Heart FailurePhase 2NCT06522594
REMAP ECMO - Beta Receptor Modulation Trial
A Phase 2 study testing Esmolol in people with Heart Failure and Cardiogenic Shock, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
In this phase 2, single center, randomized clinical pilot trial, investigators will study the effect of a strategy involving a reduction of beta receptor (BR) stimulation (by decreasing dobutamine dosages) and subsequent BR inhibition (through ultra-short acting betablockers), versus a (routine) strategy with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiogenic Shock
- What is being tested?
- Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2024to 3 Dec 2025
- Phase
- Phase 2
- 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
Who may be able to join
- Age ≥ 18 years,
- Having received V-A ECMO support for severe circulatory insufficiency due to left- or bi-ventricular failure.
- ≤ 16 hours after initiation of V-A ECMO support
- Receiving ≥ 2 mcg/kg/min of dobutamine.
- Norepinephrine infusion ≤ 0.4 mcg/kg/min
- Heart rate ≥ 80 bpm (being sinus rhythm, atrial fibrillation or atrial flutter) after V-A ECMO initiation
Who cannot join
- Objection during the deferred consent procedure
- V-A ECMO usage confined to the period during surgery or another intervention (the ECMO was removed at the end of the intervention).
- Concomitant durable Left Ventricular Assist Device (LVAD)
- Polymorphic ventricular tachycardia necessitating BB therapy
- Isolated right ventricular failure (e.g. due to pulmonary embolism)
- Need of high dose dobutamine > 6.0 mcg/kg/min
Show all 18Show fewer
- Epinephrine infusion
- Signs of insufficient trans cardiac flow:
- Absence of aortic valve opening
- Pulse pressure <10 mmHg (with intra-aortic balloon pump (IABP) standby)
- Spontaneous contrast in the heart at echocardiography
- Contraindications for-, intolerance to- or allergy to esmolol
- Second- or third- degree AV block
- Pregnancy
- Life expectancy of less than 24 hours
- Participation in another randomized clinical trial (e.g. On Scene trial or Left Ventricular unloading trial)
- Inability to start study treatment within 4 hours after randomization
- Post heart transplantation patients
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Christiaan L. Meuwese, MD, PhD, 0631135752, c.meuwese@erasmusmc.nl
Myrthe PJ van Steenwijk, MD, 0650162551, m.p.j.vansteenwijk@erasmusmc.nl
About this study
Official title: Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation - Beta Receptor Modulation Trial
In this phase 2, single center, randomized clinical pilot trial, investigators will study the effect of a strategy involving a reduction of beta receptor (BR) stimulation (by decreasing dobutamine dosages) and subsequent BR inhibition (through ultra-short acting betablockers), versus a (routine) strategy with continued BR stimulation through dobutamine infusion, on heart rate in patients with cardiogenic shock due to left- or bi-ventricular failure being supported by V-A ECMO.
Read the detailed description
Despite the great benefits of Venoarterial ExtraCorporeal Membrane Oxygenation (V-A ECMO) and its rapidly increasing usage, even today, 30 till 70 percent of patients cannot be weaned from ECMO support and up to 50 percent of patients will eventually die in the first year. These high incidences of mortality and failure to wean from V-A ECMO support seem largely attributable to failure of the heart to recover in the context of inotropic drug administration and high sympathetic drive due to severe illness (further stressing an already failing heart). As V-A ECMO support creates a "safety window" where organ perfusion no longer relies on native cardiac output, therapeutic focus could be shifted to cardioprotective treatments. Cardioprotective treatments typically include beta blockers (BB) which have unequivocally shown benefits on mortality and morbidity in other patient categories with heart failure with reduced ejection fraction (HFrEF).
The investigators hypothesize that, in selected patients with cardiogenic shock undergoing V-A ECMO support, application of BBs is feasible and safe, and can effectively reduce heart rate.
- Conditions
- Heart Failure, Cardiogenic Shock
- Being tested
- Esmolol
- Keywords
- Veno-Arterial ExtraCorporeal Membrane Oxygenation, Betablocker, Esmolol, Cardiogenic shock
- Medical subject headings
- Heart Failure, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
A vey cardioselective, short-acting betablocker, with an ultra-short half life time.
| Study group | Role | What they receive |
|---|---|---|
| Beta receptor inhibition arm | Experimental | In the "beta receptor (BR) inhibition arm", patients are randomized to a biphasic strategy where BR stimulation is phased out and esmolol (BR blockade) is initiated in a sequential way. During a first phase, milrinone (a phosphodiesterase inhibitor which is routinely used in V-A ECMO supported patients) infusion will be initiated (if not already being given) at 0.25 mcg/kg/min and dobutamine dosages will be decreased every hour and eventually stopped according to the following sequence; 6 - 4 - 2 - 1 - 0 mcg/kg/min.
