Cardiovascular DiseasesPhase 4NCT04715568
Secondhand Tobacco Smoke and Cardiovascular Disease
A Phase 4 study testing Losartan in people with Cardiovascular Diseases and Hypertension, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular Diseases, Hypertension
- What is being tested?
- Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco Veterans' Affairs Medical Center
San Francisco, California, 94121
Mehrdad Arjomandi, MD, 415-221-4810 ext. 24393, mehrdad.arjomandi@ucsf.edu
About this study
Official title: Occult Cardiovascular Disease With Chronic Exposure to Secondhand Tobacco Smoke
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.
Read the 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 potentially accentuate the SHS-related occult health problems that may have been previously too subtle to be recognized. Although acute and subacute health effects of exposure to SHS have been studied, its long-term consequences have been more difficult to examine in part due to challenges with exposure assessment. Nonsmoking flight attendants (FA) who worked on commercial aircrafts before the enactment of the smoking ban were exposed to heavy SHS in aircraft cabin for many years, in a range similar to the nicotine exposure burden experienced by "light" smokers. The regularity of this intense exposure in the cabin work environment lends itself to relatively accurate SHS exposure quantification through employment history, and makes the exposed FA a unique population in which the long-term health effects of previous exposure to SHS could be examined as a form of "natural" experiment that is also generalizable to other SHS exposed populations.
Over the past several years, the investigators recruited a nonsmoking cohort of FA with such history of cabin SHS exposure who had subclinical signs and symptoms of pulmonary disease. Furthermore, while the FA in this cohort had no history of known cardiovascular disease, and were able to perform well on maximum effort exercise testing, they had an abnormal cardiovascular (hypertensive) response to exercise (HRE) that was associated with their cabin SHS exposure. Subtle abnormal cardiovascular response to exercise in the absence of overt disease, such as what the investigators observed in this cohort, has been described in other populations with likely subclinical disease and is suggested to be associated with impaired cardiovascular function with potential future adverse outcomes. However, the underlying mechanisms that contribute to these abnormal cardiovascular responses are unclear, and the rationale for initiation of preventative medical interventions in this setting remains unproven. Thus, the nature and clinical significance of these subtle abnormalities demands further investigation.
The hypothesis of this study is that:
- Prolonged exposure to secondhand tobacco smoke (SHS), even when remote, is associated with occult cardiovascular disease as determined by (a) abnormal cardiac structure and function, (b) abnormal vascular structure and function, and (c) abnormal circulatory mediators, which altogether generate a hypertensive response to exertion and limit exercise capacity.
- Management of hypertensive response to exercise (HRE) via blocking of the renin-angiotensin system, using an angiotensin-converting enzyme (ACE) receptor blocker, reduces the hypertensive response and improves exercise capacity, proxies for long-term cardiovascular health outcomes.
The investigators will investigate the above hypothesis through the following specific aims:
Specific Aim 1- Determine whether hypertensive response to exercise (HRE) is associated with abnormal cardiac and/or vascular structure and function in flight attendants (FA) with prolonged cabin SHS exposure but without overt cardiovascular disease. The investigators will perform cardiac magnetic resonance imaging (MRI) to measure myocardial dimensions and function including left ventricular (LV) mass, volume, ejection fraction (LVEF), and diastolic function. The investigators will also measure aortic stiffness by regional pulse wave velocity (PWV) measurement in the thoracic aorta from the MRI. The investigators will then examine the associations of these outcomes with SHS exposure and HRE.
Specific Aim 2- Determine whether HRE is associated with abnormal circulatory markers of cardiovascular disease in those with prolonged SHS exposure but without overt disease. The investigators will examine subjects' peripheral blood samples for circulatory markers of systemic inflammation, vascular function, and prothrombotic state including ACE, C-reactive protein (CRP), endothelin-1 (ET-1), P-selectin, fibrinogen, and von Willebrand Factor (vWF). Moreover, the investigators will perform molecular phenotyping of peripheral blood monocytes, an important culprit in atherogenesis, using mass cytometry in search for a proinflammatory profile associated with cardiovascular disease. The investigators will then examine the associations of these outcomes with HRE and SHS exposure.
