EUCTR2004-004225-10-FI进行中（未招募）不适用
Effects of peroral levosimendan in the prevention of further hospitalisations in patients with chronic heart failure. A randomised, double-blind, placebo-controlled, multi-centre, parallel-group study - PERSIST
适应症
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
- 300
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 obtained
- •2. Male and female patients over 18 years of age. Women of reproductive age and potential must refrain from breastfeeding, must have a negative pregnancy test and must commit to using an acceptable method of barrier or hormonal contraception (e.g. condoms, diaphragms, oral contraceptives and long acting progestin agents) if sexually active during the study and for 1 month after the last dose of the study
- •treatment. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be of childbearing potential
- •3. Chronic heart failure diagnosed at least 3 months before screening
- •4. Treatment for at least 1 month before screening with angiotensin converting enzyme (ACE) inhibitor or beta-blocker and additionally at least one of the following: diuretics, digitalis, aldosterone antagonist or angiotensin II receptor blocker
- •5. Left ventricular ejection fraction less than or equal to 30% as assessed by echocardiography, radionuclide ventriculography or contrast angiography within 12 months before screening
- •6. NYHA IIIb-IV symptoms (dyspnoea on minimal exertion or at rest) at screening and at baseline
- •7. Further evidence of severely compromised heart failure as evidenced by one of the following at screening:
- •- History of at least one hospitalisation or visit to out-patient clinic for worsening heart failure requiring treatment either with intravenous (i.v.) diuretics, i.v. vasodilators, and/or i.v. inotropic agents within 6 months before screening; the index hospitalisation may be currently on-going at screening but if so, the patient must be ready to be discharged
- •- Plasma N-terminal-pro-B-type natriuretic peptide (NT-pro-BNP) above or equal to 1000 pg/ml at screening
- •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. Cardiac surgery or coronary angioplasty within 30 days before screening
- •3. Acute myocardial infarction within 30 days before screening
- •4. Patients who are scheduled to receive a heart transplant or left ventricular assist device or are scheduled for coronary by-pass or angioplasty in the next 6 months
- •5. History of life-threatening ventricular arrhythmia within 3 months defined as an episode of resuscitated sudden death, ventricular fibrillation or sustained or haemodynamically destabilising ventricular tachycardia (wide complex tachycardia >100/min, either for >15 seconds or accompanied by hypotension,
- •presyncope or syncope). Patients with one of these three arrhythmias may be enrolled if the episode was followed by placement of an intracardiac cardioverter-defibrillator (ICD) (and the ICD has not fired within 30 days)
- •6. History of Torsades de Pointes or family history of long QT-syndrome
- •7. Stroke or transient ischaemic attack within 3 months before screening
- •8. Systolic blood pressure less than 85 mmHg at screening and baseline
- •9. Heart rate 100 bpm or greater at screening and baseline
- •10. Serum potassium less than 3.5 mmol/l at screening
- •11. Severe renal insufficiency (serum creatinine >450 µmol/l [5.0 mg/dl]) or on dialysis
- •12. Severe anaemia (blood haemoglobin <10 g/dl) at screening
- •13. Significant hepatic impairment at discretion of the investigator
- •14. Hypersensitivity to levosimendan
- •15. Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer)
- •16. Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
- •17. Administration of levosimendan within 30 days prior to screening
研究者
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