Acute Myocardial InfarctionPhase 2DOBERMANNNCT05350592
Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock
A Phase 2 study testing Tocilizumab, Dobutamine and NaCl 0.9% in people with Acute Myocardial Infarction and Cardiogenic Shock, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
In the present study, we aim to investigate the effects of dobutamine infusion and/or a single intravenous (IV) dose of the IL-6 antagonist Tocilizumab administered after percutaneous coronary intervention (PCI) to patients with acute myocardial infarction (AMI) presenting < 24 hours from onset of chest pain and an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Cardiogenic Shock
- What is being tested?
- Tocilizumab, Dobutamine and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Mar 2022to 30 Sep 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myocardial infarction
- Revascularization with PCI
- Presentation within 24 hours of chest pain
- ORBI risk score ≥ 10
- Age ≥ 18
Who cannot join
- Unwilling to give informed consent to study participation
- Unable to give consent due to language barrier
- Comatose after cardiac arrest
- Cardiogenic shock with systolic blood pressure < 100 mmHg for more than 30 minutes or need for vasopressor to maintain blood pressure and arterial lactate > 2,5 (2,0) mmol/L developed before leaving the cath. lab.
- Other major clinical non-coronary condition (stroke, sepsis etc.), which can explain a high ORBI risk score
- Referral for acute coronary artery bypass grafting (CABG) (< 24 hours) after the CAG
Show all 13Show fewer
- Contraindications against dobutamine infusion (sustained ventricular tachycardia prior to admission or noted in the cath.lab., known pheochromocytoma, idiopathic hypertrophic subaortic stenosis)
- Tocilizumab allergy
- Pregnant- or breastfeeding women
- Known liver disease/dysfunction
- Ongoing uncontrollable infection
- Immune deficiency/treatment with immunosuppressants
- Known, uncontrolled gastrointestinal (GI) disease predisposing to GI perforation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-dose Dobutamine Infusion and Single-dose Tocilizumab in Acute Myocardial Infarction Patients With High Risk of Cardiogenic Shock Development - a 2x2 Multifactorial, Double-blinded, Randomized, Placebo Controlled Trial
In the present study, we aim to investigate the effects of dobutamine infusion and/or a single intravenous (IV) dose of the IL-6 antagonist Tocilizumab administered after percutaneous coronary intervention (PCI) to patients with acute myocardial infarction (AMI) presenting < 24 hours from onset of chest pain and an intermediate to high risk of cardiogenic shock (CS) by assessment with the ORBI risk score (≥10 - not in overt shock at hospital admission).
Plasma concentrations of pro-B-type natriuretic peptide (proBNP) as a proxy for development of cardiogenic shock (CS) and hemodynamic instability will be sampled for primary endpoint analysis.
Read more
Effects on clinical parameters, mortality, morbidity as well as specific indicators of inflammation, cardiac function, and infarct size will secondarily be assessed noninvasively.
The rationale behind the current study is that inflammatory and neurohormonal responses are associated with subclinical hemodynamic instability in patients with AMI with high risk of CS have worse outcomes. The potentially unstable condition may be targeted pharmacologically as an add-on to existing therapy. This is investigated in patients at elevated risk of CS by sampling biomarkers reflecting the inflammatory and neurohormonal responses, as well as determining effects on patient outcomes and infarct size.
Read the detailed description
The planned study is an investigator-initiated, randomized, double blinded clinical trial.
Consecutive patients at Copenhagen University Hospital, Rigshospitalet admitted with AMI < 24 hours from chest pain will be screened.
Patients eligible for trial inclusion will be randomized 2:2 to receive a continuous IV dobutamine infusion of 5 mcg/kg/minute versus placebo for 24 hours and to receive a single IV dose of tocilizumab (1-hour infusion) versus placebo administered after PCI.
Treatment with the investigational drug will be initiated as soon as possible but no later than 2 hours after transfer to the coronary care unit (CCU) and after informed consent. All included patients will follow usual treatment according to current guidelines.
