Hypertension, PulmonaryLevosim-PHNCT04599816
Levosimendan Administration in Pulmonary Hypertension
A study testing levosimendan at a dose of 3 mcg/kg, levosimendan at a dose of 6 mcg/kg and levosimendan at a dose of 12 mcg/kg in people with Hypertension, Pulmonary and Cardiac Failure, run by Aretaieion University Hospital at 1 site in Greece.
Trial summary
The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Pulmonary, Cardiac Failure, Pulmonary Vascular Resistance Abnormality
- What is being tested?
- levosimendan at a dose of 3 mcg/kg, levosimendan at a dose of 6 mcg/kg and levosimendan at a dose of 12 mcg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGreece
- Study dates
- 17 Oct 2020to 17 Oct 2022
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with pulmonary hypertension due to left ventricular dysfunction based on echocardiographic diagnosis preoperatively
- elective cardiac surgery
Who cannot join
- primary pulmonary hypertension
- thromboembolic disease
- chronic obstructive pulmonary disease
- emergency surgery
- redo surgery
- inability to consent to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levosimendan Administration in High Risk Cardiac Surgery Patients With Pulmonary Hypertension
The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function.
Read the detailed description
Pulmonary hypertension (PH) is a pathophysiological disorder hemodynamically characterized by increased pulmonary vascular resistance and pressure. This can lead to right ventricle pressure overload and failure which is worsened by cardiopulmonary bypass (CPB) and extracorporeal circulation and is accompanied by high rates of morbidity and mortality in cardiac surgery patients. Pharmacological agents used to decrease pulmonary vascular resistance and right ventricle afterload are prostaglandins, iloprost, milrinone, nitric oxide (NO) and recently Levosimendan. These agents can be administered intravenously or via inhalation.
In this study, Levosimendan will be administered in patients with pulmonary hypertension undergoing cardiac surgery. The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function. The drug will be administered in different doses to define the dose at which Levosimendan administration reduces pulmonary vascular resistance and pressure without causing significant reduction of systemic vascular resistance and pressure. The anti-inflammatory effect of the perioperative use of Levosimendan in cardiac surgery will also be studied.
In this setting, 45 patients with PH caused by left sided heart disease, will be assigned into three groups:
GROUP A: Administration of Levosimendan at a dosage of 3mcg/kg after anesthesia induction.
GROUP B: Administration of Levosimendan at a dosage of 6mcg/kg after anesthesia induction.
GROUP C: Administration of Levosimendan at a dosage of 12mcg/kg after anesthesia induction.
Before and after the administration of the drug, heart function will be evaluated by hemodynamic measurements obtained by the Swan-Ganz catheter. These parameters will be heart rate (HR), blood pressure (BP), mean pulmonary arterial pressure (MPAP), central venous pressure (CVP), cardiac output (CO), pulmonary capillary wedge pressure (PCWP), cardiac index (CI), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR). Transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE) will also be used. The anti-inflammatory action of Levosimendan will also be evaluated by interleukin-6 (IL-6) measurements.
This study will lead to conclusions regarding the effectiveness of Levosimendan administration in the treatment of right heart failure and PH in cardiac surgery patients.
