EUCTR2008-001254-41-SE进行中（未招募）不适用
A single-centre, single-blind, randomised, placebo-controlled phase IIa study to investigate the effect of AZD1305 given as an iv infusion on left ventricular performance in patients with left ventricular dysfunction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.Provision of informed consent
- •2.Male patients and postmenopausal women aged 20-80 years
- •3.LVEF 30- 45% on echocardiography.Patients with an ejection fraction >45% can be included if he/she has a well documented diagnosis of cardiac failure/cardiomyopathy with a previous EF below 45% and is judged to have normal ejection fraction due to optimised medical treatment.
- •4.In SR without diagnosis of AF during the dosing days.
- •5.No significant changes in the medication for heart failure, during the preceding 1 month before enrolment (e.g. ACE inhibitors, AT1 blockers, beta-receptor blockers and/or aldosterone antagonists, diuretics) as judged by the investigator
- •6. deleted
- •7.Provision of written informed consent for genetic research (optional).
- •1. Women will be considered postmenopausal if they fulfil criterion a) and/or b), and criterion c):
- •a) Natural menopause with last menstruation >1 year ago
- •b) Induced menopause with last menstruation >1 year ago, due to:
- •-Bilateral oophorectomy and/or hysterectomy
- •-Radiation induced oophorectomy
- •-Chemotherapy induced menopause
- •c) Serum FSH, LH and/or plasma oestradiol levels in the postmenopausal range as defined by the laboratory.
- •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.Clinically significant deviation in physical findings or laboratory values as judged by the investigator
- •2.Severe or clinically unstable heart failure (NYHA III-IV)
- •3.Haemodynamically unstable condition as judged by the investigator, systolic blood pressure (BP) <100 mmHg or >180 mmHg, or diastolic BP >105 mmHg at enrolment
- •4.AV-block I (prolonged PQ (PR) interval defined as >220 ms), AV-block II, AV-block III, bundle branch block (BBB)
- •5.QRS duration >120 ms at randomization
- •6.QTcF interval >450 ms measured at randomization
- •7.Any of the following events, or any other significant cardiovascular event as judged by the investigator, during the last 3 months before randomisation: myocardial infarction, unstable angina pectoris or other signs of myocardial ischaemia, stroke or transient ischaemic attack (TIA), myocardial revascularisation (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG))
- •8.Significant clinical illness or surgical procedure within 4 weeks preceding the pre-entry visit
- •9.Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome and/or Brugada syndrome
- •10.History of past or ongoing severe allergic disease, significant mental, renal or hepatic disorder, or other significant disease as judged by the investigator
- •11.Known preexcitation
- •12.History and/or signs of clinically significant sinus node dysfunction, or sinus rhythm with a heart rate (HR) below 45 or above 100 beats per minute
- •13.Pacemaker or Implantable Cardioverter Defibrillator (ICD) therapy
- •14.Significant aortic stenosis or hypertrophic obstructive cardiomyopathy
- •15.C-Reactive Protein (CRP) >15 mg/L
- •16.Potassium in serum or plasma below 3.8 or above 5.3 mmol/L
- •17.Blood Haemoglobin (Hb) <100 g/L at randomisation
- •18.Glomerular filtration rate (GFR) calculated according to the Cockcroft-Gault formula1 <30 mL/min
- •1.Estimated glomerular filtration rate (GFR) for men and women as follows:
- •1.Estimated glomerular filtration rate (GFR) for men and women as follows:
- •Creatinine Clearance men=1.23 x (140 - age (years) x weight (kg)/serum creatinine (µmol/l)
- •Creatinine Clearance women=1.04 x (140 - age (years) x weight (kg)/(serum creatinine (µmol/l)
- •19.Intake of over-the-counter”-drugs, including herbals, such as St John’s worth (within 3 weeks), vitamins, minerals and also grapefruit (including grapefruit juice) within one week before the first administration of AZD1305
- •20.Use of any antiarrhythmic drug (e.g. class I and/or III, sotalol, digitalis glycoside, verapamil and amiodarone)
- •21.Use of QT prolonging drug and/or drug that inhibits CYP3A4, as well as St John’s Worth within five half-lives before administration of AZD1305
- •22.History of drug addiction and/or alcohol abuse and/or positive drug screen
- •23.Clinical judgement by the investigator that the patient should not participate in the study
- •24.A suspect or manifest infection according to IATA risk categories A and B
- •25.Regular use of nicotine (smoking, snuff, nicotine chewing gum or nicotine plaster) daily (average of >7 cigarettes or snuff portions per week)
- •26.Blood or plasma donation within the preceding 12 weeks before the administration of AZD1305 or other investigational product
- •27.Intake of an investigational drug within the preceding 3 months before the first administration of AZD1305
- •28.Intake of AZD7009 (predecessor of AZD1305) and/or AZD130
研究者
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