The biomarker proBNP will be measured in blood samples drawn upon hospital admission in patients with ORBI risk score ≥10, and after 12, 24, 36 and 48 hours from admission.
After treatment termination, 2D-echocardiography will be performed acutely and within 2 days to evaluate left ventricular ejection fraction (LVEF), and cardiac magnetic resonance imaging (cMRi) with late gadolinium enhancement technique prior to hospital discharge as close to 48 hours post-MI and after 3 months after discharge will be performed to calculate area at risk and salvage index after AMI.Blood samples (40 mL) will be obtained and stored in a biobank for subsequent measurement of biomarkers reflecting inflammation, neurohormonal activation, neuronal injury, connective tissue function and other relevant pathophysiological processes.
These biomarkers will solely have research interest and no clinical implications. Furthermore, no genetic biomarkers and markers associated with malignancy development will be measured. Any leftover blood from the research biobank will be transferred to a biobank for future research and stored for up to 10 years solely for research purposes. After this period blood samples will be destroyed.
- Conditions
- Acute Myocardial Infarction, Cardiogenic Shock
- Being tested
- Tocilizumab, Dobutamine, NaCl 0.9%
- Keywords
- acute myocardial infarction, cardiogenic shock, AMI, inflammation, proBNP, AMI-CS, infarct size, STEMI
- Medical subject headings
- Shock, Cardiogenic, Inflammation, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called RoActemra (Actemra)
Single bolus
DobutamineDrug
Also called Dobutrex
Continous weight-adjusted infusion
NaCl 0.9%Drug
Also called Saline isotonic
Placebo comparator and diluent
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab + Dobutamine | Active comparator | Tocilizumab IV 280 mg (100mL/hour, 1 hour) Dobutamine IV 5 micrograms/kg/minute (5mL/hour, 24 hours) Receives: Drug: Tocilizumab; Drug: Dobutamine |
| Tocilizumab + Placebo | Active comparator | Tocilizumab IV 280 mg (100mL/hour, 1 hour) NaCl 0,9% IV (5mL/hour, 24 hours) Receives: Drug: Tocilizumab; Drug: NaCl 0.9% |
| Placebo + Dobutamine | Active comparator | NaCl 0,9% IV (100mL/hour, 1 hour) Dobutamine IV 5 micrograms/kg/minute (5mL/hour, 24 hours) Receives: Drug: Dobutamine; Drug: NaCl 0.9% |
| Placebo + Placebo | Placebo comparator | NaCl 0,9% IV (100mL/hour, 1 hour) NaCl 0,9% IV (5mL/hour, 24 hours) Receives: Drug: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
ProBNP
ProBNP plasma concentration being assessed at multiple time points (including the primary endpoint) will be analyzed by application of a linear mixed model of covariance. As the biomarker will be measured prior to initiation of the study drug, the models will be baseline corrected (i.e., constrained linear mixed models, CLMM). The main result of these analyses will be the treatment-by-time interaction as a marker of whether the proBNP levels change differently over time in the treatment versus the placebo arm.
