Atrial FibrillationNCT04766814
Epigenetic Analysis of Regulation of the Inflammasome-activating NLRP3 Gene in Monocytes From Atrial Fibrillation Patients and Controls
An observational study of Atrial Fibrillation and Arrhythmia, run by Tulane University at 1 site in United States.
Trial summary
The study will analyze blood from volunteers to determine whether there is an underlying epigenetic cause of the inflammation of the heart associated with atrial fibrillation (AF) and its progression with age. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Arrhythmia
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2021to 16 Feb 2024
- 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 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the Tulane University Cardiology Clinics. The control healthy women subjects will be those scheduled for routine annual health check-up and healthy blood donors without any documentation of cardiovascular disease or other serious immune-related illnesses, such as diabetes, hypertension, autoimmune arthritis etc. The patient population will include women subjects between the ages 50 to 80 years diagnosed with AF as evidenced by rhythm strips or written documentation. Recruitment will also be done using volunteer research registries.
Who may be able to join
- Subjects aged 18 or above,
- Control Group scheduled for routine annual health check-up and healthy blood donors without any documentation of cardiovascular disease or other serious immune-related illnesses, such as diabetes, hypertension, autoimmune arthritis etc
- healthy women subjects between the ages of 50-80 years
- healthy women subjects between the ages of 20-30 years.
- Study Patients -women between the ages of 50 - 80 years diagnosed with AF as evidenced by rhythm strips or written documentation.
Who cannot join
- Previous left atrial ablation or any type of valvular surgery
- Patients who are taking medications like Ibuprofen, Toradol, Naproxen and other common over-the -counter NSAIDs.
- Women who are pregnant
- Terminally ill patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University Medical Center
New Orleans, Louisiana, 70112
About this study
The study will analyze blood from volunteers to determine whether there is an underlying epigenetic cause of the inflammation of the heart associated with atrial fibrillation (AF) and its progression with age. Confirming the regions of epigenetic elements associated with upregulation of the inflammatory genes will help the investigators in identifying target sites for developing future therapeutic interventions. The investigators propose to confirm the monocyte-cell type specific DNA methylation profile of NOD-, LRR- and pyrin domain-containing protein 3 (NLRP3) and determine the age-related and AF-related changes in DNA methylation and expression of NLRP3 in monocytes. This study will provide insights into the epigenetic regulation of NLRP3 in young and elderly patients, as well as in AF patients vs. controls which will help in devising methods of modulating NLRP3 expression and decreasing cardiac fibrosis progression.
Read the detailed description
Blood samples will be collected from 30 female participants as follows: 10 women between the ages of 50 - 80 years diagnosed with AF as evidenced by rhythm strips or written documentation; 10 healthy women subjects between the ages of 50-80 years and 10 healthy women between the ages of 20-30 years.
Participants will be recruited from the Tulane University Cardiology Clinics and also from volunteer research registries. These participants will be asked for consent to draw for another 8 ml (1.5 teaspoons) of blood during routine diagnostic blood draws. These blood samples will be de-identified by the PI upon receipt and no identifiable information will be maintained. Leukocyte subtypes including monocytes, neutrophils and B cells will be isolated from blood and DNA extraction will be carried out from the leukocyte subtypes. These leukocyte DNA samples will be sent to New England Biolabs, Ipswich, Massachusetts for DNA methylation analysis to identify target regions of epigenetic elements associated with upregulation of NLRP3 gene expression that might be related to disease progression with age. Real-Time Polymerase chain reaction (PCR) will be carried out at Tulane Research and Innovation for Arrhythmia Discoveries (TRIAD) Center, Tulane University School of Medicine from RNA extracted from leukocyte subtype to check the level of expression of NLRP3 highly associated with inflammation in AF.
- Conditions
- Atrial Fibrillation, Arrhythmia
- Keywords
- Inflammation, Stroke, DNA methylation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Inflammation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | 10 women between the ages of 50 - 80 years diagnosed with AF as evidenced by rhythm strips or written documentation. | |
| Control Group 1 | 10 healthy women subjects between the ages of 50-80 year | |
| Control Group 2 | 10 healthy women subjects between the ages of 20-30 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether there is an underlying epigenetic cause of the inflammation of the heart associated with atrial fibrillation
This will be determined by confirming the monocyte-cell type specific DNA methylation profile of NLRP3.
Measured: Day 1
Determine whether there are significant associations of DNA methylation with NLRP3 expression in monocytes with advancing age.
Age association will be examined by comparing group wise the DNA methylation levels of monocytes from young vs. old individuals. The level of NLRP3 expression will be compared to the levels of DNA methylation.
Measured: Day 1
Determine whether there are significant associations of DNA methylation with NLRP3 expression in monocytes with the status of atrial fibrillation.
