Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock (Altshock-2)

Niguarda Hospital

Status and phase: Terminated; Phase 4

Conditions: Cardiogenic Shock

Treatments: Combination Product: Early intra-aortic balloon pump (IABP) implantation; Other: Standard of care as vasoactive agent

Study type: Interventional

Funder types: Other

Identifiers

NCT04369573

S_21_08_19_3263

Details and patient eligibility

About

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).

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Early intra-aortic balloon pump (IABP) implantation

Active Comparator group

Description:

IABP implantation within 6 hours since cardiogenic shock symptoms onset

Treatment:

Combination Product: Early intra-aortic balloon pump (IABP) implantation

Standard of care as vasoactive agent

Other group

Description:

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

Treatment:

Other: Standard of care as vasoactive agent