An interventional study of Nicotine E-cigarette and Tobacco Cigarette in Hypertension, Tobacco Cigarette Smoking and Electronic Cigarettes, sponsored by University of Maryland, Baltimore. Not yet recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Basic science
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.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's planned enrollment of 40 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Maryland, Baltimore is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 63 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Self-reported daily nonmedical use of opioids, stimulants, sedatives, cannabis, or another substance.
Participants will smoke their usual cigarettes
Other: Tobacco Cigarette
Participants will be incentivized through payment to completely switch to an e-cigarette
Other: Nicotine E-cigarette
E-cigarettes that are FDA-authorized will be provided to participants in their preferred flavor (tobacco or menthol) and strength.
Participants own brand cigarette
Heart Rate (laboratory)
Resting heart rate, in beats per minute, will be measured in the research laboratory. Averaged readings will be used.
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 (laboratory)
Blood pressure, in mmHg, will be measured in the laboratory (systolic and diastolic). Averaged readings will be used.
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 (remote monitoring)
Averaged at-home blood pressure readings (systolic and diastolic)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Daily throughout each of two 14-day product-use periods, approximately study Days 1-28.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2028, 17 months later.
Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 17 months is below that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore →