Cardiogenic ShockGoldilocsNCT05728359
Genomic Determinants of Outcome in Cardiogenic Shock
An observational study of Cardiogenic Shock, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this project is to understand the heterogeneity of both the immune consequences and treatment responses in CS. We will explore this heterogeneity through identification of transcriptomic sub-phenotypes and their association with outcomes, including therapeutic responses. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Observational study
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Aug 2022to 31 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Adult, Older adult
Study population: All patients presenting to recruiting sites who fulfil study inclusion criteria and have no exclusion, will be considered. The majority of patients will be present through the heart attack centres and pathways. Some patients will, however, develop cardiogenic shock (CS) during their admission. These patients will be recruited from the coronary care units, intensive care units or cardiology wards and will be identified by clinicians who will alert research staff.
Who may be able to join
- All of the following are required for inclusion following screening:
- Willing to provide informed consent or appropriate consent from a nominated consultee or personal consultee
- Presentation within 24 hours of onset of ACS symptoms.
- CS can only be secondary to ACS (Type 1 MI STEMI or N-STEMI) or myocarditis
- Planned or completed revascularisation of culprit coronary artery
- CS will be defined by:
Show all 13Show fewer
- Systolic blood pressure <90 mmHg for at least 30 minutes
- A requirement for a continuous infusion of vasopressor or inotropic therapy to maintain systolic blood pressure > 90 mmHg.
- Clinical signs of pulmonary congestion, plus signs of impaired organ perfusion with at least one of the following manifestations:
- altered mental status.
- cold and clammy skin and limbs.
- oliguria with a urine output of less than 30 ml per hour.
- elevated arterial lactate level of >2.0 mmol per litre.
Who cannot join
- Any of the inclusion criteria not met and:
- Unwilling to provide informed consent.
- Echocardiographic evidence (recorded within 90 mins of end of PCI procedure) of mechanical cause for CS: eg ventricular septal defect, LV-free wall rupture, ischaemic mitral regurgitation.
- Age <18 and ≥80 years.
- Shock from another cause (sepsis, haemorrhagic/hypovolaemic shock, anaphylaxis, etc).
- Significant systemic illness
Show all 13Show fewer
- Known dementia of any severity
- Comorbidity with life expectancy <12 months.
- Out-of-hospital cardiac arrest (OHCA) and any of the following:
- No return of spontaneous circulation (ongoing resuscitation effort)
- pH <7
- Without bystander CPR within 10 minutes of collapse
- Arterial lactate level of <2.0 mmol per litre.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Barts Health NHS trust
London
Dan Jones, dan.jones8@nhs.net
About this study
Official title: Prospective Observational Study Investigating Genomic Determinants of Outcome From Cardiogenic Shock (GOlDilOCS)
The aim of this project is to understand the heterogeneity of both the immune consequences and treatment responses in CS. We will explore this heterogeneity through identification of transcriptomic sub-phenotypes and their association with outcomes, including therapeutic responses.
Read the detailed description
This is a prospective observational cohort study in 8-10 cardiac centres across Europe. We will recruit patients presenting with acute myocardial infarction (AMI) and CS who are supported medically (n=100); with extracorporeal membrane oxygenation (n=50); and with the Impella Device (n=50). We will also enrol patients who present with either AMI and no evidence of CS (n=50) or CS due to non-ischaemic pathologies (e.g. myocarditis: n=50) as comparators. The recruitment target is 300 patients.
