Secondhand Tobacco Smoke and Cardiovascular Disease
United States100 participantsStarted 2021-03-30
Plain-language summary
This is a double-blind randomized placebo-controlled crossover clinical trial of efficacy and safety of an FDA-approved angiotensin receptor blocker (losartan) to improve cardiopulmonary outcomes in individuals with pre-Chronic Obstructive Pulmonary Disease (COPD) due to prolonged exposure to secondhand tobacco smoke.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 lev…
What they're measuring
1
Mean Left Ventricular Ejection Fraction (LVEF)
Timeframe: Baseline, approximately 1 day
2
Mean Aortic pulse wave velocity (PWV)
Timeframe: Baseline, approximately 1 day
3
Change in Prevalence of CD14++CD16-
Timeframe: Up to 10 weeks
4
Change in Mean Peak Oxygen Consumption (VO2 Peak) Level