Hiatal HerniaNCT05716022
Hiatal Hernia and Pulmonary Involvement
An observational study of Hiatal Hernia and Interstitial Lung Disease, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiatal Hernia, Interstitial Lung Disease
- What is being tested?
- Blood Collection and Bronchoscopy
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Participants without a clinical diagnosis of pulmonary fibrosis will be recruited from UVA medical center based on the absence of traction bronchiectasis, honeycombing and/or reticular opacities on CT Scan. 2. Case group will be adults who have a clinical diagnosis of hiatal hernia already scheduled to under surgical repair 3. Control group will be adults without a CT diagnosis of hiatal hernia who have been scheduled to undergo Bronchoscopy for lung nodule evaluation.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Hiatal Hernia and Pulmonary Involvement Related to Subclinical Lung Injury and Fibrosis
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).
Read the detailed description
Fibrosing interstitial lung diseases (ILDs) have significant morbidity and poor overall survival as the investigation of earlier stages of fibrosing ILDs may identify modifiable risk factors and elucidate its pathogenesis. Interstitial lung disease (ILD) constitutes a group of chronic respiratory illnesses that are characterized by repetitive injury to the lung parenchyma that may progress to fibrosis. Fibrosing ILDs, which include idiopathic pulmonary fibrosis (IPF) and other ILD types, can lead to chronic respiratory failure, and poor survival, is the most common indication for lung transplantation. While antifibrotics slow disease progression and may reduce mortality, they carry side effects and are frequently poorly tolerated by patients. Therefore, there is a critical need to identify novel therapeutic targets. 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.
Hiatal hernia and its promotion of gastroesophageal reflux have been implicated as a causal risk factor in pulmonary fibrosis. One potential modifiable risk factor is hiatal hernia and its promotion of gastroesophageal reflux (GER). Gastric materials in the lung induce parenchymal injury and fibrosis in pre-clinical models as GER may be a vehicle of repetitive lung injury that is then followed by aberrant wound healing and eventual fibrosis. Hiatal hernia, which is the protrusion of stomach contents in the thoracic cavity, can promote GER and is more prevalent in adults with pulmonary fibrosis compared with healthy controls and other chronic lung diseases. Further evidence comes from studies in which patients with IPF and other fibrosing ILDs (many of whom had a hiatal hernia) demonstrated elevated levels of pepsin in their bronchoalveolar lavage fluid (BALF), a significant component of reflux and measurable biomarker, compared with healthy controls and is associated with a higher risk of exacerbation. Much of these studies have been case-control and performed in adults with clinically-diagnosed fibrosing ILD which limits causal inferences. It has been hypothesized that fibrosis itself may promote GER due to impaired esophageal sphincter function due to reduced elasticity and more negative intrathoracic pressures. Whether hiatal hernia contributes to subclinical repetitive injury to the lung among adults without clinically-diagnosed ILD is a significant knowledge gap.
Overactivation of the mononuclear phagocyte immune system may contribute to developing fibrosing ILDs and their progression. Single-cell RNA sequencing (scRNA-seq) has accelerated our understanding of fibrosing ILD by identifying biological pathways related to certain cellular populations. Using scRNA-seq, our group and others have demonstrated that overactivation of the mononuclear phagocyte system, a key component of the innate immune system, may be critical in the pathogenesis of IPF with higher populations of monocytes found in the lungs and blood of patients with fibrosis. Higher levels of the absolute monocyte count in the blood are associated with disease progression and worse survival among adults with IPF. The investigators have extended these findings to earlier stages of ILD as higher monocyte counts are associated with more ILA and its progression on CT and a lower forced vital capacity. Notably, adults with ILA have more activated monocytes than those without ILA, suggesting a smoldering activation of innate immunity may prime an individual to developing ILD in combination with other risk factors (i.e., smoking, genetic variants, and hiatal hernia).
