Status:
TERMINATED
Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock
Lead Sponsor:
Niguarda Hospital
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 fai...
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 hemodynami...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04369573
Start Date
May 4 2020
End Date
October 14 2024
Last Update
October 23 2024
Active Locations (1)
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1
ASST GOM Niguarda
Milan, Italy, 20125