- Conditions
- Cardiogenic Shock
- Being tested
- Observational study
- Keywords
- ACS,, Cardiogenic Shock, ECMO, Impella, Gene Expression, Endotype
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Blood sampling and clinical data collection
| Study group | Role | What they receive |
|---|---|---|
| Cardiogenic shock and MI | Patients presenting with acute myocardial infarction and cardiogenic shock who are supported medically (ie. inotropes +/- intra aortic balloon pump only). N=50 Receives: Other: Observational study | |
| Cardiogenic shock and MI wtih ECMO | Patients presenting with acute myocardial infarction and cardiogenic shock who are supported medically with ECMO (+/- LV unloading device). N=50 Receives: Other: Observational study | |
| Cardiogenic shock and MI wtih Impella | Patients presenting with acute myocardial infarction and cardiogenic shock who are supported medically with Impella. N=50 Receives: Other: Observational study | |
| MI without cardiogenic shock | Patients presenting with acute myocardial infarction and cardiogenic shock as a control comparator Receives: Other: Observational study | |
| Non ischemic Cardiogenic Shock ie myocarditis | Patients presenting with myocarditis and cardiogenic shock as a control comparator Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim is to better understand the heterogeneity of the immune consequences and treatment responses in CS through identification of transcriptomic sub-phenotypes and their association with in-hospital mortality
This will be achieved through bloods sample collection, analysis and linked to the patient's clinical diagnosis and outcome.
Measured: through study completion, an average of 5 days
Secondary outcomes (6)
Identify transcriptomic (and chemokine/cytokine) signatures at presentation that elucidate the pathobiology of CS and examine their subsequent evolution.
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
Measured: through study completion, an average of 5 days
Correlate recently identified clinical phenotypes of CS with transcriptomic and inflammatory mediator signatures.
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
Measured: through study completion, an average of 5 days
Identify transcriptomic and chemokine/cytokine signatures at presentation that improve prognostic accuracy in patients with CS
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
Measured: through study completion, an average of 5 days
Investigate inter-individual heterogeneity in the dynamic transcriptomic response to CS through an eQTL mapping approach and identify context- specific regulatory genetic variants involving gene networks central to the pathogenesis of CS.
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
Measured: through study completion, an average of 5 days
Identity novel therapeutic targets that might modulate the dysfunctional immune response to CS - "drug discovery"
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
Measured: through study completion, an average of 5 days
Determine the extent to which the signatures and drivers of a dysfunctional immune response in CS are shared with other critical illness syndromes.
Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.
Measured: through study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start8 Aug 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Alastair Proudfoot, Principal investigator, Barts Heath NHS trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728359
- Sponsor's protocol ID
- 290406
- Acronym
- Goldilocs
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2022
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maslove DM, Tang B, Shankar-Hari M, Lawler PR, Angus DC, Baillie JK, Baron RM, Bauer M, Buchman TG, Calfee CS, Dos Santos CC, Giamarellos-Bourboulis EJ, Gordon AC, Kellum JA, Knight JC, Leligdowicz A, McAuley DF, McLean AS, Menon DK, Meyer NJ, Moldawer LL, Reddy K, Reilly JP, Russell JA, Sevransky JE, Seymour CW, Shapiro NI, Singer M, Summers C, Sweeney TE, Thompson BT, van der Poll T, Venkatesh B, Walley KR, Walsh TS, Ware LB, Wong HR, Zador ZE, Marshall JC. Redefining critical illness. Nat Med. 2022 Jun;28(6):1141-1148. doi: 10.1038/s41591-022-01843-x. Epub 2022 Jun 17.
PubMed 35715504Davenport EE, Burnham KL, Radhakrishnan J, Humburg P, Hutton P, Mills TC, Rautanen A, Gordon AC, Garrard C, Hill AV, Hinds CJ, Knight JC. Genomic landscape of the individual host response and outcomes in sepsis: a prospective cohort study. Lancet Respir Med. 2016 Apr;4(4):259-71. doi: 10.1016/S2213-2600(16)00046-1. Epub 2016 Feb 23.
PubMed 26917434Toma A, Dos Santos C, Burzynska B, Gora M, Kiliszek M, Stickle N, Kirsten H, Kosyakovsky LB, Wang B, van Diepen S, Epelman S, Szekely Y, Marshall JC, Billia F, Lawler PR. Diversity in the Expressed Genomic Host Response to Myocardial Infarction. Circ Res. 2022 Jun 24;131(1):106-108. doi: 10.1161/CIRCRESAHA.121.318391. Epub 2022 May 9. No abstract available.
