NCT03036644

Comparison of Electronic Cigarettes and Tobacco Cigarettes on Cardiovascular Function and Oxidative Stress

Completed NA Last updated 3 November 2020

What this trial tests

NA trial testing e-cigarette (PG+VG without nicotine; low temperature) in Cardiovascular Risk Factor in 25 participants. Completed in 31 December 2019.

Timeline

15 January 2017

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Université Libre de Bruxelles
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	25
Start date	15 January 2017
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across Belgium

Drugs / interventions tested

• e-cigarette (PG+VG without nicotine; low temperature)
• e-cigarette (PG+VG with nicotine; low temperature)
• e-cigarette (PG+VG without nicotine; high temperature)
• e-cigarette (PG+VG with nicotine; high temperature)
• tobacco cigarette

Conditions studied

• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →

Sponsor

Université Libre de Bruxelles — full company profile →

Who can join

Adults 18 to 60, any sex, with Cardiovascular Risk Factor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Electronic cigarettes (e-cigarettes) are battery-powered devices heating a liquid (e-liquid) composed of propylene glycol and/or vegetable glycerin, and most commonly, nicotine to form an aerosol (vapor) that is inhaled (i.e. "vaped"). Scarce and conflicting data are available regarding the cardiovascular toxicity of e-cigarettes. We wish to determine the acute effects of propylene glycol/vegetable glycerin and nicotine vaporization at high temperature in comparison to tobacco cigarette smoking on several advanced cardiovascular parameters in healthy chronic e-cigarettes users and tobacco smokers. Furthermore, a large range of plasma, urine and respiratory oxidative stress markers will be quantified. By this way, we aim to demonstrate that e-cigarettes-induced systemic oxidative stress could be linked to cardiovascular toxicity. To the best of our knowledge, this is the first project that evaluates the effects of e-cigarettes vaping in comparison to tobacco cigarette smoking on the cardiovascular system in relation to vaporization temperature, nicotine delivery and oxidative stress.

Aims of the study: This study tests the following hypotheses: 1) acute high temperature vaporization of propylene glycol and vegetable glycerin has no deleterious effects on cardiovascular parameters in comparison to tobacco smoking; 2) Tobacco smoking rises plasma and urine oxidative stress biomarkers. On the contrary, acute and chronic e-cigarettes vaping don't rise these biomarkers. At a cellular level, plasma of smokers but not vapers increases superoxide anion production.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Lindson N, Bullen C, et al · · 2020 · cited 314× · PMID 33052602 · DOI 10.1002/14651858.cd010216.pub4
2. Differential Effects of E-Cigarette on Microvascular Endothelial Function, Arterial Stiffness and Oxidative Stress: A Randomized Crossover Trial.
   Chaumont M, de Becker B, Zaher W, Culié A, et al · · 2018 · cited 149× · PMID 29991814 · DOI 10.1038/s41598-018-28723-0
3. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, Lindson N, Butler AR, McRobbie H, et al · · 2022 · cited 147× · PMID 36384212 · DOI 10.1002/14651858.cd010216.pub7
4. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Lindson N, Bullen C, et al · · 2021 · cited 126× · PMID 33913154 · DOI 10.1002/14651858.cd010216.pub5
5. Fourth generation e-cigarette vaping induces transient lung inflammation and gas exchange disturbances: results from two randomized clinical trials.
   Chaumont M, van de Borne P, Bernard A, Van Muylem A, et al · · 2019 · cited 111× · PMID 30724099 · DOI 10.1152/ajplung.00492.2018
6. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Butler AR, Lindson N, et al · · 2021 · cited 106× · PMID 34519354 · DOI 10.1002/14651858.cd010216.pub6