Hiatal Hernia and Pulmonary Involvement
Completed
Conditions studied: Hiatal Hernia, Interstitial Lung Disease
In brief
Patients often present with a significant burden of fibrosis upon diagnosis as there is interest in identifying these individuals earlier in their disease course (i.e., "subclinical disease") where targeted treatments and modification of risk factors may curb their progression to fulminant fibrosing ILD. The investigators have investigated with computed tomography (CT) methods such as interstitial lung abnormalities (ILA) and high attenuation areas (HAAs) that may detect early radiological signs of interstitial lung inflammation and scarring and novel modifiable risk factors that contribute to its pathogenesis. Among adults without clinically-diagnosed pulmonary fibrosis, those with a hiatal hernia will have higher levels of pepsin in bronchoalveolar lavage fluid (BALF) compared with adults without a hiatal hernia. Secondarily, examinination on whether there are differences in other reflux contents from BALF including total bile, and peripheral biomarkers related to lung injury and fibrogenesis which include matrix metalloproteinase-7 (MMP-7), vascular cell adhesion molecule 1 (VCAM-1), and cancer antigen 125 (CA-125).
Key facts
- Study ID
- NCT05716022
- Run by
- University of Virginia
- People needed
- 14
- Starts
- 2023-01-05
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2026-03-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Able to provide written consent.
- Clinical diagnosis of hiatal hernia and/or gastroesophageal reflux undergoing pre-operative evaluation for surgical repair at the University of Virginia as part of clinical care.
- 18 years and above.
You may not qualify if…
- Unable to provide written consent.
- Clinical diagnosis of pulmonary fibrosis.
- History of hiatal hernia (for control group only).
- Use of home supplemental oxygen therapy either at rest or exertion.
- Pregnant Women (will be confirmed as part of standard of care).
Where it is running
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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