PubMed 35534922Cano-Gamez K, Burnham KL, Goh C, Allcock A, Malick ZH, Overend L, Kwok A, Smith DA, Peters-Sengers H, Antcliffe D; GAinS Investigators; McKechnie S, Scicluna BP, van der Poll T, Gordon AC, Hinds CJ, Davenport EE, Knight JC, Webster N, Galley H, Taylor J, Hall S, Addison J, Roughton S, Tennant H, Guleri A, Waddington N, Arawwawala D, Durcan J, Short A, Swan K, Williams S, Smolen S, Mitchell-Inwang C, Gordon T, Errington E, Templeton M, Venatesh P, Ward G, McCauley M, Baudouin S, Higham C, Soar J, Grier S, Hall E, Brett S, Kitson D, Wilson R, Mountford L, Moreno J, Hall P, Hewlett J, McKechnie S, Garrard C, Millo J, Young D, Hutton P, Parsons P, Smiths A, Faras-Arraya R, Soar J, Raymode P, Thompson J, Bowrey S, Kazembe S, Rich N, Andreou P, Hales D, Roberts E, Fletcher S, Rosbergen M, Glister G, Cuesta JM, Bion J, Millar J, Perry EJ, Willis H, Mitchell N, Ruel S, Carrera R, Wilde J, Nilson A, Lees S, Kapila A, Jacques N, Atkinson J, Brown A, Prowse H, Krige A, Bland M, Bullock L, Harrison D, Mills G, Humphreys J, Armitage K, Laha S, Baldwin J, Walsh A, Doherty N, Drage S, Ortiz-Ruiz de Gordoa L, Lowes S, Higham C, Walsh H, Calder V, Swan C, Payne H, Higgins D, Andrews S, Mappleback S, Hind C, Garrard C, Watson D, McLees E, Purdy A, Stotz M, Ochelli-Okpue A, Bonner S, Whitehead I, Hugil K, Goodridge V, Cawthor L, Kuper M, Pahary S, Bellingan G, Marshall R, Montgomery H, Ryu JH, Bercades G, Boluda S, Bentley A, Mccalman K, Jefferies F, Knight J, Davenport E, Burnham K, Maugeri N, Radhakrishnan J, Mi Y, Allcock A, Goh C. An immune dysfunction score for stratification of patients with acute infection based on whole-blood gene expression. Sci Transl Med. 2022 Nov 2;14(669):eabq4433. doi: 10.1126/scitranslmed.abq4433. Epub 2022 Nov 2.
PubMed 36322631
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Investigating Genomic Determinants of Outcome From Cardiogenic Shock (GOlDilOCS)
- ClinicalTrials.gov ID
- NCT05728359
- Acronym / sponsor ID
- Goldilocs / 290406
- Conditions
- Cardiogenic Shock
- Keywords
- ACS,, Cardiogenic Shock, ECMO, Impella, Gene Expression, Endotype
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 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.
The aim of this project is to understand the heterogeneity of both the immune consequences and treatment responses in CS. We will explore this heterogeneity through identification of transcriptomic sub-phenotypes and their association with outcomes, including therapeutic responses.
Detailed description
This is a prospective observational cohort study in 8-10 cardiac centres across Europe. We will recruit patients presenting with acute myocardial infarction (AMI) and CS who are supported medically (n=100); with extracorporeal membrane oxygenation (n=50); and with the Impella Device (n=50). We will also enrol patients who present with either AMI and no evidence of CS (n=50) or CS due to non-ischaemic pathologies (e.g. myocarditis: n=50) as comparators. The recruitment target is 300 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cardiogenic shock and MI | – | Other: Observational studyPatients presenting with acute myocardial infarction and cardiogenic shock who are supported medically (ie. inotropes +/- intra aortic balloon pump only). N=50 |
| Cardiogenic shock and MI wtih ECMO | – | Other: Observational studyPatients presenting with acute myocardial infarction and cardiogenic shock who are supported medically with ECMO (+/- LV unloading device). N=50 |
| Cardiogenic shock and MI wtih Impella | – | Other: Observational studyPatients presenting with acute myocardial infarction and cardiogenic shock who are supported medically with Impella. N=50 |
| MI without cardiogenic shock | – | Other: Observational studyPatients presenting with acute myocardial infarction and cardiogenic shock as a control comparator |
| Non ischemic Cardiogenic Shock ie myocarditis | – | Other: Observational studyPatients presenting with myocarditis and cardiogenic shock as a control comparator |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to recruiting sites who fulfil study inclusion criteria and have no exclusion, will be considered. The majority of patients will be present through the heart attack centres and pathways. Some patients will, however, develop cardiogenic shock (CS) during their admission. These patients will be recruited from the coronary care units, intensive care units or cardiology wards and will be identified by clinicians who will alert research staff.
Key inclusion criteria (13 listed)
- All of the following are required for inclusion following screening:
- Systolic blood pressure <90 mmHg for at least 30 minutes
- A requirement for a continuous infusion of vasopressor or inotropic therapy to maintain systolic blood pressure > 90 mmHg.
- Clinical signs of pulmonary congestion, plus signs of impaired organ perfusion with at least one of the following manifestations:
Key exclusion criteria (13 listed)
- Any of the inclusion criteria not met and:
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 |
|---|---|---|
| Observational studyBlood sampling and clinical data collection | Other | Cardiogenic shock and MI, Cardiogenic shock and MI wtih ECMO, Cardiogenic shock and MI wtih Impella, MI without cardiogenic shock, Non ischemic Cardiogenic Shock ie myocarditis |
Primary outcome
The primary aim is to better understand the heterogeneity of the immune consequences and treatment responses in CS through identification of transcriptomic sub-phenotypes and their association with in-hospital mortality
Time frame: through study completion, an average of 5 days
This will be achieved through bloods sample collection, analysis and linked to the patient's clinical diagnosis and outcome.
6 secondary outcomes
Identify transcriptomic (and chemokine/cytokine) signatures at presentation that elucidate the pathobiology of CS and examine their subsequent evolution.
Time frame: through study completion, an average of 5 days
Correlate recently identified clinical phenotypes of CS with transcriptomic and inflammatory mediator signatures.
Time frame: through study completion, an average of 5 days
Identify transcriptomic and chemokine/cytokine signatures at presentation that improve prognostic accuracy in patients with CS
Time frame: through study completion, an average of 5 days
Investigate inter-individual heterogeneity in the dynamic transcriptomic response to CS through an eQTL mapping approach and identify context- specific regulatory genetic variants involving gene networks central to the pathogenesis of CS.
Time frame: through study completion, an average of 5 days
Identity novel therapeutic targets that might modulate the dysfunctional immune response to CS - "drug discovery"
Time frame: through study completion, an average of 5 days
Determine the extent to which the signatures and drivers of a dysfunctional immune response in CS are shared with other critical illness syndromes.
Time frame: through study completion, an average of 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 35715504Maslove DM, Tang B, Shankar-Hari M, Lawler PR, Angus DC, Baillie JK, Baron RM, Bauer M, Buchman TG, Calfee CS, Dos Santos CC, Giamarellos-Bourboulis EJ, Gordon AC, Kellum JA, Knight JC, Leligdowicz A, McAuley DF, McLean AS, Menon DK, Meyer NJ, Moldawer LL, Reddy K, Reilly JP, Russell JA, Sevransky JE, Seymour CW, Shapiro NI, Singer M, Summers C, Sweeney TE, Thompson BT, van der Poll T, Venkatesh B, Walley KR, Walsh TS, Ware LB, Wong HR, Zador ZE, Marshall JC. Redefining critical illness. Nat Med. 2022 Jun;28(6):1141-1148. doi: 10.1038/s41591-022-01843-x. Epub 2022 Jun 17.
