Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock
- Conditions
- Cardiogenic Shock
- Interventions
- Combination Product: Early intra-aortic balloon pump (IABP) implantationOther: Standard of care as vasoactive agent
- Registration Number
- NCT04369573
- Lead Sponsor
- Niguarda Hospital
- Brief Summary
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).
- Detailed Description
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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early intra-aortic balloon pump (IABP) implantation Early intra-aortic balloon pump (IABP) implantation IABP implantation within 6 hours since cardiogenic shock symptoms onset Standard of care as vasoactive agent Standard of care as vasoactive agent 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
- Primary Outcome Measures
Name Time Method Survival 60 days Rate
Successful bridge to heart replacement therapies, namely heart transplantation or left ventricular assist device implantation 60 days Number of participants to heart transplant or Left Ventricular Assist Device implantation
- Secondary Outcome Measures
Name Time Method Maximum duration of inotropic/vasopressor therapy among the two groups Through study completion, an avererage of 30 days To compare maximum duration of inotropic/vasopressor therapy among the two groups (early IABP vs standard)
Maximum inotropic score among the two groups Through study completion, an avererage of 30 days 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)Maximum sequential organ failure assessment (SOFA) Through study completion, an avererage of 30 days To compare maximum sequential organ failure assessment (SOFA)
early IABP vs standard 60 days To compare 60-day overall survival among the two groups
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 60 days Number of participants who need a renal replacement therapy among the two groups (early IABP vs standard)
Trial Locations
- Locations (1)
ASST GOM Niguarda
🇮🇹Milano, Italy