Investigating the effects of secondhand tobacco smoke on heart health

Occult Cardiovascular Disease With Chronic Exposure to Secondhand Tobacco Smoke

This study is testing if a heart medication called losartan can help nonsmoking flight attendants who have been exposed to secondhand tobacco smoke and may have early signs of lung problems.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT04715568 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of losartan, an FDA-approved angiotensin receptor blocker, in improving cardiopulmonary outcomes for individuals with pre-Chronic Obstructive Pulmonary Disease (COPD) due to prolonged exposure to secondhand tobacco smoke. The study focuses on nonsmoking flight attendants who experienced significant secondhand smoke exposure before the smoking ban on aircraft. Participants will be randomly assigned to receive either losartan or a placebo in a double-blind crossover design, allowing for a direct comparison of treatment effects. The trial aims to uncover the long-term health impacts of secondhand smoke exposure, particularly in an aging population that has faced these risks.

Who should consider this trial

Good fit: Ideal candidates include adults aged 40 and older with a history of occupational exposure to secondhand tobacco smoke for at least 5 years and who have never smoked or have a very remote history of light smoking.

Not a fit: Patients who are currently taking angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or those with a history of angioedema may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for individuals suffering from cardiovascular issues related to secondhand tobacco smoke exposure.

How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated potential benefits of angiotensin receptor blockers in similar populations exposed to secondhand 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 \<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 this trial is running

San Francisco, California

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

Study contacts

• Principal investigator: Mehrdad Arjomandi, MD — University of California, San Francisco
• Study coordinator: Mehrdad Arjomandi, MD

Conditions Cardiovascular Diseases; Hypertension; Second Hand Tobacco Smoke