Study of Efficacy on NT-proBNP of Recombinant Human Neuregulin-1 in Chronic Heart Failure Patients
- Conditions
- Chronic Heart Failure
- Interventions
- Drug: rhNRG-1Drug: Placebo
- Registration Number
- NCT01439789
- Lead Sponsor
- Zensun Sci. & Tech. Co., Ltd.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 146
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rhNRG-1 rhNRG-1 Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure Plaebo Placebo Excipient placebo in addition to basic therapy of chronic heart failure
- Primary Outcome Measures
Name Time Method NT-proBNP 30 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (21)
Cardiovascular Institute and Fuwai Hospital
🇨🇳Beijing, Beijing, China
Bethune Peace Hospital
🇨🇳Shijiazhuang, Hebei, China
Daqing Oilfield General Hospital
🇨🇳Daqing, Heilongjiang, China
The First Hospital of Harbin Medical University
🇨🇳Haerbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The Second Hospital affiliated to Suzhou University
🇨🇳Suzhou, Jiangsu, China
The First Hospital affiliated to Dalian Medical University
🇨🇳Dalian, Liaoning, China
The first affiliated hospital of Liaoning medical college
🇨🇳Jinzhou, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Kunming General Hospital of Chengdu Military Region
🇨🇳Kunming, Yunnan, China
Shanghai First People's Hospital
🇨🇳Shanghai, Shanghai, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghai, China
Teda International Cardiovascular Hospital
🇨🇳Tianjin, Hebei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Jiangsu, China
The Affiliate Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Liaoning Provincial People's Hospital
🇨🇳Shenyang, Liaoning, China
North Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Xinqiao Hospital of Third Military Medical University
🇨🇳Chongqing, Sichuan, China