Specific Aim 3- Determine whether short-term treatment with an ACE receptor blocker (Losartan) improves HRE and exercise capacity in those with prolonged exposure to SHS but without overt cardiovascular disease. The investigators will perform a placebocontrolled double-blind randomized controlled trial (RCT) in subjects with HRE but without known cardiovascular disease to determine the efficacy (and safety) of blocking the reninangiotensin system in reducing HRE and improving exercise capacity, a proxy for improved cardiovascular health.
- Conditions
- Cardiovascular Diseases, Hypertension
- Being tested
- Losartan, Placebo
- Keywords
- Second Hand Tobacco Smoke
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar, Angiotensin II Receptor Blocker, Antihypertensive
50 mg tablets taken orally
PlaceboDrug
Also called Inactive drug
Tablets taken orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo then Losartan | Experimental | 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. Receives: Drug: Losartan; Drug: Placebo |
| Losartan then Placebo | Experimental | 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. Receives: Drug: Losartan; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Left Ventricular Ejection Fraction (LVEF)
LVEF will be measured using Magnetic Resonance Imaging (MRI) using General Electric 1.5 Tesla MRI system without gadolinium contrast. In accordance with the American College of Cardiology (ACC), results will be reported quantitatively and qualitatively as follows: Hyperdynamic = LVEF greater than 70%, Normal = LVEF 50% to 70% (midpoint 60%), Mild dysfunction = LVEF 40% to 49% (midpoint 45%), Moderate dysfunction = LVEF 30% to 39% (midpoint 35%), Severe dysfunction = LVEF less than 30%.
Measured: Baseline, approximately 1 day
Mean Aortic pulse wave velocity (PWV)
Aortic pulse wave velocity (PWV) is a marker of aortic stiffness and will be measured (in meters/second) by regional PWV measurement in the thoracic aorta from the MRI (General Electric 1.5 Tesla MRI system without gadolinium contrast).
Measured: Baseline, approximately 1 day
Change in Prevalence of CD14++CD16-
CD14++CD16- are markers of pro-inflammatory phenotypes that will be measured among peripheral blood monocytes using mass cytometry.
Measured: Up to 10 weeks
Change in Mean Peak Oxygen Consumption (VO2 Peak) Level
VO2 Peak is the peak rate of oxygen consumption in milliliters per kilogram per minute (mL/(kg·min) measured during incremental exercise on a Cardio-Pulmonary Exercise Test (CPET). Patients are encouraged to exercise to their maximum endurance or until the nurse ends exercise due to symptoms like pain, dizziness, syncope, excessive dyspnea, or leg discomfort.
Measured: Up to 10 weeks
Secondary outcomes (15)
Mean Left Ventricular Mass
Left ventricular mass will be measured (in grams/m2) using cardiac MRI (General Electric 1.5 Tesla MRI system without gadolinium contrast).
Measured: Baseline, approximately 1 day
Mean Left Ventricular Volume
Left ventricular volume will be measured (in mL) using cardiac MRI (General Electric 1.5 Tesla MRI system without gadolinium contrast).
Measured: Baseline, approximately 1 day
Change in Mean Angiotensin Converting Enzyme (ACE) Level
ACE is a central component of the renin-angiotensin system (RAS), which controls blood pressure by regulating the volume of fluids in the body. Level of ACE will be measured in micrograms per liter from peripheral blood sample.
Measured: Up to 10 weeks
Change in Mean C-Reactive Protein (CRP) Level
CRP is an acute phase reactant and will be measured (in mg/L) from peripheral blood sample.
Measured: At baseline assessment (V1); 4th week of V2 (placebo/losartan) treatment period; and 4th week of V3 (placebo/losartan) treatment period
Change in Mean Endothelin-1 Level
Endothelin-1 is a potent vasoconstrictor produced by vascular endothelial cells and will be measured from peripheral blood sample.
