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Recruiting
NCT04715568
Secondhand Tobacco Smoke and Cardiovascular Disease
Conditions: Cardiovascular Diseases, Hypertension
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 100
Sponsor: University of California, San Francisco
Location: San Francisco Veterans' Affairs Medical Center San Francisco California
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.
Eligibility Criteria
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 \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) \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 \40 kg/m2.
* MRI Scan Participation Exclusion Criteria - The participants will be excluded from the MRI portion of the study if they have a metallic object embedded or implanted in their body that is incompatible with Magnetic Resonance (MR) scanning, including MR incompatible pacemaker or defibrillator.
Source: ClinicalTrials.gov (NCT04715568). StuddyBuddy aggregates publicly available trial information.