Measured: 48 hours
Secondary outcomes (13)
CS and/or cardiac arrest
Number of patients developing in-hospital CS and/or in-hospital cardiac arrest
Measured: Index admission
Acute Infarct Size
Magnetic-resonance imaging-estimated infarct size
Measured: Admission
Post-infarction Salvaged Myocardium
Magnetic-resonance imaging-estimated infarct size
Measured: 3 months
Additional biomarkers
Reflecting neurohormonal activation, endothelial function/damage, inflammation (pro- and anti-inflammatory processes - including IL-6 and C-reactive peptide (CRP)), connective tissue damage, organ dysfunction, and other relevant physiological processes
Measured: Index admission
Post-procedure assessment
Survey of PCI operator's post-procedure clinical assessment of the patient's survival at discharge (yes/no)
Measured: Index admission
Development of non-cardiac arrest arrythmia
Number of patients and number of per-patient episodes of sustained ventricular tachycardia or atrial fibrillation with a frequency above 120 for more than 30 minutes
Measured: Index admission
2D echocardiographic measurements of hemodynamics
VTI and left ventricular function including strain measurements according to protocol
Measured: Admisson, 3 months
Re-admission
Number of all cause and cardiovascular admissions during the first year after index hospitalization
Measured: One year
Heart Quality of Life (HeartQoL)
Heart-specific Quality of Life Questionnaire
Measured: Admission, 3 months
EuroQol Group EQ-5D Quality of Life (EQ-5D-5L)
Quality of Life Questionnaire
Measured: Admission, 3 months
HADS (Hospital Anxiety and Depression Scale)
In-patient Anxiety and Depression Questionnaire
Measured: Admission, 3 months
The Montreal Cognitive Assessment (MOCA)
Clinician-administered Cognitive Test
Measured: Admission, 3 months
Clinical Frailty Scale (CFS)
Clinician-administered Assessment
Measured: Admission, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start13 Mar 2022
- Primary completion30 Jun 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Factorial
- Model description
- 2x2
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Simon Spies Fonden, Helge Peetz og Verner Peetz og hustru Vilma Peetz Legat
- Responsible party
- Principal investigator, Helle Søholm, MD, PhD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Helle Søholm, MD, PhD, Principal investigator, Dept. of Cardiology, RigshospitaletMartin Frydland, MD, PhD, Principal investigator, Dept. of Cardiology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350592
- Sponsor's protocol ID
- RH-CARD-Pharma001
- Other IDs
- 2021-002028-19, H-21045751, U1111-1277-8523
- Acronym
- DOBERMANN
- Status last verified
- Jul 2025
- First submitted
- 8 Mar 2022
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is planned to be available upon reasonable request via the Principal Investigator pending final, complete publication of the study.
Publications
Holle SLD, Kunkel JB, Hassager C, Pecini R, Wiberg S, Palm P, Holmvang L, Bang LE, Kjaergaard J, Thomsen JH, Engstrom T, Moller JE, Lonborg JT, Soholm H, Frydland M. Low-dose dobutamine in acute myocardial infarction with intermediate to high risk of cardiogenic shock development (the DOBERMANN-D trial): study protocol for a double-blinded, placebo-controlled, single-center, randomized clinical trial. Trials. 2024 Oct 30;25(1):731. doi: 10.1186/s13063-024-08567-y.
PubMed 39478521Kunkel JB, Holle SLD, Hassager C, Pecini R, Wiberg S, Palm P, Holmvang L, Bang LE, Kjaergaard J, Thomsen JH, Engstrom T, Moller JE, Lonborg JT, Frydland M, Soholm H. Interleukin-6 receptor antibodies (tocilizumab) in acute myocardial infarction with intermediate to high risk of cardiogenic shock development (DOBERMANN-T): study protocol for a double-blinded, placebo-controlled, single-center, randomized clinical trial. Trials. 2024 Nov 5;25(1):739. doi: 10.1186/s13063-024-08573-0.
PubMed 39501388
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Dobutamine Infusion and Single-dose Tocilizumab in Acute Myocardial Infarction Patients With High Risk of Cardiogenic Shock Development - a 2x2 Multifactorial, Double-blinded, Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT05350592
- Acronym / sponsor ID
- DOBERMANN / RH-CARD-Pharma001
- Conditions
- Acute Myocardial Infarction, Cardiogenic Shock
- Keywords
- acute myocardial infarction, cardiogenic shock, AMI, inflammation, proBNP, AMI-CS, infarct size, STEMI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Simon Spies Fonden, Helge Peetz og Verner Peetz og hustru Vilma Peetz Legat
- Study start
- 13 Mar 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 28 Apr 2022 (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 the present study, we aim to investigate the effects of dobutamine infusion and/or a single intravenous (IV) dose of the IL-6 antagonist Tocilizumab administered after percutaneous coronary intervention (PCI) to patients with acute myocardial infarction (AMI) presenting < 24 hours from onset of chest pain and an intermediate to high risk of cardiogenic shock (CS) by assessment with the ORBI risk score (≥10 - not in overt shock at hospital admission).
Plasma concentrations of pro-B-type natriuretic peptide (proBNP) as a proxy for development of cardiogenic shock (CS) and hemodynamic instability will be sampled for primary endpoint analysis.
Effects on clinical parameters, mortality, morbidity as well as specific indicators of inflammation, cardiac function, and infarct size will secondarily be assessed noninvasively.
The rationale behind the current study is that inflammatory and neurohormonal responses are associated with subclinical hemodynamic instability in patients with AMI with high risk of CS have worse outcomes. The potentially unstable condition may be targeted pharmacologically as an add-on to existing therapy. This is investigated in patients at elevated risk of CS by sampling biomarkers reflecting the inflammatory and neurohormonal responses, as well as determining effects on patient outcomes and infarct size.
Detailed description
The planned study is an investigator-initiated, randomized, double blinded clinical trial.
Consecutive patients at Copenhagen University Hospital, Rigshospitalet admitted with AMI < 24 hours from chest pain will be screened.
Patients eligible for trial inclusion will be randomized 2:2 to receive a continuous IV dobutamine infusion of 5 mcg/kg/minute versus placebo for 24 hours and to receive a single IV dose of tocilizumab (1-hour infusion) versus placebo administered after PCI.
Treatment with the investigational drug will be initiated as soon as possible but no later than 2 hours after transfer to the coronary care unit (CCU) and after informed consent. All included patients will follow usual treatment according to current guidelines.
The biomarker proBNP will be measured in blood samples drawn upon hospital admission in patients with ORBI risk score ≥10, and after 12, 24, 36 and 48 hours from admission.
After treatment termination, 2D-echocardiography will be performed acutely and within 2 days to evaluate left ventricular ejection fraction (LVEF), and cardiac magnetic resonance imaging (cMRi) with late gadolinium enhancement technique prior to hospital discharge as close to 48 hours post-MI and after 3 months after discharge will be performed to calculate area at risk and salvage index after AMI.Blood samples (40 mL) will be obtained and stored in a biobank for subsequent measurement of biomarkers reflecting inflammation, neurohormonal activation, neuronal injury, connective tissue function and other relevant pathophysiological processes.
These biomarkers will solely have research interest and no clinical implications. Furthermore, no genetic biomarkers and markers associated with malignancy development will be measured. Any leftover blood from the research biobank will be transferred to a biobank for future research and stored for up to 10 years solely for research purposes. After this period blood samples will be destroyed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab + Dobutamine | Active comparator | Drug: Tocilizumab, Drug: DobutamineTocilizumab IV 280 mg (100mL/hour, 1 hour) Dobutamine IV 5 micrograms/kg/minute (5mL/hour, 24 hours) |
| Tocilizumab + Placebo | Active comparator | Drug: Tocilizumab, Drug: NaCl 0.9%Tocilizumab IV 280 mg (100mL/hour, 1 hour) NaCl 0,9% IV (5mL/hour, 24 hours) |
| Placebo + Dobutamine | Active comparator | Drug: Dobutamine, Drug: NaCl 0.9%NaCl 0,9% IV (100mL/hour, 1 hour) Dobutamine IV 5 micrograms/kg/minute (5mL/hour, 24 hours) |
| Placebo + Placebo | Placebo comparator | Drug: NaCl 0.9%NaCl 0,9% IV (100mL/hour, 1 hour) NaCl 0,9% IV (5mL/hour, 24 hours) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute myocardial infarction
- Revascularization with PCI
- Presentation within 24 hours of chest pain
- ORBI risk score ≥ 10
- Age ≥ 18
Key exclusion criteria (13 listed)
- Unwilling to give informed consent to study participation
- Unable to give consent due to language barrier
- Comatose after cardiac arrest
- Cardiogenic shock with systolic blood pressure < 100 mmHg for more than 30 minutes or need for vasopressor to maintain blood pressure and arterial lactate > 2,5 (2,0) mmol/L developed before leaving the cath. lab.
