Secondhand Tobacco Smoke and Cardiovascular Disease

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jan 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called losartan, which is already approved by the FDA, can help improve heart and lung health in people who have been exposed to secondhand tobacco smoke for a long time. The trial specifically focuses on individuals over the age of 40 who have worked in places like airlines or casinos where they inhaled secondhand smoke for at least five years. To participate, you should not be a current smoker and must have not smoked heavily in the past.

If you decide to join the study, you will be randomly assigned to receive either losartan or a placebo (a dummy pill that has no active ingredients) during different periods. This means that neither you nor the researchers will know which treatment you are getting at any given time. Throughout the trial, researchers will monitor your health to see if the medication helps improve your heart and lung function. Additionally, it's important to note that there are specific health conditions that may disqualify you from participating, so please consider discussing your eligibility with your doctor.

Gender

ALL

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 \<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.