Measured: Up to 10 weeks
Change in Mean P-selectin Level
P-selectin is a transmembrane glycoprotein that functions as a cell adhesion molecule on the surfaces of activated endothelial cells and will be measured from peripheral blood sample.
Measured: Up to 10 weeks
Change in Mean Fibrinogen Level
Fibrinogen is a glycoprotein that plays a pivotal role in normal homeostasis as a substrate for conversion to fibrin and a facilitator of wound healing. It will be measured in milligrams per deciliter from peripheral blood sample.
Measured: Up to 10 weeks
Change in Mean von Willebrand Factor (VWF)
VWF is a large multimeric glycoprotein that performs critical functions in primary hemostasis. It will be measured in micrograms per deciliter from peripheral blood sample.
Measured: Up to 10 weeks
Change in Mean Maximum Workload
The maximum amount of workload achieved (in watts) during an incremental CPET.
Measured: Up to 10 weeks
Change in Mean Maximum Oxygen Pulse
Oxygen pulse is the ratio between Oxygen consumption (VO2) and heart rate. The maximum O2-pulse (mL/beat), a proxy for stroke volume, will be measured during incremental CPET.
Measured: Up to 10 weeks
Change in Mean Slope of Systolic Blood Pressure (SBP)
The rate at which the SBP increases over the workload achieved in watts during an incremental CPET is the Slope of SBP.
Measured: Up to 10 weeks
Change in Mean Slope of Diastolic Blood Pressure (DBP)
The rate at which the DBP increases over the workload achieved in watts during an incremental CPET is the Slope of DBP.
Measured: Up to 10 weeks
Change in Mean Slope of Heart Rate (HR)
The rate at which the HR increases over the workload achieved in watts during an incremental CPET is the Slope of HR.
Measured: Up to 10 weeks
Change in Mean Change in Borg Score
Borg Rating of perceived exertion is a widely used and reliable indicator to monitor and guide exercise intensity. The scale allows individuals to subjectively rate their level of exertion during exercise testing. The revised category-ratio scale (0 to 10 scale) will be used, where 0 indicates no perceived exertion and 10 indicates maximal perceived exertion.
Measured: Up to 10 weeks
Change in Mean Moderate-to-Vigorous Physical Activity (MVPA)
MVPA is measured with Metabolic Equivalents (METs). A MET is the ratio of a person's working metabolic rate compared to their resting metabolic rate. MVPA is any activity over 3 METs. An Actigraph monitor will be used to measure MVPA.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start30 Mar 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind randomized placebo-controlled crossover clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Mehrdad Arjomandi, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715568
- Sponsor's protocol ID
- 20-30189
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2020
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbaspour Kaboudan F, Zeng S, Abrham Y, Roman J, Butner K, Merati M, Arjomandi M. Determinants of Reclassification of Exercise Performance across Cardiopulmonary Exercise Testing Prediction Equations. Med Sci Sports Exerc. 2026 Nov 1;58(11):2570-2580. doi: 10.1249/MSS.0000000000004065. Epub 2026 Jul 3.
PubMed 42492489
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occult Cardiovascular Disease With Chronic Exposure to Secondhand Tobacco Smoke
- ClinicalTrials.gov ID
- NCT04715568
- Acronym / sponsor ID
- 20-30189
- Conditions
- Cardiovascular Diseases, Hypertension
- Keywords
- Second Hand Tobacco Smoke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 potentially accentuate the SHS-related occult health problems that may have been previously too subtle to be recognized. Although acute and subacute health effects of exposure to SHS have been studied, its long-term consequences have been more difficult to examine in part due to challenges with exposure assessment. Nonsmoking flight attendants (FA) who worked on commercial aircrafts before the enactment of the smoking ban were exposed to heavy SHS in aircraft cabin for many years, in a range similar to the nicotine exposure burden experienced by "light" smokers. The regularity of this intense exposure in the cabin work environment lends itself to relatively accurate SHS exposure quantification through employment history, and makes the exposed FA a unique population in which the long-term health effects of previous exposure to SHS could be examined as a form of "natural" experiment that is also generalizable to other SHS exposed populations.
