Secondhand Tobacco Smoke and Cardiovascular Disease

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Cardiovascular Diseases, Hypertension

In brief

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.

Key facts

Study ID

NCT04715568

Run by

University of California, San Francisco

People needed

100

Starts

2021-03-30

Expected to finish

2026-12-31

Last updated by the study team

2025-07-23

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• San Francisco Veterans' Affairs Medical Center — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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