Pollution Related Respiratory DisorderNCT07641413
Lung and Heart Function Across Decades of Life in Health
An observational study of Pollution Related Respiratory Disorder and Pollution; Exposure, run by University of California, San Francisco at 1 site in United States.
Trial summary
The main objective of this study is to develop baseline "normal" reference values of both lung and heart function for healthy adults within the age range relevant to the United States Veteran population who served in the Southwest Asia theater of military operations. Read more about this study
- Who is it for?
- Ages 24 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Pollution Related Respiratory Disorder, Pollution; Exposure, Dyspnea
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Dec 2030
- Phase
- Observational
- 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 24 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy "normal" adults within the age range relevant to the United States Veteran population who served in the Southwest Asia theater of military operations.
Who may be able to join
- Age 24-68
- U.S. Veteran deployed between 1990 to 2021
- No respiratory complaints (defined as modified Medical Research Council score = 0)
- No use of respiratory medications
Who cannot join
- Non-English speaking
- Pregnancy
- BMI>35 Kg/m2
- Tobacco smoking within prior year
- Lifetime tobacco smoking of >5 pack-years
- Current inhaled cannabis use (any modality) >2x weekly
Show all 17Show fewer
- Prior inhaled cannabis uses exceeding 2x weekly within the prior year
- Illicit drug use (other than cannabis)
- No prior or current major organ disease, including but not limited to:
- Neuromuscular weakness
- History of malignancy (other than non-melanoma skin cancer)-- HIV/AIDS
- Autoimmune disease
- Solid-organ or hematopoietic stem cell transplant
- Cardiovascular disease (other than mild HTN; < 140/90; controlled on 2 or less medications)
- Poorly-controlled HTN (SBP>140 or DBP>90 or use of more than 2 anti-hypertensive medications)
- Any history of congestive heart failure (CHF, either HFpEF or HFrEF)
- Any history of arrythmia (including atrial fibrillation)
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
University of California San Francisco
San Francisco, California, 94143
Mehrdad Arjomandi, MD, 415-221-4810 ext. 24393, mehrdad.arjomandi@ucsf.edu
About this study
Official title: Lung and Heart Function Across Decades of Life in Healthy Population
The main objective of this study is to develop baseline "normal" reference values of both lung and heart function for healthy adults within the age range relevant to the United States Veteran population who served in the Southwest Asia theater of military operations.
This study will involve performing key components of the Department of Veterans Affairs the Airborne Hazards and Open Burn Pit Center of Excellence (AHOBPCE) and a VA network of Post-Deployment Cardiopulmonary Evaluation Network (PDCEN) Core Clinical Evaluation in asymptomatic unexposed healthy controls without known lung or heart disease to serve as a "normal" control comparator group for veterans evaluated by PDCEN.
Read the detailed description
This is an observational study to recruit and thoroughly characterize 200 age- and gender-matched healthy controls without a history of exposure to airborne hazards. The childhood health and disease profiles of participants will also be evaluated to provide assessment of their physical fitness as adolescents. The participants will undergo detailed clinical, physiological, and radiological evaluations that will match the PDCEN Core Clinical Evaluation, which includes administration of health, environmental and occupational exposures, respiratory, and physical fitness questionnaires, pulmonary function testing (PFT), forced oscillometry (FOT), cardiopulmonary exercise testing (CPET) with maximum effort, dynamic hyperinflation, and exercise-induced bronchospasm protocols, methacholine challenge testing, transthoracic echocardiography, and computer tomography (CT) of chest, as well as pulmonary and systemic biomarker analysis including fractional exhalation of nitric oxide (FeNO) and peripheral blood sampling for blood count and metabolic panel including liver and kidney function.
- Being tested
- Healthy control
- Keywords
- Cardiopulmonary function, Pulmonary function testing, Forced oscillometry testing, Echocardiography, Cardiopulmonary exercise testing, Computed tomography imaging
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy controlOther
Observational study with no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Pulmonary Function Testing: The purpose of this test is to determine the participant's lungs' capacity.
Measured: 2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Cardiopulmonary Exercise Testing: The purpose of this test is to determine the participant's lung and heart capacity during maximum exercise.
Measured: 2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Echocardiogram: The purpose of this test is to determine how well the subject's heart is functioning and identify causes of cardiac-related symptoms.
Measured: 2 years
Secondary outcomes (5)
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
FeNO: The purpose of this test is to measure a marker of inflammation in the lungs.
Measured: 2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Forced Oscillation Technique: The purpose of this test is to determine the resistance of the airways in the subject's lungs.
Measured: 2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Methacholine Challenge Test: The purpose of this test is to determine how irritable the participant's airways are by administering gradually increasing doses of methacholine.
Measured: 2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Chest CT: The purpose of this test is to examine for abnormalities and to help diagnose the cause of signs or symptoms of chest disease.
