NCT01541202终止3 期
A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure
Zensun Sci. & Tech. Co., Ltd.46 个研究点 分布在 1 个国家目标入组 679 人开始时间: 2012年2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
- 679
- 试验地点
- 46
- 主要终点
- All-cause mortality
研究概览
简要总结
The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
详细描述
The mortality of chronic heart failure patients remains high, in spite of current treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function, reverse the remodeling of left ventricular, and reduce all-cause mortality in heart failure animals and humans. In this phase III study, the investigators will further confirm the efficacy of rhNRG-1 in reducing the death rate of heart failure.
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 between 18 and 75, both sex.
- •Left ventricular ejection fraction (LVEF)≤40% (ECHO).
- •NYNA functional class II OR III.
- •Diagnosed as chronic systolic heart failure (history, symptoms, signs), no in-hospital history in the last one month.
- •Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for the last one month.
- •Capable of signing the informed consent form.
排除标准
- •new chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.
- •NYNA functional class I OR IV.
- •Patients with acute MI, hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.
- •Ischemic heart failure without recanalization or with recanalization in recent six months.
- •acute MI in the last 3 months.
- •unstable angina.
- •Patients with acute pulmonary edema or acute hemodynamic disorder.
- •Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month.
- •Patients with right heart failure caused by pulmonary disease.
- •Patients diagnosed with pericardial effusion or pleural effusion, or evidenced by B-type ultrasonic (>50ml).
- •Cardiac surgery or cerebrovascular accident within recent six months.
- •Preparing for heart transplantation or CRT, or has received CRT.
- •Serious ventricular arrhythmia (multi-morphological premature ventricular contraction more than 5 times/min, frequent paroxysmal ventricular tachycardia or triple rate).
- •Serious hepatic or renal dysfunction (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
- •Serum potassium <3.2 mmol/L or >5.5 mmol/L.
- •Systolic blood pressure <90mmHg or >160mmHg.
- •Pregnant or plan to pregnant.
- •Patients who participated in any clinical trial in the recent three months.
- •Subject with a life expectancy less than 6 months as assessed by the investigator.
- •Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute.
- •History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
- •Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
- •Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
研究组 & 干预措施
Placebo
Placebo Comparator
placebo in addition to standard therapy
干预措施: Placebo (Drug)
rhNRG-1
Experimental
rhNRG-1 in addition to standard therapy
干预措施: rhNRG-1 (Drug)
结局指标
主要结局
All-cause mortality
时间窗: 1 year
次要结局
- death caused by cardiovascular events(1 year)
- rehospitalization(1 year)
- hospitalization caused by worsening heart failure(1 year)
- cardiac function(1 year)
- sudden death(1 year)
- NYHA functional classification(1 year)
- 6 minute walking distance(1 year)
- quality of life(1 year)
研究者
研究点 (46)
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