- Background: PubMed 26917434Davenport EE, Burnham KL, Radhakrishnan J, Humburg P, Hutton P, Mills TC, Rautanen A, Gordon AC, Garrard C, Hill AV, Hinds CJ, Knight JC. Genomic landscape of the individual host response and outcomes in sepsis: a prospective cohort study. Lancet Respir Med. 2016 Apr;4(4):259-71. doi: 10.1016/S2213-2600(16)00046-1. Epub 2016 Feb 23.
- Background: PubMed 35534922Toma A, Dos Santos C, Burzynska B, Gora M, Kiliszek M, Stickle N, Kirsten H, Kosyakovsky LB, Wang B, van Diepen S, Epelman S, Szekely Y, Marshall JC, Billia F, Lawler PR. Diversity in the Expressed Genomic Host Response to Myocardial Infarction. Circ Res. 2022 Jun 24;131(1):106-108. doi: 10.1161/CIRCRESAHA.121.318391. Epub 2022 May 9. No abstract available.
- Background: PubMed 36322631Cano-Gamez K, Burnham KL, Goh C, Allcock A, Malick ZH, Overend L, Kwok A, Smith DA, Peters-Sengers H, Antcliffe D; GAinS Investigators; McKechnie S, Scicluna BP, van der Poll T, Gordon AC, Hinds CJ, Davenport EE, Knight JC, Webster N, Galley H, Taylor J, Hall S, Addison J, Roughton S, Tennant H, Guleri A, Waddington N, Arawwawala D, Durcan J, Short A, Swan K, Williams S, Smolen S, Mitchell-Inwang C, Gordon T, Errington E, Templeton M, Venatesh P, Ward G, McCauley M, Baudouin S, Higham C, Soar J, Grier S, Hall E, Brett S, Kitson D, Wilson R, Mountford L, Moreno J, Hall P, Hewlett J, McKechnie S, Garrard C, Millo J, Young D, Hutton P, Parsons P, Smiths A, Faras-Arraya R, Soar J, Raymode P, Thompson J, Bowrey S, Kazembe S, Rich N, Andreou P, Hales D, Roberts E, Fletcher S, Rosbergen M, Glister G, Cuesta JM, Bion J, Millar J, Perry EJ, Willis H, Mitchell N, Ruel S, Carrera R, Wilde J, Nilson A, Lees S, Kapila A, Jacques N, Atkinson J, Brown A, Prowse H, Krige A, Bland M, Bullock L, Harrison D, Mills G, Humphreys J, Armitage K, Laha S, Baldwin J, Walsh A, Doherty N, Drage S, Ortiz-Ruiz de Gordoa L, Lowes S, Higham C, Walsh H, Calder V, Swan C, Payne H, Higgins D, Andrews S, Mappleback S, Hind C, Garrard C, Watson D, McLees E, Purdy A, Stotz M, Ochelli-Okpue A, Bonner S, Whitehead I, Hugil K, Goodridge V, Cawthor L, Kuper M, Pahary S, Bellingan G, Marshall R, Montgomery H, Ryu JH, Bercades G, Boluda S, Bentley A, Mccalman K, Jefferies F, Knight J, Davenport E, Burnham K, Maugeri N, Radhakrishnan J, Mi Y, Allcock A, Goh C. An immune dysfunction score for stratification of patients with acute infection based on whole-blood gene expression. Sci Transl Med. 2022 Nov 2;14(669):eabq4433. doi: 10.1126/scitranslmed.abq4433. Epub 2022 Nov 2.
- Individual participant dataSharing planned: No
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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.
Alastair Proudfoot principal investigator
Barts Heath NHS trust
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 Cardiogenic Shock, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 13 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alastair Proudfoot (02037658707, alastair.proudfoot1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary aim is to better understand the heterogeneity of the immune consequences and treatment responses in CS through identification of transcriptomic sub-phenotypes and their association with in-hospital mortality (time frame: through study completion, an average of 5 days). 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 NCT05728359, which also lists 4 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 18 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.