Radiologically-detected hiatal hernia is associated with a greater burden of CT interstitial lung abnormalities and worse survival among community-dwelling adults. In a population cohort of U.S. community-dwelling adults, investigators found that the presence of hiatal hernia on CT was associated with more HAAs and their progression over time and more ILA among younger adults. Notably, elevated HAAs on CT were associated with worse survival among those with a hiatal hernia compared with those without a hernia. Our findings suggest that hiatal hernia and its promotion of GER may contribute to subclinical injury and remodeling detected by imaging biomarkers. Whether subclinical abnormalities are detected in the lungs of adults with hiatal hernia remains a major knowledge gap that this study will address by examining BALF contents of adults with hiatal hernia.
- Conditions
- Hiatal Hernia, Interstitial Lung Disease
- Being tested
- Blood Collection, Bronchoscopy
- Keywords
- Hiatal Hernia, BALF, Interstitial lung Disease
- Medical subject headings
- Hernia, Hiatal, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood CollectionDiagnostic test
Prior to subject's surgical procedure, blood (about 3 tablespoons (44 mL)) will be collected through a needle in vein for research purposes. The UVA researchers will analyze the biomarkers that are expressed in subject's blood.
BronchoscopyDiagnostic test
Following blood collection, the subject will undergo the bronchoscopy for research purposes. While in the operating room, a bronchoscope will be inserted through the breathing tube that is already been placed for the surgery. Subject's airways will be examined with the bronchoscope in both lungs. Ten tablespoons (150 mL) of saline solution will be injected into one of subject airways. The fluid will be re-collected by suctioning it back up with the bronchoscope. The fluid will be collected from the bronchscope.
| Study group | Role | What they receive |
|---|---|---|
| Hiatal Hernia Group | The subject has a history of acid reflux and/or hiatal hernia undergoing surgical repair by thoracic surgery at the University of Virginia. Receives: Diagnostic Test: Blood Collection; Diagnostic Test: Bronchoscopy | |
| Control Group | Patients undergoing bronchoscopy for clinical purposes at the University of Virginia endoscopy suite without a clinical diagnosis of hiatal hernia and/or pulmonary fibrosis. Receives: Diagnostic Test: Blood Collection; Diagnostic Test: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchoalveolar lavage fluid pepsin levels
Investigators examine whether bronchoalveolar lavage fluid levels of pepsin are significantly different by case (adults with hiatal hernia and/or gastroesophageal reflux undergoing surgical repair) and control status (adults without hiatal hernia). Pepsin levels will be measured by ELISA assay.
Measured: Baseline
Secondary outcomes (4)
Serum matrix metalloproteinase-7
Serum matrix metalloproteinase-7 will be measured by ELISA assay.
Measured: Baseline
Serum CA-125
Serum CA-125 will be measured by ELISA assay.
Measured: Baseline
Serum vascular cell adhesion molecule-1
Serum vascular cell adhesion molecule-1 will be measured by ELISA assay.
Measured: Baseline
RNA gene expression
Gene set enrichment analysis (GSEA) will be performed with a false-discovery rate of <5%. GSEA uses a priori sets of genes that have been grouped together by their common biological pathway stored in databases. Genes constituting very high and low expression will be determined by using the R package "GOSim" with a cutoff q-value <0.01. Cell Population Mapping will be used, an algorithm in the R package "scBio", to perform cell composition analysis and determine the relative abundance of cell compositions. Reference RNA-seq dataset from healthy donors with an annotated cell type meta data from the Broad Institute Single Cell Portal will be used.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start5 Jan 2023
- Primary completion31 Mar 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hiatal HerniaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Chest Physicians
- Responsible party
- Principal investigator, John Kim, MD, MS, University of Virginia
- Investigators
- John Kim, MD, Principal investigator, University of VirginiaRoselove Asare, MA, Study director, UVAYousef Althulth, MD, Study director, UVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716022
- Sponsor's protocol ID
- HSR220294
- Status last verified
- Mar 2026
- First submitted
- 18 Jan 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will become available 24 months after completion of study upon request to principal investigator.
Publications
Kim JS, Kim J, Yin X, Hiura GT, Anderson MR, Hoffman EA, Raghu G, Noth I, Manichaikul A, Rich SS, Smith BM, Podolanczuk AJ, Garcia CK, Barr RG, Prince MR, Oelsner EC. Associations of hiatus hernia with CT-based interstitial lung changes: the MESA Lung Study. Eur Respir J. 2023 Jan 27;61(1):2103173. doi: 10.1183/13993003.03173-2021. Print 2023 Jan.
