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Exploring the Long-term Cardiovascular Effects of Vaping (LIGER)

Sheffield Hallam University logo

Sheffield Hallam University

Status

Active, not recruiting

Conditions

Cardiovascular Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT05757934
ER49341917

Details and patient eligibility

About

Smoking is the "leading, preventable death-cause worldwide", being responsible for almost 700,000 deaths in the E.U. annually. Therefore, implementing successful, long-term smoking cessation strategies is a long-term priority for the NHS.

Recent evidence suggests that e-cigarettes (i.e., vaping) are a successful cessation tool, with around 3.6 million users in the UK. There are concerns about long-term vaping, particularly in relation to their cardiovascular effects, as there are no relevant, longitudinal studies.

Therefore, we propose a 38-month, four-group longitudinal study exploring the cardiovascular physiological effects of the use of e-cigarettes over a two-year period, informing policy makers and e-cigarette users (vapers). Our study was developed with the support of vapers.

The main research question is whether there are any differences in cardiovascular physiology between vapers, who are ex-smokers (Group A), vapers with no previous smoking experience (Group B), dual users (i.e., those who vape and smoke (Group C) and ex-smokers who don't vape (Group D).

Two-hundred participants from Sheffield and Leeds will be invited on five occasions (baseline, as well as 6-,12-,18- and 24-months post-baseline).

We will assess macrovascular and lung function, cardiovascular disease risk (through questionnaires and blood biomarkers), vaping and smoking dependence, smoking and and vaping history among others.

Enrollment

172 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Inclusion Criteria: Age ≥18 years of either gender. Specific group inclusion criteria include:

Group A: Ex-smokers with previous smoking history of at least two years, who vape for at least one year, at least 50 puffs a day.

Group B: Current vapers who have been vaping daily (minimum 50 puffs/day) for at least one year, with no previous smoking history, Group C: Current vapers (50 puffs/day), who smoke at least 20 cigarettes per week. Group D: Ex-smokers, who have stopped smoking for a period greater than one year and who currently do not vape.

Exclusion criteria

  • Non-ambulant people and people with a recent (e.g., within 6 months) CVD event (e.g. stroke, myocardial infarction) or cardiac surgery,
  • pregnancy,
  • people who require major surgery (which will prevent them of taking part in the study),
  • people who are unable or unwilling to give informed consent.

Trial design

172 participants in 4 patient groups

Group A
Description:
vapers, who are ex-smokers.
Group B
Description:
vapers with no previous smoking experience.
Group C
Description:
vapers, who are dual users (i.e., those who vape and smoke).
Group D
Description:
ex-smokers who don't vape.

Trial contacts and locations

1

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Central trial contact

Alexandros Mitropoulos, PhD; Markos Klonizakis, D.Phil.

Data sourced from clinicaltrials.gov

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