In a second phase, esmolol is initiated with a dosage of 25 mcg/kg/min. The dose of the BB will be increased with increments of 25 mcg/kg/min every hour until reaching a heart rate between 50 and 70 bpm or a maximum dose of 200 mcg/kg/min. Prior to each dosage escalation, a reassessment of the hemodynamic situation will be done.
The BR inhibition strategy will be continued until 48 hours after randomization or earlier when deemed necessary by the treating physician. Receives: Drug: Esmolol |
| Routine care arm | No intervention | The dosage of dobutamine infusion is at the discretion of the treating physician but is typically continued until 48 hours after randomization. All other medication will be managed according to the needs of the patient at the discretion of the treating physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (delta) in heart rate 24 hours after randomization.
The average heart rate on basis of all observations during 5 minutes at both time points (t=0 and t=24h).
Measured: 24 hours after randomization
Secondary outcomes (21)
Percentage of patients having received esmolol
Measured: after 48 hours
Vasopressor score
using the calculation as described in literature, excluding inotropic medication
Measured: at baseline, 24 and 48 hours
Occurrence of new onset ventricular and/or atrial arrhythmias after randomization
Measured: during the first 48 hours
Left ventricular outflow tract velocity time integral (LVOT VTI)
Echocardiography parameters
Measured: at baseline, 24 and 48 hours
Cardiac output
Pulmonary arterial catheter parameter
Measured: at baseline, 24 and 48 hours
Stroke volume index
Pulmonary arterial catheter parameter
Measured: at baseline, 24 and 48 hours
Pulmonary capillary wedge pressure
Pulmonary arterial catheter parameter
Measured: at baseline, 24 and 48 hours
Central venous pressure
Pulmonary arterial catheter parameter
Measured: at baseline, 24 and 48 hours
Mixed venous oxygen saturation (SvO2)
Pulmonary arterial catheter parameter
Measured: at baseline, 24 and 48 hours
Lactate level
Measured: at baseline, 24 and 48 hours
Troponin
measured at baseline, 24- and 48- hours after randomization, and Area Under the Curve (AUC)
Measured: At 24 and 48 hours after randomization
Myocardial oxygen consumption
Estimated by calculating the pressure volume (PV) area on basis of non-invasive PV loop assessments using echocardiography and pulmonary artery catheter measurements
Measured: At 24 and 48 hours after randomization
Plasma NT-proBNP levels
Biomarker for cardiac stretch
Measured: At baseline and 48 hours after randomization
Plasma Creatine Kinase MB levels
Biomarker for cardiac injury
Measured: At baseline and 48 hours after randomization
FiO2 suppletion
Measured: At 24 and 48 hours after randomization
Plasma metanephrine levels
Measured: At baseline and 24 after randomization
Plasma normetanephrines levels
Measured: At baseline and 24 after randomization
Maximum median dosages of esmolol
Measured: after 48 hours
Ejection fraction (EF)
Echocardiography parameters
Measured: at baseline, 24 and 48 hours
Tricuspid annular plane systolic excursion (TAPSE).
Echocardiography parameters
Measured: at baseline, 24 and 48 hours
Positive End Expiratory Pressure (PEEP) level
Measured: At 24 and 48 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion3 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiaan Meuwese, Erasmus Medical Center
- Investigators
- Christiaan L. Meuwese, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522594
- Sponsor's protocol ID
- EUCT 2024-511805-42
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meuwese CL, Hermens JA, de Haan M, Braithwaite SA, Ramjankhan F, Buijsrogge MP, de Jonge N, Kirkels JH, de Jong M, Pasma W, Vromen-Wijsman JLP, Kraaijeveld AO, de Waal EE, Torn E, Platenkamp M, van der Heijden JJ, Cremer OL, van Dijk D, Donker DW. Twelve years of circulatory extracorporeal life support at the University Medical Centre Utrecht. Neth Heart J. 2021 Jul;29(7-8):394-401. doi: 10.1007/s12471-021-01552-z. Epub 2021 Mar 6.
PubMed 33675521McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992Flather MD, Gollop ND. Understanding Mechanisms of Action of Beta-Blockers in Heart Failure With Reduced and Preserved Ejection Fraction. JACC Heart Fail. 2016 Feb;4(2):150-151. doi: 10.1016/j.jchf.2015.12.009. No abstract available.