PubMed 35777776Kim JS, Axelsson GT, Moll M, Anderson MR, Bernstein EJ, Putman RK, Hida T, Hatabu H, Hoffman EA, Raghu G, Kawut SM, Doyle MF, Tracy R, Launer LJ, Manichaikul A, Rich SS, Lederer DJ, Gudnason V, Hobbs BD, Cho MH, Hunninghake GM, Garcia CK, Gudmundsson G, Barr RG, Podolanczuk AJ. Associations of Monocyte Count and Other Immune Cell Types with Interstitial Lung Abnormalities. Am J Respir Crit Care Med. 2022 Apr 1;205(7):795-805. doi: 10.1164/rccm.202108-1967OC.
PubMed 34929108Scott MKD, Quinn K, Li Q, Carroll R, Warsinske H, Vallania F, Chen S, Carns MA, Aren K, Sun J, Koloms K, Lee J, Baral J, Kropski J, Zhao H, Herzog E, Martinez FJ, Moore BB, Hinchcliff M, Denny J, Kaminski N, Herazo-Maya JD, Shah NH, Khatri P. Increased monocyte count as a cellular biomarker for poor outcomes in fibrotic diseases: a retrospective, multicentre cohort study. Lancet Respir Med. 2019 Jun;7(6):497-508. doi: 10.1016/S2213-2600(18)30508-3. Epub 2019 Mar 29.
PubMed 30935881Wijsenbeek M, Cottin V. Spectrum of Fibrotic Lung Diseases. N Engl J Med. 2020 Sep 3;383(10):958-968. doi: 10.1056/NEJMra2005230. No abstract available.
PubMed 32877584Lee JS, Song JW, Wolters PJ, Elicker BM, King TE Jr, Kim DS, Collard HR. Bronchoalveolar lavage pepsin in acute exacerbation of idiopathic pulmonary fibrosis. Eur Respir J. 2012 Feb;39(2):352-8. doi: 10.1183/09031936.00050911. Epub 2011 Dec 19.
PubMed 22183478Noth I, Zangan SM, Soares RV, Forsythe A, Demchuk C, Takahashi SM, Patel SB, Strek ME, Krishnan JA, Patti MG, Macmahon H. Prevalence of hiatal hernia by blinded multidetector CT in patients with idiopathic pulmonary fibrosis. Eur Respir J. 2012 Feb;39(2):344-51. doi: 10.1183/09031936.00099910. Epub 2011 Jul 7.
PubMed 21737563
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hiatal Hernia and Pulmonary Involvement Related to Subclinical Lung Injury and Fibrosis
- ClinicalTrials.gov ID
- NCT05716022
- Acronym / sponsor ID
- HSR220294
- Conditions
- Hiatal Hernia, Interstitial Lung Disease
- Keywords
- Hiatal Hernia, BALF, Interstitial lung Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- American College of Chest Physicians
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Feb 2023 (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.
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).
Detailed description
Fibrosing interstitial lung diseases (ILDs) have significant morbidity and poor overall survival as the investigation of earlier stages of fibrosing ILDs may identify modifiable risk factors and elucidate its pathogenesis. Interstitial lung disease (ILD) constitutes a group of chronic respiratory illnesses that are characterized by repetitive injury to the lung parenchyma that may progress to fibrosis. Fibrosing ILDs, which include idiopathic pulmonary fibrosis (IPF) and other ILD types, can lead to chronic respiratory failure, and poor survival, is the most common indication for lung transplantation. While antifibrotics slow disease progression and may reduce mortality, they carry side effects and are frequently poorly tolerated by patients. Therefore, there is a critical need to identify novel therapeutic targets. 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.
