Clinical trial
Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock: a Randomized Clinical Trial
Name
S_21_08_19_3263
Description
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).
Trial arms
Trial start
2020-05-04
Estimated PCD
2025-03-30
Trial end
2025-04-01
Status
Recruiting
Phase
Early phase I
Treatment
Early intra-aortic balloon pump (IABP) implantation
IABP implantation within 6 hours since cardiogenic shock symptoms onset
Arms:
Early intra-aortic balloon pump (IABP) implantation
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.
Arms:
Standard of care as vasoactive agent
Size
200
Primary endpoint
Successful bridge to heart replacement therapies, namely heart transplantation or left ventricular assist device implantation
60 days
Survival
60 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-11-09
1 organization
1 product
1 indication
Organization
Niguarda HospitalIndication
Cardiogenic Shock