Active — Not RecruitingNot Applicable

Exploring the Long-term Cardiovascular Effects of Vaping

United Kingdom172 participantsStarted 2023-04-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brachial artery FMD using ultrasound

Timeframe: 24 months

Trial details

NCT IDNCT05757934

SponsorSheffield Hallam University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Cardiovascular Diseases trials