NCT00348504已完成3 期
Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 1,300
- 试验地点
- 2
- 主要终点
- All-cause mortality in the 180 days following randomization.
研究概览
简要总结
The primary objective of the study is to compare the efficacy of levosimendan and dobutamine on all-cause mortality in the 180 days following randomization.
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
- Double
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
- •Written, signed and dated informed consent
- •Male and female patients over 18 years of age. Females of childbearing potential must have a negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal [two years since last menstrual cycle], surgically sterilised or who have undergone a hysterectomy are considered not to be of childbearing potential
- •Hospitalised patients with acutely decompensated heart failure
- •Left ventricular ejection fraction less than or equal to 30 % as assessed using echocardiography, radionuclide ventriculography or contrast angiography within 12 months
- •Clinical need for intravenous inotropic support as evidenced by insufficient response to intravenous diuretics and/or vasodilators (nitroglycerin, nitroprusside) and at least one of the following at screening:
- •oliguria (mean urine output < 30 ml/h for at least 6 hours) and not a result of hypovolemia
- •dyspnoea at rest or mechanical ventilation for heart failure
- •haemodynamic impairment in those patients with Swan-Ganz catheter inserted (PCWP ≥ 18 mmHg and/or Cardiac Index ≤ 2.2 l/min/m2)
排除标准
- •Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy
- •Weight ≥ 160 kg
- •Cardiac surgery within 30 days before screening
- •Stroke within 3 months before screening
- •Systolic blood pressure persistently less than 85 mmHg at screening or at baseline
- •Heart rate persistently 130 bpm or greater at screening or at baseline
- •Serum potassium less than 3.5 mmol/l at screening
- •Administration of any inotropic agent (e.g. dobutamine, milrinone, amrinone, enoximone, epinephrine, norepinephrine) except digitalis or dopamine (with dose of less than or equal than 2 mg/kg/min) during the current hospitalisation
- •Hypersensitivity to levosimendan or dobutamine or any of their excipients
- •A history of Torsades de Pointes
- •Severe renal insufficiency (serum creatinine > 450 mmol/l [5.0 mg/dl]) or on dialysis
- •Significant hepatic impairment at discretion of the investigator
- •Acute bleeding
- •Severe anemia (haemoglobin < 8 g/dl) at screening
- •Septicaemia or septic shock
- •Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer)
- •Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
- •Administration of levosimendan within 30 days prior to screening
结局指标
主要结局
All-cause mortality in the 180 days following randomization.
次要结局
- All-cause mortality during the 31 days following randomization
- Mean change in plasma BNP concentration from baseline to 24 hours after the start of the study drug infusion
- Number of day alive and out of hospital (DAOH) during the 180 days following randomization
- Patient's evaluation of change in dyspnea at 24 hours following randomization
- Patient's evaluation of change in Global Assessment at 24 hours following randomization
- Cardiovascular mortality during the 180 days following randomization
研究者
研究点 (2)
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