NCT07641413

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Aug 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Aug 2024Dec 2030

Study Start

First participant enrolled

August 1, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

6.4 years

First QC Date

June 1, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Cardiopulmonary functionPulmonary function testingForced oscillometry testingEchocardiographyCardiopulmonary exercise testingComputed tomography imaging

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

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

    2 years

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

    2 years

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

    2 years

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

    2 years

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

    2 years

Interventions

Observational study with no intervention

Eligibility Criteria

Age24 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 38245665BACKGROUND
  • 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.

    PMID: 35551073BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mehrdad Arjomandi, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehrdad Arjomandi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 11, 2026

Study Start

August 1, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations