The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis
2 other identifiers
interventional
12
1 country
1
Brief Summary
The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on the production of inflammatory cytokines that lead to reflux esophagitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
November 16, 2012
CompletedFirst Posted
Study publicly available on registry
November 27, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedFebruary 5, 2020
February 1, 2020
2.5 years
November 16, 2012
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in esophageal inflammation from baseline to 14 days
inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days
day 0 and day 14
Secondary Outcomes (1)
change in HIF-2a levels from baseline to 14 days
day 0 and day 14
Study Arms (1)
Reflux Patients
EXPERIMENTALPatients with reflux and a prior history of reflux esophagitis are being enrolled. The intervention is cessation of acid-suppressing medications.
Interventions
Acid-suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations performed while participant is not on acid-suppressing medications.
Eligibility Criteria
You may qualify if:
- U.S Veteran
- History of Los Angeles Grade C erosive esophagitis
You may not qualify if:
- Inability to provide informed consent
- Esophageal varices
- Warfarin use
- Coagulopathy that precludes safe biopsy of the esophagus
- Comorbidity that precludes safe participation in the study
- Allergy to fluorescein sodium
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Related Publications (2)
Huo X, Agoston AT, Dunbar KB, Cipher DJ, Zhang X, Yu C, Cheng E, Zhang Q, Pham TH, Tambar UK, Bruick RK, Wang DH, Odze RD, Spechler SJ, Souza RF. Hypoxia-inducible factor-2alpha plays a role in mediating oesophagitis in GORD. Gut. 2017 Sep;66(9):1542-1554. doi: 10.1136/gutjnl-2016-312595. Epub 2016 Sep 30.
PMID: 27694141DERIVEDDunbar KB, Agoston AT, Odze RD, Huo X, Pham TH, Cipher DJ, Castell DO, Genta RM, Souza RF, Spechler SJ. Association of Acute Gastroesophageal Reflux Disease With Esophageal Histologic Changes. JAMA. 2016 May 17;315(19):2104-12. doi: 10.1001/jama.2016.5657.
PMID: 27187303DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart J Spechler, MD
Dallas VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
November 16, 2012
First Posted
November 27, 2012
Study Start
February 1, 2013
Primary Completion
July 31, 2015
Study Completion
July 31, 2019
Last Updated
February 5, 2020
Record last verified: 2020-02