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Because the Data Safety Monitoring Board after the interim analisys concluded that the experimental treatment is not proviiding any minimal full benefit compared to the contrtol. They then reccomended to stop the trial due to futility
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The aim of the study is to demonstrate the superiority of early intra-aortic balloon pump implantation at admission over local clinical practice (pharmacological only) in acute decompensated heart failure patients with cardiogenic shock, with respect to 60-day survival or successful bridge to heart replacement therapies (heart transplant or Left Ventricular Assist Device implantation).
Cardiogenic shock (CS) is the most severe form of acute heart failure, with in-hospital mortality up to 50%. Failure to improve mortality has been reported, despite observed improvements in hemodynamics. Previous studies on CS have almost exclusively been focused on CS following an acute coronary syndrome (ACS). Chronic heart failure patients with acute decompensation (ADHF) and CS represent a unique physiologic phenotype compared with ACS patients, which may lead to a differential response to device therapy. Recent evidences emphasize that intra-aortic balloon pump (IABP) is not recommended for patients with ACS-related CS, but it is associated with a high likelihood of bridge to durable Left Ventricular Assist Device or heart transplant without the need for escalation to more potent temporary mechanical circulatory support devices, when implanted in ADHF patients. Data retrieved from the available literature in the setting of patients with CS not related to ACS are poor even in large, well-reported registries.
Accordingly, Altshock-2 trial has been designed to test the superiority of early IABP implantation at admission over local clinical practice (pharmacological only) in ADHF patients with CS, with respect to 60-day survival or successful bridge to heart replacement therapies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early intra-aortic balloon pump (IABP) implantation | Active Comparator | IABP implantation within 6 hours since cardiogenic shock symptoms onset |
|
| Standard of care as vasoactive agent | Other | Any agent (inotropes and vasopressors) will be allowed. However, the following guide is provided to increase uniformity: 1) vasopressors allowed will be either epinephrine or norepinephrine; 2) as inotropic agent milrinone or dobutamine or levosimendan could be used; 3) dopamine will be allowed in association with milrinone or dobutamine or levosimendan; 4) the maximum inotropic score allowed will be 20 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early intra-aortic balloon pump (IABP) implantation | Combination Product | IABP implantation within 6 hours since cardiogenic shock symptoms onset |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful bridge to heart replacement therapies, namely heart transplantation or left ventricular assist device implantation | Number of participants to heart transplant or Left Ventricular Assist Device implantation | 60 days |
| Survival | Rate | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Renal replacement therapy, namely any need of replacement of kidney function due to renal failure by means of the following techniques: continuous hemofiltration and hemodialysis, intermittent hemodialysis, and peritoneal dialysis | Number of participants who need a renal replacement therapy among the two groups (early IABP vs standard) | 60 days |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST GOM Niguarda | Milan | 20125 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40162941 | Derived | Morici N, Sacco A, Frea S, Rota M, Villanova L, Gravinese C, Dini CS, D'Ettore N, Maj G, De Lio G, Potena L, Valente S, Sabatino M, Viola G, Garatti L, Tavecchia GA, Bertoldi L, Oliva F, Kapur NK, Tavazzi G, De Ferrari GM, Pappalardo F; Altshock-2 Investigators. Early Intra-Aortic Balloon Support for Heart Failure-Related Cardiogenic Shock: A Randomized Clinical Trial. J Am Coll Cardiol. 2025 Apr 29;85(16):1587-1597. doi: 10.1016/j.jacc.2025.03.003. Epub 2025 Mar 30. |
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Multicentre Prospective Controlled Randomized Trial in patients with ADHF complicated by CS. Patients will be randomized 1:1 to early IABP versus standard of care. Early IABP will be defined as IABP implantation for CS patients within 6 hours since CS symptoms onset.
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Open
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| Standard of care as vasoactive agent | Other | Any agent (inotropes and vasopressors) will be allowed. However, the following guide is provided to increase uniformity: 1) vasopressors allowed will be either epinephrine or norepinephrine; 2) as inotropic agent milrinone or dobutamine or levosimendan could be used; 3) dopamine will be allowed in association with milrinone or dobutamine or levosimendan; 4) the maximum inotropic score allowed will be 20. |
|
| Maximum inotropic score among the two groups | To compare maximum inotropic score among the two groups (early IABP vs standard). IS (mcg/kg/min) = [dopamine, dobutamine + 100 x (norepinephrine+epinephrine) +15 x IPDE-3 +10for levosimendan] (Reference: Int J Artif Organs. 2016 Feb;39(2):94-7) | Through study completion, an avererage of 30 days |
| Maximum duration of inotropic/vasopressor therapy among the two groups | To compare maximum duration of inotropic/vasopressor therapy among the two groups (early IABP vs standard) | Through study completion, an avererage of 30 days |
| Maximum sequential organ failure assessment (SOFA) | To compare maximum sequential organ failure assessment (SOFA) | Through study completion, an avererage of 30 days |
| early IABP vs standard | To compare 60-day overall survival among the two groups | 60 days |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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