NCT01214096终止3 期
A Multi-center, Randomized, Double-blind , Placebo Parallel Controlled, Standard Therapy Based Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
Zensun Sci. & Tech. Co., Ltd.4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- cardiac function measured by MRI
研究概览
简要总结
Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
详细描述
- Subcutaneous Administration of NRG-1 is well tolerated by CHF patients
- Subcutaneous Administration of NRG-1 improves the cardiac function of CHF patients
- Assessment of relative bioavailability of NRG-1 by Subcutaneous Administration
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old, no limitation in gender;
- •Left ventricular ejection fraction (LVEF) ≤ 40% (ECHO);
- •Patients with chronic heart failure (NYHA class II or III);
- •In the past one month, the clinical condition (including history, clinical symptoms and signs) was relatively stable;
- •Patients on standard treatment of chronic heart failure at the target dose or maximum tolerance dose for over 1 month ,or unchanged dose in last 1 month;
- •Understand and sign the informed consent form;
排除标准
- •Atrial fibrillation;
- •Subject underwent cardiac pacemaker treatment;
- •Subject underwent metal graft treatment;
- •Claustrophobia;
- •Acute myocardial infarction, cardiac ischemia indicated by 6-minute walk test, hypertrophic cardiomyopathy, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension;
- •Ischemic heart failure without the revascularization or undergone the revascularization within last 6 months;
- •Subject underwent cardiac surgery or cerebrovascular events within the previous six months;
- •Subjects who plan to have cardiac transplantation;
- •Severe hepatic and renal insufficiency (serum creatinine>2.0 mg /dl, AST or ALT is five times higher than the upper limit of normal range);
- •Subject needs mechanical ventilation;
- •Systolic blood pressure < 90mmHg, or > 160mmHg;
- •Chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation within last 1 month;
- •Mobitz Type II or III° atrial ventricular block，severe ventricular arrhythmia (polymorphic and frequent premature ventricular beats, frequent non-sustained ventricular tachycardia);
- •Serum potassium<3.2mmol/L, or>5.5mmol/L;
- •Female subject is pregnant or plan to become pregnant
- •Childbearing-aged female subject who is unmarried or dose not bear child;
- •Subject with life expectancy less than 6 months as assessed by investigators;
- •Subject participated in any other clinical trial within the previous three months;
- •Subject with previous history of tumor, or current tumor patient, or subject with pre-cancerous disease manifested by pathological examination (such as ductal carcinoma in situ or cervical epithelial dysplasia)
- •Examinations (physical examination, X-ray examination, type-B ultrasonic detection or other methods) reveal that the subject has malignant mass, gland hyperplasia or adenoma with endocrine activity, or impact on heart, or endocrine function (such as pheochromocytoma, thyroid enlargement);
- •The Investigator deemed for whatever reason that the subject is not likely to complete the study or comply with the study procedures (due to administration or any other reason).
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
rhNRG-1
Experimental
recombinant human neuregulin-1
干预措施: rhNRG-1 (Drug)
结局指标
主要结局
cardiac function measured by MRI
时间窗: 30 days
次要结局
- cardiac function(baseline, 30 days, 90day and180 days)
研究者
研究点 (4)
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