Study of Efficacy on NT-proBNP of Recombinant Human Neuregulin-1 in Chronic Heart Failure Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

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 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: rhNRG-1<br>Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure | Drug: rhNRG-1<br>* day1 day10:0.6ug/kg/day,10hours per day for vein infusion<br>|
| Placebo Comparator: Plaebo<br>Excipient placebo in addition to basic therapy of chronic heart failure | Drug: Placebo<br>* day1 day10:0.6ug/kg/day,10hours per day for vein infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-proBNP |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Heart Failure, rhNRG-1, NT-proBNP