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New treatment option for Cardiovascular Diseases
Official title Secondhand Tobacco Smoke and Cardiovascular Disease
ClinicalTrials.gov ID: NCT04715568
What this study is testing
What is Losartan?
Losartan is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cardiovascular diseases.
Also referred to as Cozaar, Angiotensin II Receptor Blocker.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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...
- Must have never smoked or have a remote history of light smoking defined as follows:
- Lifetime smoking history equivalent to \< 1 pack-year and
You likely can't join if
- 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).
See the full eligibility 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...
- 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...
- 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...
- 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 treatment study.
- people with BMI \ 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.