Pharmacokinetics of Inhaled Levosimendan
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Bioavailability of inhaled levosimendan
研究概览
简要总结
Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject >18 years of age
- •Scheduled for elective coronary artery bypass grafting (CABG)
- •Provided written informed consent
- •Impaired left ventricular function (LVEF <40%)
排除标准
- •Known allergy for levosimendan or solutes
- •Persistent angina, defined as Canadian Cardiovascular Society score > I
- •History of valvular intervention or uncorrected primary stenotic valve disease
- •Uncorrected thyroid disease
- •Infiltrative, hypertrophic or restrictive cardiomyopathy
- •Pericardial disease
- •Active myocarditis
- •Chronic obstructive pulmonary disease requiring long-term treatment with β-agonists, Theophylline, or corticosteroids (FEV1 < 80%; Tiffeneau-index <0.7)
- •History of serious arrhythmias, defined as a history of ventricular tachycardia or fibrillation other than that occurring within 24 hours after acute myocardial infarction (MI)
- •resting heart rate > 115 bpm for at least 10 minutes on repeated measurements
- •Supine systolic blood pressure < 85 mm Hg or >200 mm Hg
- •patients with implanted pacemaker/defibrillator or cardiac resynchronisation therapy (CRT-device)
- •primary renal or hepatic impairment (creatinine > 2.5 mg/dL or aspartate aminotransferase/alanine aminotransferase >2 times upper limit of normal and/or increased level of bilirubin (> 2 times the upper limit of normal and increase of international normalised ratio (INR) above the upper limit of normal, respectively)
- •Uncorrected hypokalemia or hyperkalemia (potassium <3.5 mmol/L or >5.5 mmol/L)
- •Uncorrected hypomagnesemia (magnesium <0.65mmol/L)
- •Treatment with another investigational agent within 30 days before study entry
- •Intubated and mechanically ventilated at the time of study entry
研究组 & 干预措施
Levosimendan inhalation
Levosimendan 12µg/kg inhalation over 10 minutes, once
干预措施: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled (Drug)
Levosimendan intravenous
Levosimendan 12µg/kg intravenous over 10 minutes, once
干预措施: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous (Drug)
结局指标
主要结局
Bioavailability of inhaled levosimendan
时间窗: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Assessment of bioavailability of inhaled levosimendan in spontaneous breathing patients,
Time-to-peak of inhaled levosimendan
时间窗: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Assessment of time-to-peak plasma concentration of inhaled levosimendan in spontaneous breathing patients
Elimination half-life of inhaled levosimenan
时间窗: Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation
Assessment of elimination half-life of inhaled levosimendan in spontaneous breathing patients
次要结局
- Effect of inhaled levosimendan on CO(Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation)
- Effect of inhaled levosimendan on LVOT VTI(Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation)
- Effect of inhaled levosimendan on SPAP(Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation)
- Effect of inhaled levosimendan on TVR(Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation)
- Effect of inhaled levosimendan on FAC of the right vetricle(Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation)
- Effect of inhaled levosimendan on MAP(Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation)
- Effect of inhaled levosimendan on S'(Baseline, plasma samples at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1hour 30 minutes, 2 hours , 3 hours , 6 hours, 10 hours after end of infusion/inhalation)