Disease associations will be tested by comparing group wise the DNA methylation levels of monocytes from AF patients vs. controls. The investigators will also test for understanding significant association of NLRP3 expression with corresponding DNA methylation status in AF patients.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start22 Oct 2021
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana Clinical and Translational Science (LA CaTS) Center Clinical Research Resources Core
- Responsible party
- Sponsor
- Investigators
- Sruti Chandra, PhD, Principal investigator, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766814
- Sponsor's protocol ID
- 2020-561
- Status last verified
- Apr 2024
- First submitted
- 8 Feb 2021
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.
PubMed 24345399Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, Seward JB, Tsang TS. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006 Jul 11;114(2):119-25. doi: 10.1161/CIRCULATIONAHA.105.595140. Epub 2006 Jul 3.
PubMed 16818816Akoum N, Mahnkopf C, Kholmovski EG, Brachmann J, Marrouche NF. Age and sex differences in atrial fibrosis among patients with atrial fibrillation. Europace. 2018 Jul 1;20(7):1086-1092. doi: 10.1093/europace/eux260.
PubMed 29016990Wagstaff AJ, Overvad TF, Lip GY, Lane DA. Is female sex a risk factor for stroke and thromboembolism in patients with atrial fibrillation? A systematic review and meta-analysis. QJM. 2014 Dec;107(12):955-67. doi: 10.1093/qjmed/hcu054. Epub 2014 Mar 14.
PubMed 24633256Emdin CA, Wong CX, Hsiao AJ, Altman DG, Peters SA, Woodward M, Odutayo AA. Atrial fibrillation as risk factor for cardiovascular disease and death in women compared with men: systematic review and meta-analysis of cohort studies. BMJ. 2016 Jan 19;532:h7013. doi: 10.1136/bmj.h7013.
PubMed 26786546Engelmann MD, Svendsen JH. Inflammation in the genesis and perpetuation of atrial fibrillation. Eur Heart J. 2005 Oct;26(20):2083-92. doi: 10.1093/eurheartj/ehi350. Epub 2005 Jun 23.
PubMed 15975993Hohmann C, Pfister R, Mollenhauer M, Adler C, Kozlowski J, Wodarz A, Drebber U, Wippermann J, Michels G. Inflammatory cell infiltration in left atrial appendageal tissues of patients with atrial fibrillation and sinus rhythm. Sci Rep. 2020 Feb 3;10(1):1685. doi: 10.1038/s41598-020-58797-8.
PubMed 32015492Liu Y, Shi Q, Ma Y, Liu Q. The role of immune cells in atrial fibrillation. J Mol Cell Cardiol. 2018 Oct;123:198-208. doi: 10.1016/j.yjmcc.2018.09.007. Epub 2018 Sep 26.
PubMed 30267749Le Jemtel TH, Samson R, Ayinapudi K, Singh T, Oparil S. Epicardial Adipose Tissue and Cardiovascular Disease. Curr Hypertens Rep. 2019 Apr 5;21(5):36. doi: 10.1007/s11906-019-0939-6.
PubMed 30953236Yamashita T, Sekiguchi A, Iwasaki YK, Date T, Sagara K, Tanabe H, Suma H, Sawada H, Aizawa T. Recruitment of immune cells across atrial endocardium in human atrial fibrillation. Circ J. 2010 Feb;74(2):262-70. doi: 10.1253/circj.cj-09-0644. Epub 2009 Dec 15.
PubMed 20009387Shantsila E, Tapp LD, Wrigley BJ, Pamukcu B, Apostolakis S, Montoro-Garcia S, Lip GY. Monocyte subsets in coronary artery disease and their associations with markers of inflammation and fibrinolysis. Atherosclerosis. 2014 May;234(1):4-10. doi: 10.1016/j.atherosclerosis.2014.02.009. Epub 2014 Feb 20.
PubMed 24583499Budai MM, Varga A, Milesz S, Tozser J, Benko S. Aloe vera downregulates LPS-induced inflammatory cytokine production and expression of NLRP3 inflammasome in human macrophages. Mol Immunol. 2013 Dec;56(4):471-9. doi: 10.1016/j.molimm.2013.05.005. Epub 2013 Aug 1.
PubMed 23911403He G, Tan W, Wang B, Chen J, Li G, Zhu S, Xie J, Xu B. Increased M1 Macrophages Infiltration Is Associated with Thrombogenesis in Rheumatic Mitral Stenosis Patients with Atrial Fibrillation. PLoS One. 2016 Mar 1;11(3):e0149910. doi: 10.1371/journal.pone.0149910. eCollection 2016.
