NCT02973620No Longer Available不适用
Expanded Access Protocol; Intermediate Size Protocol: Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure Who Are Refractory to Standard Therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
Open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≤18 years of age with acute or acute on chronic decompensated heart failure.
- •Male or female, ≤18 years of age on ECMO support and unable to wean from ECMO support.
- •Informed Consent signed by the subject's parents or their legally acceptable representatives indicating that they understand the purpose of and procedures required for expanded access and are willing to participate in the study.
- •Patients meeting one of the following definitions of failed standard therapy of decompensated heart failure
排除标准
- •Patients < 36 weeks gestational age
- •Patients weighing < 2 kg
- •Obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade
- •Estimated glomerular filtration rate (eGRF) < 30 mL/min/1.73m
- •Known allergic reaction or sensitivity to levosimendan or excipients.
- •A history of Torsades de Pointes, uncorrectable hypo- or hyperkalemia, uncorrectable hypo- or hypercalcemia
- •Pregnant, suspected to be pregnant, or breast-feeding.
- •Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
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