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Active Not Recruiting NCT05757934

Exploring the Long-term Cardiovascular Effects of Vaping

Conditions: Cardiovascular Diseases

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 172
Sponsor: Sheffield Hallam University

Location: Sheffield Hallam University Sheffield

Summary

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.

Eligibility Criteria

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.

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Source: ClinicalTrials.gov (NCT05757934). StuddyBuddy aggregates publicly available trial information.