PubMed 26823116Rahhal A, Omar AS, Aljundi A, Kasem M, Mahfouz A, Alyafei S. Successful Use of Intravenous B-blocker Therapy in Cardiogenic Shock Supported With Venoarterial Extracorporeal Membrane Oxygenation: A Case Series. Curr Probl Cardiol. 2022 Nov;47(11):101071. doi: 10.1016/j.cpcardiol.2021.101071. Epub 2021 Nov 26.
PubMed 34838902Brugts JJ, Manintveld O, Constantinescu A, Donker DW, van Thiel RJ, Nieman K, Jewbali LS, Zijlstra F, Caliskan K. Preventing LVAD implantation by early short-term mechanical support and prolonged inodilator therapy : A case series with acute refractory cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation and optimised medical strategy. Neth Heart J. 2014 Apr;22(4):176-81. doi: 10.1007/s12471-013-0509-5.
PubMed 24424723
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation - Beta Receptor Modulation Trial
- ClinicalTrials.gov ID
- NCT06522594
- Acronym / sponsor ID
- EUCT 2024-511805-42
- Conditions
- Heart Failure, Cardiogenic Shock
- Keywords
- Veno-Arterial ExtraCorporeal Membrane Oxygenation, Betablocker, Esmolol, Cardiogenic shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 3 Dec 2025 (estimated)
- First posted
- 26 Jul 2024 (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.
In this phase 2, single center, randomized clinical pilot trial, investigators will study the effect of a strategy involving a reduction of beta receptor (BR) stimulation (by decreasing dobutamine dosages) and subsequent BR inhibition (through ultra-short acting betablockers), versus a (routine) strategy with continued BR stimulation through dobutamine infusion, on heart rate in patients with cardiogenic shock due to left- or bi-ventricular failure being supported by V-A ECMO.
Detailed description
Despite the great benefits of Venoarterial ExtraCorporeal Membrane Oxygenation (V-A ECMO) and its rapidly increasing usage, even today, 30 till 70 percent of patients cannot be weaned from ECMO support and up to 50 percent of patients will eventually die in the first year. These high incidences of mortality and failure to wean from V-A ECMO support seem largely attributable to failure of the heart to recover in the context of inotropic drug administration and high sympathetic drive due to severe illness (further stressing an already failing heart). As V-A ECMO support creates a "safety window" where organ perfusion no longer relies on native cardiac output, therapeutic focus could be shifted to cardioprotective treatments. Cardioprotective treatments typically include beta blockers (BB) which have unequivocally shown benefits on mortality and morbidity in other patient categories with heart failure with reduced ejection fraction (HFrEF).
The investigators hypothesize that, in selected patients with cardiogenic shock undergoing V-A ECMO support, application of BBs is feasible and safe, and can effectively reduce heart rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta receptor inhibition arm | Experimental | Drug: EsmololIn the "beta receptor (BR) inhibition arm", patients are randomized to a biphasic strategy where BR stimulation is phased out and esmolol (BR blockade) is initiated in a sequential way. During a first phase, milrinone (a phosphodiesterase inhibitor which is routinely used in V-A ECMO supported patients) infusion will be initiated (if not already being given) at 0.25 mcg/kg/min and dobutamine dosages will be decreased every hour and eventually stopped according to the following sequence; 6 - 4 - 2 - 1 - 0 mcg/kg/min. In a second phase, esmolol is initiated with a dosage of 25 mcg/kg/min. The dose of the BB will be increased with increments of 25 mcg/kg/min every hour until reaching a heart rate between 50 and 70 bpm or a maximum dose of 200 mcg/kg/min. Prior to each dosage escalation, a reassessment of the hemodynamic situation will be done. The BR inhibition strategy will be continued until 48 hours after randomization or earlier when deemed necessary by the treating physician. |
| Routine care arm | No intervention | –The dosage of dobutamine infusion is at the discretion of the treating physician but is typically continued until 48 hours after randomization. All other medication will be managed according to the needs of the patient at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years,
- Having received V-A ECMO support for severe circulatory insufficiency due to left- or bi-ventricular failure.
- ≤ 16 hours after initiation of V-A ECMO support
- Receiving ≥ 2 mcg/kg/min of dobutamine.
- Norepinephrine infusion ≤ 0.4 mcg/kg/min
Key exclusion criteria (18 listed)
- Objection during the deferred consent procedure
- V-A ECMO usage confined to the period during surgery or another intervention (the ECMO was removed at the end of the intervention).
