HypertensionNCT07880704
Cardiovascular Impacts of E-cigarettes Among Older Adults
A study testing Nicotine E-cigarette and Tobacco Cigarette in people with Hypertension and Tobacco Cigarette Smoking, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This study will compare the cardiovascular effects of continued smoking with those of e-cigarette (EC) use among older adults with hypertension. Using both laboratory and real-world measurements, this study will be the first to examine the relative cardiovascular impacts of smoking and EC in a patient population at… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypertension, Tobacco Cigarette Smoking, Electronic Cigarettes
- What is being tested?
- Nicotine E-cigarette and Tobacco Cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jul 2028
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 years or older.
- Currently smokes 5 or more combustible tobacco cigarettes per day and has smoked at this level for at least 1 year, based on self-report.
- Expired-air carbon monoxide level ≥8 parts per million (ppm), confirming recent cigarette smoking.
- Average screening/baseline systolic blood pressure ≥130 mm Hg or average screening diastolic blood pressure ≥80 mm Hg.
- Able and willing to provide informed consent and complete the study procedures, including in-person visits, two 14-day study periods, daily check-ins, and use of study equipment.
- If able to become pregnant (confirmed with participant), agree to avoid pregnancy during the study.
Who cannot join
- Self-reported consumption of 4 or more standard alcoholic drinks for women or 5 or more for men on any single day during the past 30 days.
- Self-reported daily nonmedical use of opioids, stimulants, sedatives, cannabis, or another substance.
- Currently seeking or receiving smoking-cessation treatment.
- Currently uses another tobacco or nicotine product (e.g., electronic cigarettes or smokeless tobacco) on 2 or more consecutive days during the past month.
- Currently taking medication for the treatment of hypertension.
- Experienced a major medical event, including a cardiovascular event, within the past 6 months, such as myocardial infarction or acute coronary syndrome, stroke or transient ischemic attack, coronary or peripheral revascularization, hospitalization for heart failure.
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- A current unstable cardiovascular condition that, in the judgment of the PI or designated medical clinician, would make participation unsafe.
- Confirmed severe hypertension at screening: resting systolic blood pressure greater than 180 mm Hg OR diastolic blood pressure greater than 120 mm Hg on repeat assessment.
- Pregnancy, as indicated by a positive screening urine pregnancy test conducted for a participant who reports being able to become pregnant.
- The investigator or medical monitor determines that participation would present an unacceptable medical or safety risk (i.e., current concerning cardiovascular or neurologic symptoms; an acute or uncontrolled medical illness; clinically significant intoxication or withdrawal; a medication or health change likely to make blood pressure, heart rate, or study participation unsafe; inability to safely use the study equipment despite training; or another specific condition that creates a foreseeable risk from continued smoking, e-cigarette exposure, or study procedures)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kahlert Institute for Addiction Medicine
Baltimore, Maryland, 21201
Kelly Dunn, PhD, (410) 706-5260, kelly.dunn@som.umaryland.edu
About this study
Official title: Comparison of Cigarette Smoking and E-cigarette Use
This study will compare the cardiovascular effects of continued smoking with those of e-cigarette (EC) use among older adults with hypertension. Using both laboratory and real-world measurements, this study will be the first to examine the relative cardiovascular impacts of smoking and EC in a patient population at high risk of smoking-related disease progression.
Read the detailed description
Tobacco smoking remains a leading cause of chronic disease, premature death, and healthcare costs in the United States. Older adults bear the greatest burden of smoking-related cardiovascular disease (CVD), which is the leading cause of smoking-related mortality. Yet this age group remains significantly underrepresented in tobacco research and is also the only age group not experiencing a decline in smoking prevalence. Hypertension, a key factor connecting smoking to myocardial infarction, stroke, and heart failure, is especially common among older adults who smoke. Although e-cigarettes (ECs) deliver nicotine without combustion and may expose users to fewer harmful toxicants, there is limited evidence on their cardiovascular effects in older adults with pre-existing, smoking-related disease. This R03 project directly addresses a high-priority research area by directly examining the comparative effects of smoking and EC use in humans. The study will employ a rigorous, randomized within-subject crossover design to compare cigarette smoking and exclusive EC use among 30 adults aged 50 and older with hypertension. Participants will complete two 14-day phases: (1) continued smoking and (2) use of an authorized EC product. Aim 1 will evaluate changes in laboratory-based cardiovascular health measures, including resting blood pressure and heart rate, across both conditions. Aim 2 will assess changes in real-world cardiovascular function through remote measurements of blood pressure, heart rate, heart rate variability, and heart rate per step-a novel composite indicator of cardiovascular efficiency. The findings from this study will clarify short-term mechanistic effects of EC switching on cardiovascular health and identify which outcomes and measurement methods are most sensitive to change. This work will provide the first prospective evidence linking laboratory and real-world measures of cardiovascular function in older adults with smoking-related disease, thereby enhancing understanding of the health impacts of EC in populations at the greatest risk for CVD.