PubMed 26930272Mazurek T, Zhang L, Zalewski A, Mannion JD, Diehl JT, Arafat H, Sarov-Blat L, O'Brien S, Keiper EA, Johnson AG, Martin J, Goldstein BJ, Shi Y. Human epicardial adipose tissue is a source of inflammatory mediators. Circulation. 2003 Nov 18;108(20):2460-6. doi: 10.1161/01.CIR.0000099542.57313.C5. Epub 2003 Oct 27.
PubMed 14581396Nattel S. Molecular and Cellular Mechanisms of Atrial Fibrosis in Atrial Fibrillation. JACC Clin Electrophysiol. 2017 May;3(5):425-435. doi: 10.1016/j.jacep.2017.03.002. Epub 2017 May 15.
PubMed 29759598
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Analysis of Regulation of the Inflammasome-activating NLRP3 Gene in Monocytes From Atrial Fibrillation Patients and Controls
- ClinicalTrials.gov ID
- NCT04766814
- Acronym / sponsor ID
- 2020-561
- Conditions
- Atrial Fibrillation, Arrhythmia
- Keywords
- Inflammation, Stroke, DNA methylation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Louisiana Clinical and Translational Science (LA CaTS) Center Clinical Research Resources Core
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 23 Feb 2021 (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.
The study will analyze blood from volunteers to determine whether there is an underlying epigenetic cause of the inflammation of the heart associated with atrial fibrillation (AF) and its progression with age. Confirming the regions of epigenetic elements associated with upregulation of the inflammatory genes will help the investigators in identifying target sites for developing future therapeutic interventions. The investigators propose to confirm the monocyte-cell type specific DNA methylation profile of NOD-, LRR- and pyrin domain-containing protein 3 (NLRP3) and determine the age-related and AF-related changes in DNA methylation and expression of NLRP3 in monocytes. This study will provide insights into the epigenetic regulation of NLRP3 in young and elderly patients, as well as in AF patients vs. controls which will help in devising methods of modulating NLRP3 expression and decreasing cardiac fibrosis progression.
Detailed description
Blood samples will be collected from 30 female participants as follows: 10 women between the ages of 50 - 80 years diagnosed with AF as evidenced by rhythm strips or written documentation; 10 healthy women subjects between the ages of 50-80 years and 10 healthy women between the ages of 20-30 years.
Participants will be recruited from the Tulane University Cardiology Clinics and also from volunteer research registries. These participants will be asked for consent to draw for another 8 ml (1.5 teaspoons) of blood during routine diagnostic blood draws. These blood samples will be de-identified by the PI upon receipt and no identifiable information will be maintained. Leukocyte subtypes including monocytes, neutrophils and B cells will be isolated from blood and DNA extraction will be carried out from the leukocyte subtypes. These leukocyte DNA samples will be sent to New England Biolabs, Ipswich, Massachusetts for DNA methylation analysis to identify target regions of epigenetic elements associated with upregulation of NLRP3 gene expression that might be related to disease progression with age. Real-Time Polymerase chain reaction (PCR) will be carried out at Tulane Research and Innovation for Arrhythmia Discoveries (TRIAD) Center, Tulane University School of Medicine from RNA extracted from leukocyte subtype to check the level of expression of NLRP3 highly associated with inflammation in AF.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | –10 women between the ages of 50 - 80 years diagnosed with AF as evidenced by rhythm strips or written documentation. |
| Control Group 1 | – | –10 healthy women subjects between the ages of 50-80 year |
| Control Group 2 | – | –10 healthy women subjects between the ages of 20-30 years |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the Tulane University Cardiology Clinics. The control healthy women subjects will be those scheduled for routine annual health check-up and healthy blood donors without any documentation of cardiovascular disease or other serious immune-related illnesses, such as diabetes, hypertension, autoimmune arthritis etc. The patient population will include women subjects between the ages 50 to 80 years diagnosed with AF as evidenced by rhythm strips or written documentation. Recruitment will also be done using volunteer research registries.
Key inclusion criteria (5 listed)
- Subjects aged 18 or above,
- Control Group scheduled for routine annual health check-up and healthy blood donors without any documentation of cardiovascular disease or other serious immune-related illnesses, such as diabetes, hypertension, autoimmune arthritis etc
- Study Patients -women between the ages of 50 - 80 years diagnosed with AF as evidenced by rhythm strips or written documentation.
Key exclusion criteria (4 listed)
- Previous left atrial ablation or any type of valvular surgery
- Patients who are taking medications like Ibuprofen, Toradol, Naproxen and other common over-the -counter NSAIDs.
- Women who are pregnant
- Terminally ill patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine whether there is an underlying epigenetic cause of the inflammation of the heart associated with atrial fibrillation
Time frame: Day 1
This will be determined by confirming the monocyte-cell type specific DNA methylation profile of NLRP3.
Determine whether there are significant associations of DNA methylation with NLRP3 expression in monocytes with advancing age.
