Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock
Reason given: Because the Data Safety Monitoring Board after the interim analisys concluded that the experimental treatment is not proviiding any minimal full benefit compared to the contrtol. They then reccomended to stop the trial due to futility
Key facts
- Where
- Milan, ItalySee the site
- Phase
- Phase 4
Where in Italy
- ASST GOM NiguardaMilan, ItalyNo longer taking part
Trial details
- Who runs it
- Niguarda Hospital
- Trial code
- NCT04369573
- Record updated
- 23 October 2024
- Original 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).Read full original descriptionShow less
Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock: a Randomized Clinical Trial
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).
Inclusion: 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: severe peripheral vascular disease; CS secondary to cardiac and non-cardiac surgery; Acute myocardial infarction within 1 month; Chronic end-stage organ dysfunction that would preclude heart transplant/durable VAD; 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; septic shock with evident septic focus; Suspected or documented myocarditis; Pulmonary embolism; ominous prognosis (life expectancy < 1 year); pregnant, lactating or women planning pregnancy during the course of the trial.