- Being tested
- Nicotine E-cigarette, Tobacco Cigarette
- Keywords
- e-cigarette, electronic cigarette, tobaccco smoking, hypertension, cardiovascular
- Medical subject headings
- Hypertension, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine E-cigaretteOther
E-cigarettes that are FDA-authorized will be provided to participants in their preferred flavor (tobacco or menthol) and strength.
Tobacco CigaretteOther
Participants own brand cigarette
| Study group | Role | What they receive |
|---|---|---|
| Smoking as usual | Experimental | Participants will smoke their usual cigarettes Receives: Other: Tobacco Cigarette |
| Nicotine E-cigarette | Experimental | Participants will be incentivized through payment to completely switch to an e-cigarette Receives: Other: Nicotine E-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate (laboratory)
Resting heart rate, in beats per minute, will be measured in the research laboratory. Averaged readings will be used.
Measured: Session 1 (baseline), Session 2 after 14 days of product use (smoked cigarettes or e-cigarettes counterbalanced), Session 3 after 14 additional days of product use (smoked cigarettes or e-cigarettes counterbalanced)
Blood Pressure (laboratory)
Blood pressure, in mmHg, will be measured in the laboratory (systolic and diastolic). Averaged readings will be used.
Measured: Session 1 (baseline), Session 2 after 14 days of product use (smoked cigarettes or e-cigarettes counterbalanced), Session 3 after 14 additional days of product use (smoked cigarettes or e-cigarettes counterbalanced)
Blood Pressure (remote monitoring)
Averaged at-home blood pressure readings (systolic and diastolic)
Measured: Collected daily during each of two 14-day product-use periods: one involving cigarette smoking and the other involving e-cigarette use.
Daily Resting Heart Rate (remote monitoring)
Daily average derived from wrist-worn wearable activity tracker. Calculated by dividing daily average heart rate, measured in beats per minute, by the total daily step count recorded by a study-provided wearable device.
Measured: Collected continuously across 14 days for each condition (smoking and e-cigarette)
Daily Heart Rate Variability (remote monitoring)
Daily average derived from wrist-worn wearable activity tracker
Measured: Collected continuously across 14 days for each condition (smoking and e-cigarette)
Daily Heart Rate per Step
Daily resting heart rate, in beats per minute, will be obtained using a study-provided wearable device. Repeated daily measurements will be compared within participants between the cigarette-smoking and e-cigarette periods.
Measured: Daily throughout each of two 14-day product-use periods, approximately study Days 1-28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover study in which each participant completes two 14-day conditions: smoking their usual cigarettes and receiving an e-cigarette with incentives to switch from cigarettes. The order of the conditions is counterbalanced across participants.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Bethea A Kleykamp, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880704
- Sponsor's protocol ID
- HP-00120234
- Other IDs
- R03HL188068
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to ensure confidentiality. Study results will be shared through aggregate data tables, study protocols, and peer-reviewed journal publications.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cigarette Smoking and E-cigarette Use
- ClinicalTrials.gov ID
- NCT07880704
- Acronym / sponsor ID
- HP-00120234
- Keywords
- e-cigarette, electronic cigarette, tobaccco smoking, hypertension, cardiovascular
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the cardiovascular effects of continued smoking with those of e-cigarette (EC) use among older adults with hypertension. Using both laboratory and real-world measurements, this study will be the first to examine the relative cardiovascular impacts of smoking and EC in a patient population at high risk of smoking-related disease progression.
Detailed description
Tobacco smoking remains a leading cause of chronic disease, premature death, and healthcare costs in the United States. Older adults bear the greatest burden of smoking-related cardiovascular disease (CVD), which is the leading cause of smoking-related mortality. Yet this age group remains significantly underrepresented in tobacco research and is also the only age group not experiencing a decline in smoking prevalence. Hypertension, a key factor connecting smoking to myocardial infarction, stroke, and heart failure, is especially common among older adults who smoke. Although e-cigarettes (ECs) deliver nicotine without combustion and may expose users to fewer harmful toxicants, there is limited evidence on their cardiovascular effects in older adults with pre-existing, smoking-related disease. This R03 project directly addresses a high-priority research area by directly examining the comparative effects of smoking and EC use in humans. The study will employ a rigorous, randomized within-subject crossover design to compare cigarette smoking and exclusive EC use among 30 adults aged 50 and older with hypertension. Participants will complete two 14-day phases: (1) continued smoking and (2) use of an authorized EC product. Aim 1 will evaluate changes in laboratory-based cardiovascular health measures, including resting blood pressure and heart rate, across both conditions. Aim 2 will assess changes in real-world cardiovascular function through remote measurements of blood pressure, heart rate, heart rate variability, and heart rate per step-a novel composite indicator of cardiovascular efficiency. The findings from this study will clarify short-term mechanistic effects of EC switching on cardiovascular health and identify which outcomes and measurement methods are most sensitive to change. This work will provide the first prospective evidence linking laboratory and real-world measures of cardiovascular function in older adults with smoking-related disease, thereby enhancing understanding of the health impacts of EC in populations at the greatest risk for CVD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover study in which each participant completes two 14-day conditions: smoking their usual cigarettes and receiving an e-cigarette with incentives to switch from cigarettes. The order of the conditions is counterbalanced across participants.
