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

NCT ID: NCT04369573

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-04
• Study Completion Date: 2024-10-14

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

Conditions

Cardiogenic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early intra-aortic balloon pump (IABP) implantation

IABP implantation within 6 hours since cardiogenic shock symptoms onset

Group Type: ACTIVE_COMPARATOR

Early intra-aortic balloon pump (IABP) implantation

Intervention Type: COMBINATION_PRODUCT

IABP implantation within 6 hours since cardiogenic shock symptoms onset

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

Group Type: OTHER

Standard of care as vasoactive agent

Intervention Type: 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.

Interventions

Early intra-aortic balloon pump (IABP) implantation

IABP implantation within 6 hours since cardiogenic shock symptoms onset

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Niguarda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ASST GOM Niguarda

Milan, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 40162941 (View on PubMed)

Other Identifiers

S_21_08_19_3263

Identifier Type: -

Identifier Source: org_study_id