EUCTR2004-001225-16-AT进行中（未招募）不适用
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. - The SURVIVE study
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Orion Pharma
- 入组人数
- 700
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, signed, and dated informed consent.
- •2. Male and female patients over 18 years of age. Females of child bearing 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 have undergone a hysterectomy are considerd not to be of child bearing potential.
- •3. Hospitalised patients with acutely decompensated heart falure.
- •4. Left ventricular ejection fraction less than or equal to 30% as assessed using echocardiography, radionuclide ventriculography or contrast angiography within 12 months.
- •5. 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:
- •oligouria (mean urine output <30 ml/h for at least 6 hours) and not a results of hypovolemia.
- •dyspnoea at rest or mechanical ventilation for heart failure
- •haemodynamic impairment in those patients with Swan-Ganz catheter inserted (PCWP > or= 18 mm Hg and/or Cardiac Index < or = 2.2 l/min/m2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. 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.
- •2. Weight > or = 160kg.
- •3. Cardiac surgery within 30 days before screening.
- •4. Stroke within 3 months before screening.
- •5. Systolic blood pressure persistently less than 85 mmHg at screening or baseline.
- •6. Heart rate persistently 130 bpm or greater at screening or baseline.
- •7. Serum potassium less than 3.5 mmol/l at screeing.
- •8. Administration of any inotropic agent (e.g. dobutamine, milrinone, amrinone enoximone, epinephrine, norepinephrine) except digitalis or dopamine (with doses less than or equal than 2 microg/kg/min) during the current hospitalisation.
- •9. Hypersensitivity to levosimendan or dobutamine or any of their excipients.
- •10.A history of Torsades de Pointes.
- •11. Severe renal insufficiency (serum creatine > 450 micromol/l [5.0 mg/dl]) or on dialysis.
- •12. Significant hepatic impairment at discretion of the investigator.
- •13. Acute bleeding.
- •14. Severe anemia (haemoglobin < 8 g/dl) at screening.
- •15. Septicaemia or septic shock.
- •16. Other serious diseases limiting life expectancy considerably (e.g. end stage cancer).
- •17. Participation in a clinical trial with any experimental treatment within 30 days prior to sreening or previous participation in the present study.
- •18. Administration of levosimendan within 30 days prior to screening.
研究者
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