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

NCT04369573 | Terminated Phase 4

• 1 other identifier: S_21_08_19_3263
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiogenic Shock

Keywords

Acute decompensated heart failure; cardiogenic shock; intra-aortic balloon pump

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

• Maximum inotropic score among the two groups

  Through study completion, an avererage of 30 days

• Maximum duration of inotropic/vasopressor therapy among the two groups

  Through study completion, an avererage of 30 days

• Maximum sequential organ failure assessment (SOFA)

  Through study completion, an avererage of 30 days

• early IABP vs standard

  60 days

Study Arms (2)

Early intra-aortic balloon pump (IABP) implantation

ACTIVE COMPARATOR

IABP implantation within 6 hours since cardiogenic shock symptoms onset

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

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

Other: Standard of care as vasoactive agent

Interventions

Early intra-aortic balloon pump (IABP) implantation COMBINATION_PRODUCT

IABP implantation within 6 hours since cardiogenic shock symptoms onset

Early intra-aortic balloon pump (IABP) implantation

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.

Standard of care as vasoactive agent

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST GOM Niguarda

Milan, 20125, Italy

Location

Related Publications (1)

• 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.

  PMID: 40162941 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Drug Implants; Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 30, 2020
• Study Start: May 4, 2020
• Primary Completion: October 14, 2024
• Study Completion: October 14, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

IT (1)