Status:
RECRUITING
Secondhand Tobacco Smoke and Cardiovascular Disease
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Flight Attendant Medical Research Institute
Conditions:
Cardiovascular Diseases
Hypertension
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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 i...
Detailed Description
Secondhand tobacco smoke (SHS) remains a major public health problem.This is important particularly as the generations that endured the highest amount of SHS exposure are aging, which could potentiall...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04715568
Start Date
March 30 2021
End Date
December 31 2026
Last Update
July 23 2025
Active Locations (1)
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1
San Francisco Veterans' Affairs Medical Center
San Francisco, California, United States, 94121