Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Early intra-aortic balloon pump (IABP) implantation
IABP implantation within 6 hours since cardiogenic shock symptoms onset
干预措施: Early intra-aortic balloon pump (IABP) implantation (Combination Product)
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
干预措施: Standard of care as vasoactive agent (Other)
结局指标
主要结局
Survival
时间窗: 60 days
Rate
Successful bridge to heart replacement therapies, namely heart transplantation or left ventricular assist device implantation
时间窗: 60 days
Number of participants to heart transplant or Left Ventricular Assist Device implantation
次要结局
- Maximum duration of inotropic/vasopressor therapy among the two groups(Through study completion, an avererage of 30 days)
- Maximum inotropic score 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)
- 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)