smoking traditional cigarette | Device | Investigated group |
Primary outcome
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
9 secondary outcomes
Systolic, diastolic, mean blood pressure
Time frame: through study completion, an average of 1 year
Heart rate
Time frame: through study completion, an average of 1 year
Blood pressure variability
Time frame: through study completion, an average of 1 year
Puls wave velocity
Time frame: through study completion, an average of 1 year
Stroke Volume
Time frame: through study completion, an average of 1 year
Cardiac output
Time frame: through study completion, an average of 1 year
Total Peripheral Resistance
Time frame: through study completion, an average of 1 year
Baroreceptor reflex sensitivity
Time frame: through study completion, an average of 1 year
Muscle sympathetic nerve activity
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Derived from this study: PubMed 42395095Sobieraj P, Dzilinski P, Sinski M, Kujawski S, Zalewski P, Lewandowski J. Randomized crossover trial comparing short-term hemodynamic and autonomic effects of e-cigarettes with and without nicotine and conventional cigarette smoking in apparently healthy individuals. Am J Prev Cardiol. 2026 Apr 2;28:101598. doi: 10.1016/j.ajpc.2026.101598. eCollection 2026 Aug.
- Individual participant dataSharing planned: No
Related trials for Tobacco; Use, Harmful
Recruiting
Little Cigar Oxidants
Tobacco Use, Oxidative Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacek Lewandowski, M.D., Ph.D. principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline, e-cigarette without nicotine and e-cigarette with nicotine in people with Tobacco; Use, Harmful, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paweł Dziliński, M.D. (48 22 599 2828, pawel.dzilinski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03037775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.