Over the past several years, the investigators recruited a nonsmoking cohort of FA with such history of cabin SHS exposure who had subclinical signs and symptoms of pulmonary disease. Furthermore, while the FA in this cohort had no history of known cardiovascular disease, and were able to perform well on maximum effort exercise testing, they had an abnormal cardiovascular (hypertensive) response to exercise (HRE) that was associated with their cabin SHS exposure. Subtle abnormal cardiovascular response to exercise in the absence of overt disease, such as what the investigators observed in this cohort, has been described in other populations with likely subclinical disease and is suggested to be associated with impaired cardiovascular function with potential future adverse outcomes. However, the underlying mechanisms that contribute to these abnormal cardiovascular responses are unclear, and the rationale for initiation of preventative medical interventions in this setting remains unproven. Thus, the nature and clinical significance of these subtle abnormalities demands further investigation.
The hypothesis of this study is that:
- Prolonged exposure to secondhand tobacco smoke (SHS), even when remote, is associated with occult cardiovascular disease as determined by (a) abnormal cardiac structure and function, (b) abnormal vascular structure and function, and (c) abnormal circulatory mediators, which altogether generate a hypertensive response to exertion and limit exercise capacity.
- Management of hypertensive response to exercise (HRE) via blocking of the renin-angiotensin system, using an angiotensin-converting enzyme (ACE) receptor blocker, reduces the hypertensive response and improves exercise capacity, proxies for long-term cardiovascular health outcomes.
The investigators will investigate the above hypothesis through the following specific aims:
Specific Aim 1- Determine whether hypertensive response to exercise (HRE) is associated with abnormal cardiac and/or vascular structure and function in flight attendants (FA) with prolonged cabin SHS exposure but without overt cardiovascular disease. The investigators will perform cardiac magnetic resonance imaging (MRI) to measure myocardial dimensions and function including left ventricular (LV) mass, volume, ejection fraction (LVEF), and diastolic function. The investigators will also measure aortic stiffness by regional pulse wave velocity (PWV) measurement in the thoracic aorta from the MRI. The investigators will then examine the associations of these outcomes with SHS exposure and HRE.
Specific Aim 2- Determine whether HRE is associated with abnormal circulatory markers of cardiovascular disease in those with prolonged SHS exposure but without overt disease. The investigators will examine subjects' peripheral blood samples for circulatory markers of systemic inflammation, vascular function, and prothrombotic state including ACE, C-reactive protein (CRP), endothelin-1 (ET-1), P-selectin, fibrinogen, and von Willebrand Factor (vWF). Moreover, the investigators will perform molecular phenotyping of peripheral blood monocytes, an important culprit in atherogenesis, using mass cytometry in search for a proinflammatory profile associated with cardiovascular disease. The investigators will then examine the associations of these outcomes with HRE and SHS exposure.
Specific Aim 3- Determine whether short-term treatment with an ACE receptor blocker (Losartan) improves HRE and exercise capacity in those with prolonged exposure to SHS but without overt cardiovascular disease. The investigators will perform a placebocontrolled double-blind randomized controlled trial (RCT) in subjects with HRE but without known cardiovascular disease to determine the efficacy (and safety) of blocking the reninangiotensin system in reducing HRE and improving exercise capacity, a proxy for improved cardiovascular health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized placebo-controlled crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| Placebo then Losartan | Experimental | Drug: Losartan, Drug: PlaceboPlacebo 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. |
| Losartan then Placebo | Experimental | Drug: Losartan, Drug: PlaceboLosartan 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LosartanAlso: Cozaar, Angiotensin II Receptor Blocker, Antihypertensive50 mg tablets taken orally | Drug | Losartan then Placebo, Placebo then Losartan |
| PlaceboAlso: Inactive drugTablets taken orally | Drug | Losartan then Placebo, Placebo then Losartan |
Primary outcome
Mean Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline, approximately 1 day
LVEF will be measured using Magnetic Resonance Imaging (MRI) using General Electric 1.5 Tesla MRI system without gadolinium contrast. In accordance with the American College of Cardiology (ACC), results will be reported quantitatively and qualitatively as follows: Hyperdynamic = LVEF greater than 70%, Normal = LVEF 50% to 70% (midpoint 60%), Mild dysfunction = LVEF 40% to 49% (midpoint 45%), Moderate dysfunction = LVEF 30% to 39% (midpoint 35%), Severe dysfunction = LVEF less than 30%.