Hiatal hernia and its promotion of gastroesophageal reflux have been implicated as a causal risk factor in pulmonary fibrosis. One potential modifiable risk factor is hiatal hernia and its promotion of gastroesophageal reflux (GER). Gastric materials in the lung induce parenchymal injury and fibrosis in pre-clinical models as GER may be a vehicle of repetitive lung injury that is then followed by aberrant wound healing and eventual fibrosis. Hiatal hernia, which is the protrusion of stomach contents in the thoracic cavity, can promote GER and is more prevalent in adults with pulmonary fibrosis compared with healthy controls and other chronic lung diseases. Further evidence comes from studies in which patients with IPF and other fibrosing ILDs (many of whom had a hiatal hernia) demonstrated elevated levels of pepsin in their bronchoalveolar lavage fluid (BALF), a significant component of reflux and measurable biomarker, compared with healthy controls and is associated with a higher risk of exacerbation. Much of these studies have been case-control and performed in adults with clinically-diagnosed fibrosing ILD which limits causal inferences. It has been hypothesized that fibrosis itself may promote GER due to impaired esophageal sphincter function due to reduced elasticity and more negative intrathoracic pressures. Whether hiatal hernia contributes to subclinical repetitive injury to the lung among adults without clinically-diagnosed ILD is a significant knowledge gap.
Overactivation of the mononuclear phagocyte immune system may contribute to developing fibrosing ILDs and their progression. Single-cell RNA sequencing (scRNA-seq) has accelerated our understanding of fibrosing ILD by identifying biological pathways related to certain cellular populations. Using scRNA-seq, our group and others have demonstrated that overactivation of the mononuclear phagocyte system, a key component of the innate immune system, may be critical in the pathogenesis of IPF with higher populations of monocytes found in the lungs and blood of patients with fibrosis. Higher levels of the absolute monocyte count in the blood are associated with disease progression and worse survival among adults with IPF. The investigators have extended these findings to earlier stages of ILD as higher monocyte counts are associated with more ILA and its progression on CT and a lower forced vital capacity. Notably, adults with ILA have more activated monocytes than those without ILA, suggesting a smoldering activation of innate immunity may prime an individual to developing ILD in combination with other risk factors (i.e., smoking, genetic variants, and hiatal hernia).
Radiologically-detected hiatal hernia is associated with a greater burden of CT interstitial lung abnormalities and worse survival among community-dwelling adults. In a population cohort of U.S. community-dwelling adults, investigators found that the presence of hiatal hernia on CT was associated with more HAAs and their progression over time and more ILA among younger adults. Notably, elevated HAAs on CT were associated with worse survival among those with a hiatal hernia compared with those without a hernia. Our findings suggest that hiatal hernia and its promotion of GER may contribute to subclinical injury and remodeling detected by imaging biomarkers. Whether subclinical abnormalities are detected in the lungs of adults with hiatal hernia remains a major knowledge gap that this study will address by examining BALF contents of adults with hiatal hernia.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hiatal Hernia Group | – | Diagnostic Test: Blood Collection, Diagnostic Test: BronchoscopyThe subject has a history of acid reflux and/or hiatal hernia undergoing surgical repair by thoracic surgery at the University of Virginia. |
| Control Group | – | Diagnostic Test: Blood Collection, Diagnostic Test: BronchoscopyPatients undergoing bronchoscopy for clinical purposes at the University of Virginia endoscopy suite without a clinical diagnosis of hiatal hernia and/or pulmonary fibrosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Participants without a clinical diagnosis of pulmonary fibrosis will be recruited from UVA medical center based on the absence of traction bronchiectasis, honeycombing and/or reticular opacities on CT Scan. 2. Case group will be adults who have a clinical diagnosis of hiatal hernia already scheduled to under surgical repair 3. Control group will be adults without a CT diagnosis of hiatal hernia who have been scheduled to undergo Bronchoscopy for lung nodule evaluation.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| Blood CollectionPrior to subject's surgical procedure, blood (about 3 tablespoons (44 mL)) will be collected through a needle in vein for research purposes. The UVA researchers will analyze the biomarkers that are expressed in subject's blood. | Diagnostic test | Control Group, Hiatal Hernia Group |
| BronchoscopyFollowing blood collection, the subject will undergo the bronchoscopy for research purposes. While in the operating room, a bronchoscope will be inserted through the breathing tube that is already been placed for the surgery. Subject's airways will be examined with the bronchoscope in both lungs. Ten tablespoons (150 mL) of saline solution will be injected into one of subject airways. The fluid will be re-collected by suctioning it back up with the bronchoscope. The fluid will be collected from the bronchscope. | Diagnostic test | Control Group, Hiatal Hernia Group |
Primary outcome
Bronchoalveolar lavage fluid pepsin levels
Time frame: Baseline
Investigators examine whether bronchoalveolar lavage fluid levels of pepsin are significantly different by case (adults with hiatal hernia and/or gastroesophageal reflux undergoing surgical repair) and control status (adults without hiatal hernia). Pepsin levels will be measured by ELISA assay.
