RECRUITING

Secondhand Tobacco Smoke and Cardiovascular Disease

Conditions

Cardiovascular Diseases Hypertension Second Hand Tobacco Smoke

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Occult Cardiovascular Disease With Chronic Exposure to Secondhand Tobacco Smoke

Quick Facts

Study Start:2021-03-30

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04715568

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Mehrdad Arjomandi, MD

CONTACT

(415)221-4810

mehrdad.arjomandi@ucsf.edu

Principal Investigator

Mehrdad Arjomandi, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

San Francisco Veterans' Affairs Medical Center

San Francisco, California, 94121

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Mehrdad Arjomandi, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-30

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-03-30

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Second Hand Tobacco Smoke

Additional Relevant MeSH Terms

Cardiovascular Diseases
Hypertension