Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

Detailed Description
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The mortality of chronic heart failure patients remains high, in spite of recent 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 and reverse the remodeling of left ventricular in heart failure animals and humans. In this study, we will evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

Official Title
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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

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Drug: rhNRG-1
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 80, both sex. Left ventricular ejection fraction (LVEF)≤40% (ECHO). NYNA functional class III Ⅳ. Clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain). Capable of signing the informed consent form. Exclusion Criteria: Patients with acute pulmonary edema or acute hemodynamic disorder. Patients with right heart failure caused by pulmonary disease. Patients diagnosed with pericardial effusion or pleural effusion. Patients with myocardial infarction during the preceding 3 months. Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension. Unstable angina pectoris. Cardiac surgery or cerebrovascular accident within recent six months. Preparing for heart transplantation. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia). Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>3.0mg/dl, AST or ALT 10 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 3 months as assessed by the investigator. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism). 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhNRG-1<br>recombinant human neuregulin-1 | Drug: rhNRG-1<br>* day1 day10:0.6ug/kg/day,10hours per day for vein infusion; week3 week25:0.8ug/kg/day,10minutes per time per week for vein injection<br>|
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br>* day1 day10:0.6ug/kg/day,10hours per day for vein infusion; week3 week25:0.8ug/kg/day,10minutes per time per week for vein injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic heart failure, rhNRG-1, mortality