Mean Aortic pulse wave velocity (PWV)
Time frame: Baseline, approximately 1 day
Aortic pulse wave velocity (PWV) is a marker of aortic stiffness and will be measured (in meters/second) by regional PWV measurement in the thoracic aorta from the MRI (General Electric 1.5 Tesla MRI system without gadolinium contrast).
Change in Prevalence of CD14++CD16-
Time frame: Up to 10 weeks
CD14++CD16- are markers of pro-inflammatory phenotypes that will be measured among peripheral blood monocytes using mass cytometry.
Change in Mean Peak Oxygen Consumption (VO2 Peak) Level
Time frame: Up to 10 weeks
VO2 Peak is the peak rate of oxygen consumption in milliliters per kilogram per minute (mL/(kg·min) measured during incremental exercise on a Cardio-Pulmonary Exercise Test (CPET). Patients are encouraged to exercise to their maximum endurance or until the nurse ends exercise due to symptoms like pain, dizziness, syncope, excessive dyspnea, or leg discomfort.
15 secondary outcomes
Mean Left Ventricular Mass
Time frame: Baseline, approximately 1 day
Mean Left Ventricular Volume
Time frame: Baseline, approximately 1 day
Change in Mean Angiotensin Converting Enzyme (ACE) Level
Time frame: Up to 10 weeks
Change in Mean C-Reactive Protein (CRP) Level
Time frame: At baseline assessment (V1); 4th week of V2 (placebo/losartan) treatment period; and 4th week of V3 (placebo/losartan) treatment period
Change in Mean Endothelin-1 Level
Time frame: Up to 10 weeks
Change in Mean P-selectin Level
Time frame: Up to 10 weeks
Change in Mean Fibrinogen Level
Time frame: Up to 10 weeks
Change in Mean von Willebrand Factor (VWF)
Time frame: Up to 10 weeks
Change in Mean Maximum Workload
Time frame: Up to 10 weeks
Change in Mean Maximum Oxygen Pulse
Time frame: Up to 10 weeks
Change in Mean Slope of Systolic Blood Pressure (SBP)
Time frame: Up to 10 weeks
Change in Mean Slope of Diastolic Blood Pressure (DBP)
Time frame: Up to 10 weeks
Change in Mean Slope of Heart Rate (HR)
Time frame: Up to 10 weeks
Change in Mean Change in Borg Score
Time frame: Up to 10 weeks
Change in Mean Moderate-to-Vigorous Physical Activity (MVPA)
Time frame: Up to 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 42492489Abbaspour Kaboudan F, Zeng S, Abrham Y, Roman J, Butner K, Merati M, Arjomandi M. Determinants of Reclassification of Exercise Performance across Cardiopulmonary Exercise Testing Prediction Equations. Med Sci Sports Exerc. 2026 Nov 1;58(11):2570-2580. doi: 10.1249/MSS.0000000000004065. Epub 2026 Jul 3.
- University of California, San Francisco (UCSF) website for Arjomandi LabLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mehrdad Arjomandi, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Losartan in people with Cardiovascular Diseases and Hypertension, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehrdad Arjomandi, MD ((415)221-4810 ext. 24393, mehrdad.arjomandi@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Left Ventricular Ejection Fraction (LVEF) (time frame: Baseline, approximately 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.