Use of mechaNical Left ventricuLar unlOading in Acute decompensateD Heart Failure Complicated by Cardiogenic Shock - the UNLOAD HF-CS Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 456
- 试验地点
- 5
- 主要终点
- Composite of all-cause mortality, renal replacement therapy and rehospitalization or urgent visit for heart failure (Efficacy - Primary Combined Clinical Endpoint)
研究概览
简要总结
The purpose of this research study is to evaluate whether timely and aggressive temporary Mechanical Circulatory Support (tMCS) through the Impella 5.5® in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) has the potential to reduce the HF-CS related clinical events compared to the current standard of care.
详细描述
To demonstrate the efficacy of timely temporary mechanical left ventricular unloading with the Impella 5.5® assist device in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) vs. current standard of (pharmacological) care
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
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
- •Evidence of HFrEF according to ESC HF guidelines (LVEF ≤ 35%)
- •Signs of (persistent) congestion (elevated CVP, edema, rales, ascites, pleural effusion)
- •Evidence of CS with presence of at least 2 of the 3 following:
- •Hypotension
- •systolic blood pressure <90 mmHg for at least 30 min OR
- •mean arterial pressure <60 mmHg for at least 30 min
- •Hypoperfusion
- •lactate > 2.0 mmol/L (two consecutive values > 2 mmol/L with at least 30 min between samples, with non-decreasing trend on if on (steady doses of) inotropes and/or vasopressors)
- •amino-L-transferase >200 U/L (two consecutive values > 200 Ul/L with at least 30 min between samples, with non-decreasing trend if on (steady doses of) inotropes and/or vasopressors)
- •creatinine rise ≥ 0.3 mg/dl/24h ( 26,53 μmol/L)
- •oliguria (≤ 0,5 ml/kg/h, ≤ 720 ml/24 h)
- •Inotropes/vasoactives (use of)
排除标准
- •Contraindications for Impella 5.5
- •Severe concomitant RV failure
- •Grade IV mitral regurgitation eligible for surgical treatment
- •Dialysis for end-stage renal failure
- •Acute coronary syndrome (type 1, AMI)
- •Bradycardia and AV blocks necessitating pacemaker implantation
- •HD parameters and biochemistry alterations as specifically defined for SCAI CS E
- •Combined cardiorespiratory failure
- •Resuscitated (OHCA/PEA)
- •History of CVA or TIA within previous 90 days
- •History of acute myocardial infarction within previous 30 days
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions
- •Inflammatory
- •Active systemic infections
- •Acute myocarditis
研究组 & 干预措施
Impella 5.5
ADHF-CS patients who are in the experimental arm will be treated with an Impella 5.5 (+/- standard of care)
干预措施: Impella 5.5 (Device)
Standard of care
ADHF-CS patients who are in the control arm will be treated with escalating doses of inotropes (standard of care)
干预措施: Inotropes (Drug)
结局指标
主要结局
Composite of all-cause mortality, renal replacement therapy and rehospitalization or urgent visit for heart failure (Efficacy - Primary Combined Clinical Endpoint)
时间窗: baseline to 90 days
Number of patients suffering from any of: all-cause death, renal replacement therapy and rehospitalization or urgent hospital visit for heart failure up to 90 days
次要结局
- Hospitalization or urgent hospital visit for heart failure (Efficacy - Secondary Endpoint)(baseline to 1 year)
- In-hospital mortality (Efficacy - Secondary Endpoint)(baseline to 28 days)
- In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint)(baseline to 28 days)
- Vasoactive Inotropic Score (maximal) (Efficacy - Secondary Endpoint)(baseline to 28 days)
- KCCQ-12 (Efficacy - Secondary Endpoint)(90 days, 1 year)
- Major vascular events (Safety - Secondary Endpoint)(baseline to 28 days)
- Aortic valve injury (Safety - Secondary Endpoint)(baseline to 90 days)
- All-cause mortality (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Mechanical ventillation (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Cardiac mortality (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Renal replacement therapy (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Urgent / rescue MCS implantation (permanent) (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Hospitalization time (Efficacy - Secondary Endpoint)(baseline to 28 days)
- LVAD / Heart transplantation (Efficacy - Secondary Endpoint)(baseline to 1 year)
- Stroke or TIA (Safety - Secondary Endpoint)(baseline to 28 days)
- Major Bleeding (Safety - Secondary Endpoint)(baseline to 28 days)
- Extremity ischemia (Safety - Secondary Endpoint)(baseline to 28 days)
- Hemolysis (Safety - Secondary Endpoint)(baseline to 28 days)
- Insertion site infection (Safety - Secondary Endpoint)(baseline to 28 days)
研究者
Alexander Nap
Principal Investigator
Amsterdam UMC, location VUmc