EUCTR2013-002847-28-DE进行中（未招募）1 期
Multicenter, open-label, dose escalation study to evaluate safety, tolerability and pharmacokinetics of RLX030 in addition to standard of care in pediatric patients from birth to <18 years of age, hospitalized with acute heart failure.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent by parent(s)/legal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed
- •2. Male or female, birth to <18 years of age, with body weight =2.5 kg to =120 kg
- •3. Hospitalized in an intensive/critical care unit or continuously monitored step-down unit with the following:
- •a) signs and symptoms of AHF of any etiology
- •b) a stable dose of vasoactive and/or inotropic agents
- •c) for non-surgical patients (medical etiologies of AHF), echocardiographic evidence of reduced ventricular function is required as follows:
- •i.Ejection fraction of the systemic or pulmonary ventricle <50% in patients with systemic left ventricular dysfunction, or
- •ii.Fractional shortening <28% in patients with systemic left ventricular dysfunction, or
- •iii.Qualitative evidence of a dilated ventricle with at least mild systemic ventricular systolic dysfunction in patients with right ventricular or single ventricular physiology
- •4. Systolic blood pressure (SBP) consistently equal to or greater than the calculated 25th percentile SBP for age and gender per the protocol.
- •5. Stable pulmonary function, i.e. patient is extubated or is stable on ventilator support.
- •Additional details are listed in the clinical study protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Hypovolemia
- •2. Moderate to severe left ventricular outflow tract (including sub-valvular, valvular and supra-valvular), mitral stenosis or aortic arch obstruction
- •3. Patients with single ventricle physiology before their Fontan operation
- •(However, single ventricle patients post Glenn operation before their Fontan/Total cavopulmonary connection procedure (TCPC) can be enrolled.)
- •4. Patients on ECMO or VAD
- •5. Patients with fixed pulmonary hypertension
- •6. Patients with blood lactate levels >5 mmol/L at screening
- •7. Birth < 36 weeks post-conceptual age (applies only to children <1year old at baseline)
- •8. Confirmed or clinically suspected systemic infection (sepsis) or severe localized infection requiring iv antibiotics
- •9. Dyspnea or acute lung injury primarily due to non-cardiac causes
- •10. Patients with severe renal impairment, those known to have significant renal disease and those having current or planned renal replacement therapy
- •11. Excessive use of inotropic and/or vasoactive agents at screening (vasoactive score >20)
- •12. Current or planned use of the following concomitant medications during the duration of the study drug infusion: levosimendan, nesiritide
- •13. History or current diagnosis of cardiac electrocardiographic abnormalities
- •14. Any major solid organ transplant recipient within 1 year of transplantation
- •15. Any major solid organ transplant recipient who presents with severe organ rejection
研究者
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