Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock (Altshock-2)
Cardiogenic Shock
About this trial
This is an interventional treatment trial for Cardiogenic Shock focused on measuring Acute decompensated heart failure, cardiogenic shock, intra-aortic balloon pump
Eligibility Criteria
INCLUSION CRITERIA
- Age ≥ 18 and < 75, men and women;
- need of vasoactive agents to maintain SBP > 90 mmHg or MAP > 60 mmHg.
- Left ventricle systolic function ≤35%
- SCAI B-D according to CSWG definition (JACC 2022)
EXCLUSION CRITERIA
- septic shock with evident septic focus;
- severe peripheral vascular disease
- CS secondary to cardiac and non-cardiac surgery;
- Acute myocardial infarction within 1 month;
- Suspected or documented myocarditis
- Pulmonary embolism
- Chronic end-stage organ dysfunction that would preclude heart transplant/durable VAD
- ominous prognosis (life expectancy < 1 year);
- any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
- pregnant, lactating or women planning pregnancy during the course of the trial.
Sites / Locations
- ASST GOM NiguardaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Early intra-aortic balloon pump (IABP) implantation
Standard of care as vasoactive agent
IABP implantation within 6 hours since cardiogenic shock symptoms onset
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