- Being tested
- levosimendan at a dose of 3 mcg/kg, levosimendan at a dose of 6 mcg/kg, levosimendan at a dose of 12 mcg/kg
- Keywords
- pulmonary vascular resistance, pulmonary hypertension, vasodilators, cardiopulmonary bypass
- Medical subject headings
- Hypertension, Pulmonary, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosimendan at a dose of 3 mcg/kgDrug
levosimendan will be administered intravenously at a dose of 3 mcg/kg after anesthesia induction
levosimendan at a dose of 6 mcg/kgDrug
levosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction
levosimendan at a dose of 12 mcg/kgDrug
levosimendan will be administered intravenously at a dose of 12 mcg/kg after anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| levosimendan administration at a dose of 3 mcg/kg after anesthesia induction | Active comparator | levosimendan will be administered at a dose of 3 mcg/kg after anesthesia induction Receives: Drug: levosimendan at a dose of 3 mcg/kg |
| levosimendan administration at a dose of 6 mcg/kg after anesthesia induction | Active comparator | levosimendan will be administered at a dose of 6 mcg/kg after anesthesia induction Receives: Drug: levosimendan at a dose of 6 mcg/kg |
| levosimendan administration at a dose of 12 mcg/kg after anesthesia induction | Active comparator | levosimendan will be administered at a dose of 12 mcg/kg after anesthesia induction Receives: Drug: levosimendan at a dose of 12 mcg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in mean pulmonary arterial pressure (MPAP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
Secondary outcomes (7)
change from baseline in pulmonary vascular resistance (PVR)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in mean arterial pressure (MAP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in systemic vascular resistance (SVR)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in pulmonary capillary wedge pressure (PCWP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in cardiac output (CO)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in tricuspid annular plane systolic excursion (TAPSE)
transthoracic and transesophageal echocardiography will be used for echocardiographic measurements
Measured: 20 minutes after levosimendan administration, at the end of surgery, 2 hours after Intensive Care Unit (ICU) admission and 80 hours after levosimendan administration
change from baseline in fractional area change
transthoracic and transesophageal echocardiography will be used for echocardiographic measurements
Measured: 20 minutes after levosimendan administration, at the end of surgery, 2 hours after Intensive Care Unit (ICU) admission and 80 hours after levosimendan administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start17 Oct 2020
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, PhD, DESA, Principal investigator, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599816
- Sponsor's protocol ID
- annie-panagiotis
- Acronym
- Levosim-PH
- Status last verified
- Feb 2023
- First submitted
- 18 Oct 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Theodoraki K, Rellia P, Thanopoulos A, Tsourelis L, Zarkalis D, Sfyrakis P, Antoniou T. Inhaled iloprost controls pulmonary hypertension after cardiopulmonary bypass. Can J Anaesth. 2002 Nov;49(9):963-7. doi: 10.1007/BF03016884.
PubMed 12419726Theodoraki K, Thanopoulos A, Rellia P, Leontiadis E, Zarkalis D, Perreas K, Antoniou T. A retrospective comparison of inhaled milrinone and iloprost in post-bypass pulmonary hypertension. Heart Vessels. 2017 Dec;32(12):1488-1497. doi: 10.1007/s00380-017-1023-2. Epub 2017 Jul 17.
PubMed 28717881Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92.
PubMed 19151265Hansen MS, Andersen A, Nielsen-Kudsk JE. Levosimendan in pulmonary hypertension and right heart failure. Pulm Circ. 2018 Jul-Sep;8(3):2045894018790905. doi: 10.1177/2045894018790905. Epub 2018 Jul 6.
PubMed 29979110Boost KA, Hoegl S, Dolfen A, Czerwonka H, Scheiermann P, Zwissler B, Hofstetter C. Inhaled levosimendan reduces mortality and release of proinflammatory mediators in a rat model of experimental ventilator-induced lung injury. Crit Care Med. 2008 Jun;36(6):1873-9. doi: 10.1097/CCM.0b013e3181743e63.
PubMed 18496375Kundra TS, Nagaraja PS, Bharathi KS, Kaur P, Manjunatha N. Inhaled levosimendan versus intravenous levosimendan in patients with pulmonary hypertension undergoing mitral valve replacement. Ann Card Anaesth. 2018 Jul-Sep;21(3):328-332. doi: 10.4103/aca.ACA_19_18.
PubMed 30052230Elhassan A, Essandoh M. Inhaled Levosimendan for Pulmonary Hypertension Treatment During Cardiac Surgery: A Novel Application to Avoid Systemic Hypotension. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1169-1170. doi: 10.1053/j.jvca.2018.11.039. Epub 2018 Nov 28. No abstract available.
PubMed 30612930Zhang J, Gage EM, Ji QC, El-Shourbagy TA. A strategy for high-throughput analysis of levosimendan and its metabolites in human plasma samples using sequential negative and positive ionization liquid chromatography/tandem mass spectrometric detection. Rapid Commun Mass Spectrom. 2007;21(14):2169-76. doi: 10.1002/rcm.3046.