- Other major clinical non-coronary condition (stroke, sepsis etc.), which can explain a high ORBI risk score
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 |
|---|---|---|
| TocilizumabAlso: RoActemra (Actemra)Single bolus | Drug | Tocilizumab + Dobutamine, Tocilizumab + Placebo |
| DobutamineAlso: DobutrexContinous weight-adjusted infusion | Drug | Placebo + Dobutamine, Tocilizumab + Dobutamine |
| NaCl 0.9%Also: Saline isotonicPlacebo comparator and diluent | Drug | Placebo + Dobutamine, Placebo + Placebo, Tocilizumab + Placebo |
Primary outcome
ProBNP
Time frame: 48 hours
ProBNP plasma concentration being assessed at multiple time points (including the primary endpoint) will be analyzed by application of a linear mixed model of covariance. As the biomarker will be measured prior to initiation of the study drug, the models will be baseline corrected (i.e., constrained linear mixed models, CLMM). The main result of these analyses will be the treatment-by-time interaction as a marker of whether the proBNP levels change differently over time in the treatment versus the placebo arm.
13 secondary outcomes
CS and/or cardiac arrest
Time frame: Index admission
Acute Infarct Size
Time frame: Admission
Post-infarction Salvaged Myocardium
Time frame: 3 months
Additional biomarkers
Time frame: Index admission
Post-procedure assessment
Time frame: Index admission
Development of non-cardiac arrest arrythmia
Time frame: Index admission
2D echocardiographic measurements of hemodynamics
Time frame: Admisson, 3 months
Re-admission
Time frame: One year
Heart Quality of Life (HeartQoL)
Time frame: Admission, 3 months
EuroQol Group EQ-5D Quality of Life (EQ-5D-5L)
Time frame: Admission, 3 months
HADS (Hospital Anxiety and Depression Scale)
Time frame: Admission, 3 months
The Montreal Cognitive Assessment (MOCA)
Time frame: Admission, 3 months
Clinical Frailty Scale (CFS)
Time frame: Admission, 3 months
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 17 Jul 2025.
- Background: PubMed 39478521Holle SLD, Kunkel JB, Hassager C, Pecini R, Wiberg S, Palm P, Holmvang L, Bang LE, Kjaergaard J, Thomsen JH, Engstrom T, Moller JE, Lonborg JT, Soholm H, Frydland M. Low-dose dobutamine in acute myocardial infarction with intermediate to high risk of cardiogenic shock development (the DOBERMANN-D trial): study protocol for a double-blinded, placebo-controlled, single-center, randomized clinical trial. Trials. 2024 Oct 30;25(1):731. doi: 10.1186/s13063-024-08567-y.
- Background: PubMed 39501388Kunkel JB, Holle SLD, Hassager C, Pecini R, Wiberg S, Palm P, Holmvang L, Bang LE, Kjaergaard J, Thomsen JH, Engstrom T, Moller JE, Lonborg JT, Frydland M, Soholm H. Interleukin-6 receptor antibodies (tocilizumab) in acute myocardial infarction with intermediate to high risk of cardiogenic shock development (DOBERMANN-T): study protocol for a double-blinded, placebo-controlled, single-center, randomized clinical trial. Trials. 2024 Nov 5;25(1):739. doi: 10.1186/s13063-024-08573-0.
- Individual participant dataSharing planned: Yes. Data is planned to be available upon reasonable request via the Principal Investigator pending final, complete publication of the study.
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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.
Helle Søholm, MD, PhD principal investigator
Dept. of Cardiology, Rigshospitalet
Martin Frydland, MD, PhD principal investigator
Dept. of Cardiology, Rigshospitalet
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 Tocilizumab, Dobutamine and NaCl 0.9% in people with Acute Myocardial Infarction and Cardiogenic Shock, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
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?
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?
ProBNP (time frame: 48 hours). 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 NCT05350592, which also lists 2 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 17 Jul 2025.