A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Efficacy/Safety of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 146
- 试验地点
- 21
- 主要终点
- NT-proBNP
研究概览
简要总结
Multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on serum NT-proBNP, as well as safety in patients with chronic heart failure.
详细描述
N-terminal proNBP (NT-proBNP) has been proved to be an independent prognostic factor for the long-term prognosis of chronic heart failure patients.RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it. It has been found that rhNRG-1 effectively decreased the serum level of NT-proBNP,and is tolerated in the effective dosages groups.The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively decrease the serum level of NT-proBNP and is tolerated in patients with chronic 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~III.
- •Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
- •Receiving standard basic treatment of heart failure, has reached the objective dosage or the highest tolerated dosage for at least 1 month, or the dosage has not been changed for at least 1 month.
- •Capable of signing the informed consent form.
排除标准
- •Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
- •Ischemic heart failure without recanalization or with recanalization in recent six months.
- •Cardiac surgery or cerebrovascular accident within recent six months.
- •Preparing for heart transplantation or has received CRT treatment.
- •Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
- •Patients need mechanical ventilation.
- •Systolic blood pressure <90mmHg or >160mmHg.
- •Patients with acute hemodynamic disorder or decompensation in the last 1 month.
- •Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
- •Serum potassium <3.2 mmol/L or >5.5 mmol/L.
- •Pregnant or plan to pregnant.
- •Unmarried or married but not procreated women at child-bearing age.
- •Subject with a life expectancy less than 6 months as assessed by the investigator.
- •Patients who participated in any clinical trial in the recent three months.
- •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
rhNRG-1
Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure
干预措施: rhNRG-1 (Drug)
Plaebo
Excipient placebo in addition to basic therapy of chronic heart failure
干预措施: Placebo (Drug)
结局指标
主要结局
NT-proBNP
时间窗: 30 days
次要结局
- NT-proBNP(90 days)
- Six Minutes Walk Distance(30 days and 90 days)
- NYHA classification(30 days and 90 days)
- Quality of Life(30 days and 90 days)