PubMed 17631672
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levosimendan Administration in High Risk Cardiac Surgery Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT04599816
- Acronym / sponsor ID
- Levosim-PH / annie-panagiotis
- Keywords
- pulmonary vascular resistance, pulmonary hypertension, vasodilators, cardiopulmonary bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 23 Oct 2020 (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 the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function.
Detailed description
Pulmonary hypertension (PH) is a pathophysiological disorder hemodynamically characterized by increased pulmonary vascular resistance and pressure. This can lead to right ventricle pressure overload and failure which is worsened by cardiopulmonary bypass (CPB) and extracorporeal circulation and is accompanied by high rates of morbidity and mortality in cardiac surgery patients. Pharmacological agents used to decrease pulmonary vascular resistance and right ventricle afterload are prostaglandins, iloprost, milrinone, nitric oxide (NO) and recently Levosimendan. These agents can be administered intravenously or via inhalation.
In this study, Levosimendan will be administered in patients with pulmonary hypertension undergoing cardiac surgery. The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function. The drug will be administered in different doses to define the dose at which Levosimendan administration reduces pulmonary vascular resistance and pressure without causing significant reduction of systemic vascular resistance and pressure. The anti-inflammatory effect of the perioperative use of Levosimendan in cardiac surgery will also be studied.
In this setting, 45 patients with PH caused by left sided heart disease, will be assigned into three groups:
GROUP A: Administration of Levosimendan at a dosage of 3mcg/kg after anesthesia induction.
GROUP B: Administration of Levosimendan at a dosage of 6mcg/kg after anesthesia induction.
GROUP C: Administration of Levosimendan at a dosage of 12mcg/kg after anesthesia induction.
Before and after the administration of the drug, heart function will be evaluated by hemodynamic measurements obtained by the Swan-Ganz catheter. These parameters will be heart rate (HR), blood pressure (BP), mean pulmonary arterial pressure (MPAP), central venous pressure (CVP), cardiac output (CO), pulmonary capillary wedge pressure (PCWP), cardiac index (CI), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR). Transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE) will also be used. The anti-inflammatory action of Levosimendan will also be evaluated by interleukin-6 (IL-6) measurements.
This study will lead to conclusions regarding the effectiveness of Levosimendan administration in the treatment of right heart failure and PH in cardiac surgery patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| levosimendan administration at a dose of 3 mcg/kg after anesthesia induction | Active comparator | Drug: levosimendan at a dose of 3 mcg/kglevosimendan will be administered at a dose of 3 mcg/kg after anesthesia induction |
| levosimendan administration at a dose of 6 mcg/kg after anesthesia induction | Active comparator | Drug: levosimendan at a dose of 6 mcg/kglevosimendan will be administered at a dose of 6 mcg/kg after anesthesia induction |
| levosimendan administration at a dose of 12 mcg/kg after anesthesia induction | Active comparator | Drug: levosimendan at a dose of 12 mcg/kglevosimendan will be administered at a dose of 12 mcg/kg after anesthesia induction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with pulmonary hypertension due to left ventricular dysfunction based on echocardiographic diagnosis preoperatively
- elective cardiac surgery
Key exclusion criteria (6 listed)
- primary pulmonary hypertension
- thromboembolic disease
- chronic obstructive pulmonary disease
- emergency surgery
- redo surgery
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 |
|---|---|---|
| levosimendan at a dose of 3 mcg/kglevosimendan will be administered intravenously at a dose of 3 mcg/kg after anesthesia induction | Drug | levosimendan administration at a dose of 3 mcg/kg after anesthesia induction |
| levosimendan at a dose of 6 mcg/kglevosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction | Drug | levosimendan administration at a dose of 6 mcg/kg after anesthesia induction |
| levosimendan at a dose of 12 mcg/kglevosimendan will be administered intravenously at a dose of 12 mcg/kg after anesthesia induction | Drug | levosimendan administration at a dose of 12 mcg/kg after anesthesia induction |
Primary outcome
change from baseline in mean pulmonary arterial pressure (MPAP)
Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
a Swan-Ganz catheter will be used for hemodynamic measurements
7 secondary outcomes
change from baseline in pulmonary vascular resistance (PVR)
Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in mean arterial pressure (MAP)
Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in systemic vascular resistance (SVR)
Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in pulmonary capillary wedge pressure (PCWP)
Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in cardiac output (CO)
Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in tricuspid annular plane systolic excursion (TAPSE)
Time frame: 20 minutes after levosimendan administration, at the end of surgery, 2 hours after Intensive Care Unit (ICU) admission and 80 hours after levosimendan administration
change from baseline in fractional area change
Time frame: 20 minutes after levosimendan administration, at the end of surgery, 2 hours after Intensive Care Unit (ICU) admission and 80 hours after levosimendan administration
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 8 Feb 2023.