| Arm | Type | Receives |
|---|---|---|
| Smoking as usual | Experimental | Other: Tobacco CigaretteParticipants will smoke their usual cigarettes |
| Nicotine E-cigarette | Experimental | Other: Nicotine E-cigaretteParticipants will be incentivized through payment to completely switch to an e-cigarette |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50 years or older.
- Currently smokes 5 or more combustible tobacco cigarettes per day and has smoked at this level for at least 1 year, based on self-report.
- Expired-air carbon monoxide level ≥8 parts per million (ppm), confirming recent cigarette smoking.
- Average screening/baseline systolic blood pressure ≥130 mm Hg or average screening diastolic blood pressure ≥80 mm Hg.
- Able and willing to provide informed consent and complete the study procedures, including in-person visits, two 14-day study periods, daily check-ins, and use of study equipment.
Key exclusion criteria (10 listed)
- Self-reported consumption of 4 or more standard alcoholic drinks for women or 5 or more for men on any single day during the past 30 days.
- Self-reported daily nonmedical use of opioids, stimulants, sedatives, cannabis, or another substance.
- Currently seeking or receiving smoking-cessation treatment.
- Currently uses another tobacco or nicotine product (e.g., electronic cigarettes or smokeless tobacco) on 2 or more consecutive days during the past month.
- Currently taking medication for the treatment of hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine E-cigaretteE-cigarettes that are FDA-authorized will be provided to participants in their preferred flavor (tobacco or menthol) and strength. | Other | Nicotine E-cigarette |
| Tobacco CigaretteParticipants own brand cigarette | Other | Smoking as usual |
Primary outcome
Heart Rate (laboratory)
Time frame: Session 1 (baseline), Session 2 after 14 days of product use (smoked cigarettes or e-cigarettes counterbalanced), Session 3 after 14 additional days of product use (smoked cigarettes or e-cigarettes counterbalanced)
Resting heart rate, in beats per minute, will be measured in the research laboratory. Averaged readings will be used.
Blood Pressure (laboratory)
Time frame: Session 1 (baseline), Session 2 after 14 days of product use (smoked cigarettes or e-cigarettes counterbalanced), Session 3 after 14 additional days of product use (smoked cigarettes or e-cigarettes counterbalanced)
Blood pressure, in mmHg, will be measured in the laboratory (systolic and diastolic). Averaged readings will be used.
Blood Pressure (remote monitoring)
Time frame: Collected daily during each of two 14-day product-use periods: one involving cigarette smoking and the other involving e-cigarette use.
Averaged at-home blood pressure readings (systolic and diastolic)
Daily Resting Heart Rate (remote monitoring)
Time frame: Collected continuously across 14 days for each condition (smoking and e-cigarette)
Daily average derived from wrist-worn wearable activity tracker. Calculated by dividing daily average heart rate, measured in beats per minute, by the total daily step count recorded by a study-provided wearable device.
Daily Heart Rate Variability (remote monitoring)
Time frame: Collected continuously across 14 days for each condition (smoking and e-cigarette)
Daily average derived from wrist-worn wearable activity tracker
Daily Heart Rate per Step
Time frame: Daily throughout each of two 14-day product-use periods, approximately study Days 1-28.
Daily resting heart rate, in beats per minute, will be obtained using a study-provided wearable device. Repeated daily measurements will be compared within participants between the cigarette-smoking and e-cigarette periods.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to ensure confidentiality. Study results will be shared through aggregate data tables, study protocols, and peer-reviewed journal publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine E-cigarette and Tobacco Cigarette in people with Hypertension and Tobacco Cigarette Smoking, run by University of Maryland, Baltimore at 1 site in United States.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 19 Oct 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 States. 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?
Contact Bethea A Kleykamp, PhD (410-645-0483, bkleykamp@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (laboratory) (time frame: Session 1 (baseline), Session 2 after 14 days of product use (smoked cigarettes or e-cigarettes counterbalanced), Session 3 after 14 additional days of product use (smoked cigarettes or e-cigarettes counterbalanced)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.