Losartan for Cardiovascular Health in Secondhand Smoke Exposure

This study is looking at how well an FDA-approved medicine called losartan works to improve heart and lung health in people who were exposed to a lot of secondhand tobacco smoke over a long time. You might be able to join if you are 40 or older and have a history of working in places with secondhand smoke for at least 5 years, like flight attendants before smoking bans or casino workers. The study will compare losartan (50 mg tablets) to a placebo (a tablet with no medicine) to see if it can help improve how well your heart pumps blood (Left Ventricular Ejection Fraction) and the stiffness of your arteries (Aortic pulse wave velocity). We'll also look at changes in certain immune cells over about 10 weeks.

Study design
This is a double-blind, randomized, placebo-controlled crossover study, meaning neither you nor the researchers will know if you're receiving losartan or the placebo. It plans to include 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your heart's pumping ability and artery stiffness will be measured at the start, and changes in certain immune cells will be tracked for up to 10 weeks.

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NCT04715568

Secondhand Tobacco Smoke and Cardiovascular Disease

Recruiting
PHASE4Ages 40+InterventionalTreatment
University of California, San Francisco
~100 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:LosartanPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Left Ventricular Ejection Fraction (LVEF)
Measured over Baseline, approximately 1 day
+3 more outcomes measured
Cardiovascular Diseases
Hypertension
1 sites across 1 states
California1
  • Mehrdad Arjomandi, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

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Eligibility criteria

Inclusion

Must be able to understand and provide informed consent.
Adults \>= 40 years of age.
Must have a history of occupational exposure to secondhand tobacco smoke for at least 5 years such as flight attendants who worked for airlines before the smoking ban on aircrafts went into effect or casino workers who worked at casinos with no smoke-free policies.
Must have never smoked or have a remote history of light smoking defined as follows:
Lifetime smoking history equivalent to \< 1 pack-year and
No smoking history for \>= 20 years at the time of enrollment.

Exclusion

Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
Subject is pregnant, breast-feeding, or plans to become pregnant.
Current therapy with angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
Known intolerance to ACE inhibitor or ARB.
History of angioedema.
Conventional indication for ACE inhibitor or ARB (e.g., history of myocardial infarction, known cardiomyopathy).
Blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic while standing or sitting.
Known unilateral or bilateral renal artery stenosis higher than 70%.
Renal insufficiency (Creatinine Clearance \<30 mL/min by Cockcroft-Gault calculation).
Current regular use of NSAIDs defined as daily use on 5 or more days of the week for more than one month.
Potassium supplementation or serum potassium level of 5.0 milliequivalents (mEq)/dL or higher at V1.
Current use of a potassium sparing diuretic.
History of clinically overt cardiovascular disease including: stable or unstable angina; chest discomfort and dyspnea with baseline exertion; symptomatic coronary artery disease (as defined by history of abnormal stress test; cardiac catheterization showing \>70% coronary artery stenosis; history of revascularization; pathologic Q waves on EKG); poorly controlled resting hypertension (SBP\>160/ DBP\>95); congestive heart failure (CHF) (as defined by left ventricular ejection fraction (LVEF) \<55%; physical exam findings of CHF; symptomatic pulmonary edema); significant (\>mild) valvular heart disease; congenital heart disease; cardiac arrhythmias including frequent premature atrial or ventricular contractions (\>5 per minute).
History of clinically overt pulmonary disease that may interfere with study procedures, including: greater than mild asthma, COPD, emphysema, chronic interstitial lung disease, and pulmonary hypertension.
Neuromuscular disorders or physical disability to perform exercise testing using an ergometer.
Significant history of recreational drug use other than marijuana as defined by: recreational drug use within the last 30 years of recruitment (or) recreational drug use at a frequency of more than once a month before 30 years.
Marijuana use more than once a week.
Other uncontrolled chronic illnesses which in the judgment of the study physician would interfere with completing study procedures.
Failure to keep screening appointments or other indicators of non-adherence.
Concomitant participation in another interventional study.
Subjects with BMI \<15 or \>40 kg/m2.
  • Mean Left Ventricular Ejection Fraction (LVEF)Baseline, approximately 1 day

    LVEF will be measured using Magnetic Resonance Imaging (MRI) using General Electric 1.5 Tesla MRI system without gadolinium contrast. In accordance with the American College of Cardiology (ACC), results will be reported quantitatively and qualitatively as follows: Hyperdynamic = LVEF greater than 70%, Normal = LVEF 50% to 70% (midpoint 60%), Mild dysfunction = LVEF 40% to 49% (midpoint 45%), Moderate dysfunction = LVEF 30% to 39% (midpoint 35%), Severe dysfunction = LVEF less than 30%.

  • Mean Aortic pulse wave velocity (PWV)Baseline, approximately 1 day

    Aortic pulse wave velocity (PWV) is a marker of aortic stiffness and will be measured (in meters/second) by regional PWV measurement in the thoracic aorta from the MRI (General Electric 1.5 Tesla MRI system without gadolinium contrast).

  • Change in Prevalence of CD14++CD16-Up to 10 weeks

    CD14++CD16- are markers of pro-inflammatory phenotypes that will be measured among peripheral blood monocytes using mass cytometry.

  • Change in Mean Peak Oxygen Consumption (VO2 Peak) LevelUp to 10 weeks

    VO2 Peak is the peak rate of oxygen consumption in milliliters per kilogram per minute (mL/(kg·min) measured during incremental exercise on a Cardio-Pulmonary Exercise Test (CPET). Patients are encouraged to exercise to their maximum endurance or until the nurse ends exercise due to symptoms like pain, dizziness, syncope, excessive dyspnea, or leg discomfort.