Lung and Heart Function Across Decades of Life in Health

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspnea; Pollution; Exposure; Pollution Related Respiratory Disorder; Cardiopulmonary
• Intervention / Treatment: Other: Healthy control

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Mehrdad Arjomandi, MD; Phone Number: 24393 415-221-4810; Email: mehrdad.arjomandi@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
      • Contact: Mehrdad Arjomandi, MD; Phone Number: 24393 415-221-4810; Email: mehrdad.arjomandi@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Age 24-68
• No respiratory complaints (defined as modified Medical Research Council score = 0)
• No use of respiratory medications

Exclusion Criteria:

• 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
• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	2 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: US Department of Veterans Affairs
• Investigators: Principal Investigator: Mehrdad Arjomandi, MD, University of California, San Francisco

Publications and helpful links

General 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.
• Zeng 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Echocardiography; Cardiopulmonary exercise testing; Pulmonary function testing; Cardiopulmonary function; Forced oscillometry testing; Computed tomography imaging
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dyspnea
• Other Study ID Numbers: UCSF IRB#24-41051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No