Measured: 2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Peripheral Blood Draw: The purpose of this blood draw is to determine metabolic and blood inflammatory markers.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Aug 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pollution Related Respiratory DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Mehrdad Arjomandi, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641413
- Sponsor's protocol ID
- UCSF IRB#24-41051
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng S, Nishihama M, Weldemichael L, Lozier H, Gold WM, Arjomandi M. Effect of twice daily inhaled albuterol on cardiopulmonary exercise outcomes, dynamic hyperinflation, and symptoms in secondhand tobacco-exposed persons with preserved spirometry and air trapping: a randomized controlled trial. BMC Pulm Med. 2024 Jan 20;24(1):44. doi: 10.1186/s12890-023-02808-7.
PubMed 38245665Zeng S, Dunn M, Gold WM, Kizer JR, Arjomandi M. Remote exposure to secondhand tobacco smoke is associated with lower exercise capacity through effects on oxygen pulse, a proxy of cardiac stroke volume. BMJ Open Respir Res. 2022 May;9(1):e001217. doi: 10.1136/bmjresp-2022-001217.
PubMed 35551073
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung and Heart Function Across Decades of Life in Healthy Population
- ClinicalTrials.gov ID
- NCT07641413
- Acronym / sponsor ID
- UCSF IRB#24-41051
- Keywords
- Cardiopulmonary function, Pulmonary function testing, Forced oscillometry testing, Echocardiography, Cardiopulmonary exercise testing, Computed tomography imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Jun 2026 (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.
The main objective of this study is to develop baseline "normal" reference values of both lung and heart function for healthy adults within the age range relevant to the United States Veteran population who served in the Southwest Asia theater of military operations.
This study will involve performing key components of the Department of Veterans Affairs the Airborne Hazards and Open Burn Pit Center of Excellence (AHOBPCE) and a VA network of Post-Deployment Cardiopulmonary Evaluation Network (PDCEN) Core Clinical Evaluation in asymptomatic unexposed healthy controls without known lung or heart disease to serve as a "normal" control comparator group for veterans evaluated by PDCEN.
Detailed description
This is an observational study to recruit and thoroughly characterize 200 age- and gender-matched healthy controls without a history of exposure to airborne hazards. The childhood health and disease profiles of participants will also be evaluated to provide assessment of their physical fitness as adolescents. The participants will undergo detailed clinical, physiological, and radiological evaluations that will match the PDCEN Core Clinical Evaluation, which includes administration of health, environmental and occupational exposures, respiratory, and physical fitness questionnaires, pulmonary function testing (PFT), forced oscillometry (FOT), cardiopulmonary exercise testing (CPET) with maximum effort, dynamic hyperinflation, and exercise-induced bronchospasm protocols, methacholine challenge testing, transthoracic echocardiography, and computer tomography (CT) of chest, as well as pulmonary and systemic biomarker analysis including fractional exhalation of nitric oxide (FeNO) and peripheral blood sampling for blood count and metabolic panel including liver and kidney function.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 24 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy "normal" adults within the age range relevant to the United States Veteran population who served in the Southwest Asia theater of military operations.
Key inclusion criteria (4 listed)
- Age 24-68
- U.S. Veteran deployed between 1990 to 2021
- No respiratory complaints (defined as modified Medical Research Council score = 0)
- No use of respiratory medications
Key exclusion criteria (17 listed)
- Non-English speaking
- Pregnancy
- BMI>35 Kg/m2
- Tobacco smoking within prior year
- Lifetime tobacco smoking of >5 pack-years
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 |
|---|---|---|
| Healthy controlObservational study with no intervention | Other | – |
Primary outcome
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Time frame: 2 years
Pulmonary Function Testing: The purpose of this test is to determine the participant's lungs' capacity.
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Time frame: 2 years
Cardiopulmonary Exercise Testing: The purpose of this test is to determine the participant's lung and heart capacity during maximum exercise.
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Time frame: 2 years
Echocardiogram: The purpose of this test is to determine how well the subject's heart is functioning and identify causes of cardiac-related symptoms.
5 secondary outcomes
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Time frame: 2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Time frame: 2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Time frame: 2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Time frame: 2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
Time frame: 2 years
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 14 Sep 2026.
- Background: PubMed 38245665Zeng S, Nishihama M, Weldemichael L, Lozier H, Gold WM, Arjomandi M. Effect of twice daily inhaled albuterol on cardiopulmonary exercise outcomes, dynamic hyperinflation, and symptoms in secondhand tobacco-exposed persons with preserved spirometry and air trapping: a randomized controlled trial. BMC Pulm Med. 2024 Jan 20;24(1):44. doi: 10.1186/s12890-023-02808-7.
- Background: PubMed 35551073Zeng S, Dunn M, Gold WM, Kizer JR, Arjomandi M. Remote exposure to secondhand tobacco smoke is associated with lower exercise capacity through effects on oxygen pulse, a proxy of cardiac stroke volume. BMJ Open Respir Res. 2022 May;9(1):e001217. doi: 10.1136/bmjresp-2022-001217.
- If you are interested, please fill out this brief survey and someone from our team will reach out to you.Link 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?
An observational study of Pollution Related Respiratory Disorder and Pollution; Exposure, 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 4 inclusion and 17 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 14 Sep 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.
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?
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population. (time frame: 2 years). The study lists 3 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 NCT07641413, which also lists 2 linked publications.
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 14 Sep 2026.