4 secondary outcomes
Serum matrix metalloproteinase-7
Time frame: Baseline
Serum CA-125
Time frame: Baseline
Serum vascular cell adhesion molecule-1
Time frame: Baseline
RNA gene expression
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 35777776Kim JS, Kim J, Yin X, Hiura GT, Anderson MR, Hoffman EA, Raghu G, Noth I, Manichaikul A, Rich SS, Smith BM, Podolanczuk AJ, Garcia CK, Barr RG, Prince MR, Oelsner EC. Associations of hiatus hernia with CT-based interstitial lung changes: the MESA Lung Study. Eur Respir J. 2023 Jan 27;61(1):2103173. doi: 10.1183/13993003.03173-2021. Print 2023 Jan.
- Background: PubMed 34929108Kim JS, Axelsson GT, Moll M, Anderson MR, Bernstein EJ, Putman RK, Hida T, Hatabu H, Hoffman EA, Raghu G, Kawut SM, Doyle MF, Tracy R, Launer LJ, Manichaikul A, Rich SS, Lederer DJ, Gudnason V, Hobbs BD, Cho MH, Hunninghake GM, Garcia CK, Gudmundsson G, Barr RG, Podolanczuk AJ. Associations of Monocyte Count and Other Immune Cell Types with Interstitial Lung Abnormalities. Am J Respir Crit Care Med. 2022 Apr 1;205(7):795-805. doi: 10.1164/rccm.202108-1967OC.
- Background: PubMed 30935881Scott MKD, Quinn K, Li Q, Carroll R, Warsinske H, Vallania F, Chen S, Carns MA, Aren K, Sun J, Koloms K, Lee J, Baral J, Kropski J, Zhao H, Herzog E, Martinez FJ, Moore BB, Hinchcliff M, Denny J, Kaminski N, Herazo-Maya JD, Shah NH, Khatri P. Increased monocyte count as a cellular biomarker for poor outcomes in fibrotic diseases: a retrospective, multicentre cohort study. Lancet Respir Med. 2019 Jun;7(6):497-508. doi: 10.1016/S2213-2600(18)30508-3. Epub 2019 Mar 29.
- Background: PubMed 32877584Wijsenbeek M, Cottin V. Spectrum of Fibrotic Lung Diseases. N Engl J Med. 2020 Sep 3;383(10):958-968. doi: 10.1056/NEJMra2005230. No abstract available.
- Background: PubMed 22183478Lee JS, Song JW, Wolters PJ, Elicker BM, King TE Jr, Kim DS, Collard HR. Bronchoalveolar lavage pepsin in acute exacerbation of idiopathic pulmonary fibrosis. Eur Respir J. 2012 Feb;39(2):352-8. doi: 10.1183/09031936.00050911. Epub 2011 Dec 19.
- Background: PubMed 21737563Noth I, Zangan SM, Soares RV, Forsythe A, Demchuk C, Takahashi SM, Patel SB, Strek ME, Krishnan JA, Patti MG, Macmahon H. Prevalence of hiatal hernia by blinded multidetector CT in patients with idiopathic pulmonary fibrosis. Eur Respir J. 2012 Feb;39(2):344-51. doi: 10.1183/09031936.00099910. Epub 2011 Jul 7.
- Individual participant dataSharing planned: Yes. Will become available 24 months after completion of study upon request to principal investigator.
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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. This study is not recruiting at the moment.
John Kim, MD principal investigator
University of Virginia
Roselove Asare, MA study director
UVA
Yousef Althulth, MD study director
UVA
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 Hiatal Hernia and Interstitial Lung Disease, run by University of Virginia 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchoalveolar lavage fluid pepsin levels (time frame: Baseline). 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 NCT05716022, which also lists 6 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 16 Mar 2026.