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Cardiovascular DiseasesLIGERNCT05757934

Exploring the Long-term Cardiovascular Effects of Vaping

An observational study of Cardiovascular Diseases, run by Sheffield Hallam University at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
How many people
172 participants
Where
1 siteUnited Kingdom
Study dates
16 Apr 2023to 30 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Vapers conforming to specific group criteria in wider Sheffield and Leeds areas, in the U.K.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Sheffield Hallam University

    Sheffield, S10 2BP

Other trials in United Kingdom

About this study

Official title: Exploring the Long-term Cardiovascular Effects of Vaping: a Longitudinal Study

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.

Read more

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.

Keywords
vaping, macrocirculation, smoking, blood biomarkers
Medical subject headings
Cardiovascular Diseases, Vaping, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05757934
Study groupRoleWhat they receive
Group Avapers, who are ex-smokers.
Group Bvapers with no previous smoking experience.
Group Cvapers, who are dual users (i.e., those who vape and smoke).
Group Dex-smokers who don't vape.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brachial artery FMD using ultrasound

    Baseline scanning to assess resting vessel diameter will be recorded over 3 min, following a 10-min resting period. The brachial artery will be imaged at a location 3 to 7 cm above the antecubital crease to create a flow stimulus in the brachial artery. The images will be obtained with a Viamo C100 (Canon Medical Systems Europe B.V., Zoetermeer, Netherlands) unit using a 7.5MHz PSI-30BX (Canon Medical Systems Europe B.V., Zoetermeer, Netherlands) transducer. A sphygmomanometric cuff will be placed on the forearm; the cuff will be inflated at least 50 mmHg above systolic pressure to occlude artery inflow for 5 min. Recordings will commence 30s before cuff deflation and continuing for 3 min after. FMD will be expressed as a change in post-stimulus diameter evaluated as a percentage of the baseline diameter.

    Measured: 24 months

Secondary outcomes (45)

  1. Brachial artery FMD using ultrasound

    As in 24 months.

    Measured: 3 months

  2. Brachial artery FMD using ultrasound

    As in 24 months.

    Measured: 6 months

  3. Brachial artery FMD using ultrasound

    As in 24 months.

    Measured: 12 months

  4. Brachial artery FMD using ultrasound

    As in 24 months.

    Measured: 18 months

  5. Vascular assessment of biomarkers

    Venous blood samples (10 ml) will be obtained from the participants via a superficial arm vein to assess C-reactive protein, IL-12 (p70), sICAM-1, IL-8 and vWF.

    Measured: 24 months

  6. Vascular assessment of biomarkers

    Venous blood samples (10 ml) will be obtained from the participants via a superficial arm vein to assess C-reactive protein, IL-12 (p70), sICAM-1, IL-8 and vWF.

    Measured: 12 months

  7. Vascular assessment of biomarkers

    Venous blood samples (10 ml) will be obtained from the participants via a superficial arm vein to assess C-reactive protein, IL-12 (p70), sICAM-1, IL-8 and vWF.

    Measured: 6 months.

  8. Vascular assessment of biomarkers

    Venous blood samples (10 ml) will be obtained from the participants via a superficial arm vein to assess C-reactive protein, IL-12 (p70), sICAM-1, IL-8 and vWF.

    Measured: 18 months

  9. Lung function

    Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).

    Measured: 24 months

  10. Lung function

    Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).

    Measured: 6 months

  11. Lung function

    Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).

    Measured: 12 months

  12. Lung function

    Lung function including FEV1, FVC and vital capacity will be measured according to international guidelines (ATS/ERS guidelines).

    Measured: 18 months

  13. Smoking dependence

    Using Fagerström questionnaire.

    Measured: baseline

  14. Vaping dependence

    Using Vaping dependence questionnaire.

    Measured: baseline

  15. Vaping dependence

    Using Vaping dependence questionnaire.

    Measured: 6 months

  16. Vaping dependence

    Using Vaping dependence questionnaire.

    Measured: 12 months

  17. Vaping dependence

    Using Vaping dependence questionnaire.

    Measured: 18 months

  18. Vaping dependence

    Using Vaping dependence questionnaire.

    Measured: 24 months

  19. Smoking dependence

    Using Fagerström questionnaire.

    Measured: 24 months

  20. Smoking dependence

    Using Fagerström questionnaire.

    Measured: 18 months

  21. Smoking dependence

    Using Fagerström questionnaire.

    Measured: 12 months

  22. Smoking dependence

    Using Fagerström questionnaire.

    Measured: 6 months

  23. Change in CV risk profile

    Q-risk assessment

    Measured: 24 months

  24. Change in CV risk profile

    Q-risk assessment

    Measured: 18 months

  25. Change in CV risk profile

    Q-risk assessment

    Measured: 12 months

  26. Change in CV risk profile

    Q-risk assessment

    Measured: 6 months

  27. Anthropometrics

    height (m), weight (m) to calculate body mass index (BMI) as weight divided by height squared,

    Measured: baseline

  28. Anthropometrics

    height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,

    Measured: 24 months

  29. Anthropometrics

    height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,

    Measured: 18 months

  30. Anthropometrics

    height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,

    Measured: 12 months

  31. Anthropometrics

    height (cm), weight (m) to calculate body mass index (BMI) as weight divided by height squared,

    Measured: 6 months

  32. Anthropometrics

    heart rate variability (assessed as normal-to-normal (NN) intervals).

    Measured: baseline

  33. Anthropometrics

    blood pressure (mmHg).

    Measured: baseline

  34. Anthropometrics

    blood pressure (mmHg).

    Measured: 6 months

  35. Anthropometrics

    blood pressure (mmHg).

    Measured: 12 months

  36. Anthropometrics

    blood pressure (mmHg).

    Measured: 18 months

  37. Anthropometrics

    blood pressure (mmHg).

    Measured: 24 months

  38. Anthropometrics

    heart rate variability (assessed as normal-to-normal (NN) intervals).

    Measured: 24 months

  39. Anthropometrics

    heart rate variability (assessed as normal-to-normal (NN) intervals).

    Measured: 18 months

  40. Anthropometrics

    heart rate variability (assessed as normal-to-normal (NN) intervals).

    Measured: 12 months

  41. Anthropometrics

    heart rate variability (assessed as normal-to-normal (NN) intervals).

    Measured: 6 months

  42. Smoking abstinence

    For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm

    Measured: 24 months

  43. Smoking abstinence

    For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm

    Measured: 18 months

  44. Smoking abstinence

    For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm

    Measured: 12 months

  45. Smoking abstinence

    For Groups A, B and D smoking abstinence will be defined by the presence of CO < 10ppm

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2023
  2. Study start16 Apr 2023
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05757934
Sponsor's protocol ID
ER49341917
Acronym
LIGER
Status last verified
Jul 2026
First submitted
7 Feb 2023
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases, run by Sheffield Hallam University at 1 site in United Kingdom.

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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. 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 United Kingdom. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brachial artery FMD using ultrasound (time frame: 24 months). 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 NCT05757934.

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 10 Jul 2026.

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