Clinical trial NCT04369573: Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock
Official title: Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cardiogenic Shock
Keywords: Acute decompensated heart failure
cardiogenic shock
intra-aortic balloon pump
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Successful bridge to heart replacement therapies, namely heart transplantation or left ventricular assist device implantation
timeFrame: 60 days
measure: Survival
timeFrame: 60 days
Secondary outcomes:
measure: 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
timeFrame: 60 days
measure: Maximum inotropic score among the two groups
timeFrame: Through study completion, an avererage of 30 days
measure: Maximum duration of inotropic/vasopressor therapy among the two groups
timeFrame: Through study completion, an avererage of 30 days
measure: Maximum sequential organ failure assessment (SOFA)
timeFrame: Through study completion, an avererage of 30 days
measure: early IABP vs standard
timeFrame: 60 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST GOM Niguarda
Study officials:
References: