Recruiting

Cardiovascular Disease

Sponsor:

UCLA

Code:

NCT04715568

Conditions

Cardiovascular Diseases

Hypertension

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Losartan

Placebo

Study Details

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.

Conditions

Cardiovascular Diseases

Hypertension

Study ID

NCT04715568

Start date

Mar 30, 2021

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Placebo then Losartan

Placebo tablets will be administered for the first 4 weeks followed by a washout period of 2 weeks. After the washout period has been completed, losartan tablets will be administered for the next 4 weeks.

experimental: Losartan then Placebo

Losartan tablets will be administered for the first 4 weeks followed by a washout period of 2 weeks. After the washout period has been completed, placebo tablets will be administered for the next 4 weeks.

Interventions

Losartan

50 mg tablets taken orally

Placebo

Tablets taken orally

Primary outcome measure

  • Mean Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Baseline, approximately 1 day ]
  • Mean Aortic pulse wave velocity (PWV) [ Time Frame: Baseline, approximately 1 day ]
  • Change in Prevalence of CD14++CD16- [ Time Frame: Up to 10 weeks ]
  • Change in Mean Peak Oxygen Consumption (VO2 Peak) Level [ Time Frame: Up to 10 weeks ]

Central Contacts and Locations

Central contacts

Mehrdad Arjomandi, MD

(415)221-4810mehrdad.arjomandi@ucsf.edu

Locations

San Francisco Veterans' Affairs Medical Center

Recruiting

San Francisco, California, United States, 94121

Contacts

Mehrdad Arjomandi, MD

415-221-4810mehrdad.arjomandi@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Second Hand Tobacco Smoke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-08-19.