- Background: PubMed 12419726Theodoraki K, Rellia P, Thanopoulos A, Tsourelis L, Zarkalis D, Sfyrakis P, Antoniou T. Inhaled iloprost controls pulmonary hypertension after cardiopulmonary bypass. Can J Anaesth. 2002 Nov;49(9):963-7. doi: 10.1007/BF03016884.
- Background: PubMed 28717881Theodoraki K, Thanopoulos A, Rellia P, Leontiadis E, Zarkalis D, Perreas K, Antoniou T. A retrospective comparison of inhaled milrinone and iloprost in post-bypass pulmonary hypertension. Heart Vessels. 2017 Dec;32(12):1488-1497. doi: 10.1007/s00380-017-1023-2. Epub 2017 Jul 17.
- Background: PubMed 19151265Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92.
- Background: PubMed 29979110Hansen MS, Andersen A, Nielsen-Kudsk JE. Levosimendan in pulmonary hypertension and right heart failure. Pulm Circ. 2018 Jul-Sep;8(3):2045894018790905. doi: 10.1177/2045894018790905. Epub 2018 Jul 6.
- Background: PubMed 18496375Boost KA, Hoegl S, Dolfen A, Czerwonka H, Scheiermann P, Zwissler B, Hofstetter C. Inhaled levosimendan reduces mortality and release of proinflammatory mediators in a rat model of experimental ventilator-induced lung injury. Crit Care Med. 2008 Jun;36(6):1873-9. doi: 10.1097/CCM.0b013e3181743e63.
- Background: PubMed 30052230Kundra TS, Nagaraja PS, Bharathi KS, Kaur P, Manjunatha N. Inhaled levosimendan versus intravenous levosimendan in patients with pulmonary hypertension undergoing mitral valve replacement. Ann Card Anaesth. 2018 Jul-Sep;21(3):328-332. doi: 10.4103/aca.ACA_19_18.
- Background: PubMed 30612930Elhassan A, Essandoh M. Inhaled Levosimendan for Pulmonary Hypertension Treatment During Cardiac Surgery: A Novel Application to Avoid Systemic Hypotension. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1169-1170. doi: 10.1053/j.jvca.2018.11.039. Epub 2018 Nov 28. No abstract available.
- Background: PubMed 17631672Zhang J, Gage EM, Ji QC, El-Shourbagy TA. A strategy for high-throughput analysis of levosimendan and its metabolites in human plasma samples using sequential negative and positive ionization liquid chromatography/tandem mass spectrometric detection. Rapid Commun Mass Spectrom. 2007;21(14):2169-76. doi: 10.1002/rcm.3046.
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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.
Kassiani Theodoraki, PhD, DESA principal investigator
Aretaieion University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levosimendan at a dose of 3 mcg/kg, levosimendan at a dose of 6 mcg/kg and levosimendan at a dose of 12 mcg/kg in people with Hypertension, Pulmonary and Cardiac Failure, run by Aretaieion University Hospital at 1 site in Greece.
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 2 inclusion and 6 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 8 Feb 2023. 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 Greece. 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?
change from baseline in mean pulmonary arterial pressure (MPAP) (time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission). 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 NCT04599816, which also lists 8 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 8 Feb 2023.