Time frame: Day 1
Age association will be examined by comparing group wise the DNA methylation levels of monocytes from young vs. old individuals. The level of NLRP3 expression will be compared to the levels of DNA methylation.
Determine whether there are significant associations of DNA methylation with NLRP3 expression in monocytes with the status of atrial fibrillation.
Time frame: Day 1
Disease associations will be tested by comparing group wise the DNA methylation levels of monocytes from AF patients vs. controls. The investigators will also test for understanding significant association of NLRP3 expression with corresponding DNA methylation status in AF patients.
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 25 Apr 2024.
- Background: PubMed 24345399Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.
- Background: PubMed 16818816Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, Seward JB, Tsang TS. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006 Jul 11;114(2):119-25. doi: 10.1161/CIRCULATIONAHA.105.595140. Epub 2006 Jul 3.
- Background: PubMed 29016990Akoum N, Mahnkopf C, Kholmovski EG, Brachmann J, Marrouche NF. Age and sex differences in atrial fibrosis among patients with atrial fibrillation. Europace. 2018 Jul 1;20(7):1086-1092. doi: 10.1093/europace/eux260.
- Background: PubMed 24633256Wagstaff AJ, Overvad TF, Lip GY, Lane DA. Is female sex a risk factor for stroke and thromboembolism in patients with atrial fibrillation? A systematic review and meta-analysis. QJM. 2014 Dec;107(12):955-67. doi: 10.1093/qjmed/hcu054. Epub 2014 Mar 14.
- Background: PubMed 26786546Emdin CA, Wong CX, Hsiao AJ, Altman DG, Peters SA, Woodward M, Odutayo AA. Atrial fibrillation as risk factor for cardiovascular disease and death in women compared with men: systematic review and meta-analysis of cohort studies. BMJ. 2016 Jan 19;532:h7013. doi: 10.1136/bmj.h7013.
- Background: PubMed 15975993Engelmann MD, Svendsen JH. Inflammation in the genesis and perpetuation of atrial fibrillation. Eur Heart J. 2005 Oct;26(20):2083-92. doi: 10.1093/eurheartj/ehi350. Epub 2005 Jun 23.
- Background: PubMed 32015492Hohmann C, Pfister R, Mollenhauer M, Adler C, Kozlowski J, Wodarz A, Drebber U, Wippermann J, Michels G. Inflammatory cell infiltration in left atrial appendageal tissues of patients with atrial fibrillation and sinus rhythm. Sci Rep. 2020 Feb 3;10(1):1685. doi: 10.1038/s41598-020-58797-8.
- Background: PubMed 30267749Liu Y, Shi Q, Ma Y, Liu Q. The role of immune cells in atrial fibrillation. J Mol Cell Cardiol. 2018 Oct;123:198-208. doi: 10.1016/j.yjmcc.2018.09.007. Epub 2018 Sep 26.
- Background: PubMed 30953236Le Jemtel TH, Samson R, Ayinapudi K, Singh T, Oparil S. Epicardial Adipose Tissue and Cardiovascular Disease. Curr Hypertens Rep. 2019 Apr 5;21(5):36. doi: 10.1007/s11906-019-0939-6.
- Background: PubMed 20009387Yamashita T, Sekiguchi A, Iwasaki YK, Date T, Sagara K, Tanabe H, Suma H, Sawada H, Aizawa T. Recruitment of immune cells across atrial endocardium in human atrial fibrillation. Circ J. 2010 Feb;74(2):262-70. doi: 10.1253/circj.cj-09-0644. Epub 2009 Dec 15.
- Background: PubMed 24583499Shantsila E, Tapp LD, Wrigley BJ, Pamukcu B, Apostolakis S, Montoro-Garcia S, Lip GY. Monocyte subsets in coronary artery disease and their associations with markers of inflammation and fibrinolysis. Atherosclerosis. 2014 May;234(1):4-10. doi: 10.1016/j.atherosclerosis.2014.02.009. Epub 2014 Feb 20.
- Background: PubMed 23911403Budai MM, Varga A, Milesz S, Tozser J, Benko S. Aloe vera downregulates LPS-induced inflammatory cytokine production and expression of NLRP3 inflammasome in human macrophages. Mol Immunol. 2013 Dec;56(4):471-9. doi: 10.1016/j.molimm.2013.05.005. Epub 2013 Aug 1.
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Atrial Fibrillation (AF)
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.
Sruti Chandra, PhD principal investigator
Tulane University School of Medicine
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 Atrial Fibrillation and Arrhythmia, run by Tulane University 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 5 inclusion and 4 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 25 Apr 2024. 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?
Determine whether there is an underlying epigenetic cause of the inflammation of the heart associated with atrial fibrillation (time frame: Day 1). The study lists 3 primary outcomes in all. 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 NCT04766814, which also lists 25 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 25 Apr 2024.