NCT04715568 Secondhand Tobacco Smoke and Cardiovascular Disease
| NCT ID | NCT04715568 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, San Francisco |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-03-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2021-03-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 individuals with pre-Chronic Obstructive Pulmonary Disease (COPD) due to prolonged exposure to secondhand tobacco 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.
Contact & Investigator
Mehrdad Arjomandi, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT04715568 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04715568 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04715568 currently recruiting?
Yes, NCT04715568 is actively recruiting participants. Contact the research team at mehrdad.arjomandi@ucsf.edu for enrollment information.
Where is the NCT04715568 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT04715568 clinical trial?
NCT04715568 is sponsored by University of California, San Francisco. The principal investigator is Mehrdad Arjomandi, MD at University of California, San Francisco. The trial plans to enroll 100 participants.