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NCT Number: NCT07641413

Lung and Heart Function Across Decades of Life in Health

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.

Recruiting

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Key information

Age range

24 year–68 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Mehrdad Arjomandi, MD

CONTACT

[email protected]

415-221-4810 ext. 24393

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Healthy Control

Other

Observational study with no intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.

    Time frame: 2 years

    FeNO: The purpose of this test is to measure a marker of inflammation in the lungs.

  2. Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.

    Time frame: 2 years

    Forced Oscillation Technique: The purpose of this test is to determine the resistance of the airways in the subject's lungs.

  3. Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.

    Time frame: 2 years

    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.

  4. Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.

    Time frame: 2 years

    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.

  5. Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.

    Time frame: 2 years

    Peripheral Blood Draw: The purpose of this blood draw is to determine metabolic and blood inflammatory markers.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehrdad Arjomandi, MD

CONTACT

[email protected]

415-221-4810 ext. 24393

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

Lung and Heart Function Across Decades of Life in Healthy Population

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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