- Concomitant durable Left Ventricular Assist Device (LVAD)
- Polymorphic ventricular tachycardia necessitating BB therapy
- Isolated right ventricular failure (e.g. due to pulmonary embolism)
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 |
|---|---|---|
| EsmololA vey cardioselective, short-acting betablocker, with an ultra-short half life time. | Drug | Beta receptor inhibition arm |
Primary outcome
Change (delta) in heart rate 24 hours after randomization.
Time frame: 24 hours after randomization
The average heart rate on basis of all observations during 5 minutes at both time points (t=0 and t=24h).
21 secondary outcomes
Percentage of patients having received esmolol
Time frame: after 48 hours
Vasopressor score
Time frame: at baseline, 24 and 48 hours
Occurrence of new onset ventricular and/or atrial arrhythmias after randomization
Time frame: during the first 48 hours
Left ventricular outflow tract velocity time integral (LVOT VTI)
Time frame: at baseline, 24 and 48 hours
Cardiac output
Time frame: at baseline, 24 and 48 hours
Stroke volume index
Time frame: at baseline, 24 and 48 hours
Pulmonary capillary wedge pressure
Time frame: at baseline, 24 and 48 hours
Central venous pressure
Time frame: at baseline, 24 and 48 hours
Mixed venous oxygen saturation (SvO2)
Time frame: at baseline, 24 and 48 hours
Lactate level
Time frame: at baseline, 24 and 48 hours
Troponin
Time frame: At 24 and 48 hours after randomization
Myocardial oxygen consumption
Time frame: At 24 and 48 hours after randomization
Plasma NT-proBNP levels
Time frame: At baseline and 48 hours after randomization
Plasma Creatine Kinase MB levels
Time frame: At baseline and 48 hours after randomization
FiO2 suppletion
Time frame: At 24 and 48 hours after randomization
Plasma metanephrine levels
Time frame: At baseline and 24 after randomization
Plasma normetanephrines levels
Time frame: At baseline and 24 after randomization
Maximum median dosages of esmolol
Time frame: after 48 hours
Ejection fraction (EF)
Time frame: at baseline, 24 and 48 hours
Tricuspid annular plane systolic excursion (TAPSE).
Time frame: at baseline, 24 and 48 hours
Positive End Expiratory Pressure (PEEP) level
Time frame: At 24 and 48 hours after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 33675521Meuwese CL, Hermens JA, de Haan M, Braithwaite SA, Ramjankhan F, Buijsrogge MP, de Jonge N, Kirkels JH, de Jong M, Pasma W, Vromen-Wijsman JLP, Kraaijeveld AO, de Waal EE, Torn E, Platenkamp M, van der Heijden JJ, Cremer OL, van Dijk D, Donker DW. Twelve years of circulatory extracorporeal life support at the University Medical Centre Utrecht. Neth Heart J. 2021 Jul;29(7-8):394-401. doi: 10.1007/s12471-021-01552-z. Epub 2021 Mar 6.
- Background: PubMed 34447992McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Background: PubMed 26823116Flather MD, Gollop ND. Understanding Mechanisms of Action of Beta-Blockers in Heart Failure With Reduced and Preserved Ejection Fraction. JACC Heart Fail. 2016 Feb;4(2):150-151. doi: 10.1016/j.jchf.2015.12.009. No abstract available.
- Background: PubMed 34838902Rahhal A, Omar AS, Aljundi A, Kasem M, Mahfouz A, Alyafei S. Successful Use of Intravenous B-blocker Therapy in Cardiogenic Shock Supported With Venoarterial Extracorporeal Membrane Oxygenation: A Case Series. Curr Probl Cardiol. 2022 Nov;47(11):101071. doi: 10.1016/j.cpcardiol.2021.101071. Epub 2021 Nov 26.
- Background: PubMed 24424723Brugts JJ, Manintveld O, Constantinescu A, Donker DW, van Thiel RJ, Nieman K, Jewbali LS, Zijlstra F, Caliskan K. Preventing LVAD implantation by early short-term mechanical support and prolonged inodilator therapy : A case series with acute refractory cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation and optimised medical strategy. Neth Heart J. 2014 Apr;22(4):176-81. doi: 10.1007/s12471-013-0509-5.
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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.
Christiaan L. Meuwese principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esmolol in people with Heart Failure and Cardiogenic Shock, run by Erasmus Medical Center at 1 site in Netherlands.
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 6 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 26 Jul 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 Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christiaan L. Meuwese, MD, PhD (0631135752, c.meuwese@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (delta) in heart rate 24 hours after randomization. (time frame: 24 hours after randomization). 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 NCT06522594, which also lists 5 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 26 Jul 2024.