Secondhand Tobacco Smoke and Cardiovascular Disease

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Flight Attendant Medical Research Institute
• Treatments: Angiotensin II; Angiotensin Receptor Antagonists; Antihypertensive Agents; Losartan

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.