Not yet recruitingNot applicable

Cardiovascular Impacts of E-cigarettes Among Older Adults

Comparison of Cigarette Smoking and E-cigarette Use

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares how continued cigarette smoking and e-cigarette use affect the heart and blood vessels. It is for adults age 50 or older who smoke and have high blood pressure. Measurements will be taken in a lab and in daily life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 50 or older.
  • You report smoking at least 5 regular tobacco cigarettes a day for at least 1 year.
  • A breath test shows a carbon monoxide level of at least 8 parts per million, which confirms recent smoking.
  • Your average blood pressure at screening has a top number of at least 130 or a bottom number of at least 80.
  • You can and agree to give informed consent and complete the study. This includes in-person visits, two 14-day study periods, daily check-ins, and using study equipment.
  • If you can become pregnant, you agree to avoid pregnancy during the study.

Who can't join

  • In the past 30 days, you report having at least 4 standard alcoholic drinks in one day if you are a woman, or at least 5 if you are a man.
  • You report daily use of opioids, stimulants, sedatives, cannabis, or another substance for nonmedical reasons.
  • You are seeking or receiving treatment to quit smoking, or you used another tobacco or nicotine product on at least 2 days in a row during the past month.
  • You currently take medicine to treat high blood pressure.
  • You had a major medical event in the past 6 months. Examples include a heart attack, stroke or mini-stroke, a procedure to restore blood flow to the heart or limbs, or a hospital stay for heart failure.
  • You have an unstable heart or blood vessel condition that makes the study unsafe, or repeat resting blood pressure tests show a top number above 180 or a bottom number above 120.
  • You have a positive urine pregnancy test at screening.
  • The study doctor finds another health or safety risk. This may include concerning heart or brain symptoms, an uncontrolled illness, intoxication or withdrawal, unsafe changes in medicines or health, or trouble using study equipment safely despite training.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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)

Study sites (1)

MD