Study of Efficacy on NT-proBNP of Recombinant Human Neuregulin-1 in Chronic Heart Failure Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Heart Failure |
Drug: rhNRG-1 Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
- NT-proBNP [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- NT-proBNP [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Six Minutes Walk Distance [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
- NYHA classification [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
| Enrollment: | 146 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: rhNRG-1
Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure
|
Drug: rhNRG-1
day1~day10:0.6ug/kg/day,10hours per day for vein infusion
|
|
Placebo Comparator: Plaebo
Excipient placebo in addition to basic therapy of chronic heart failure
|
Drug: Placebo
day1~day10:0.6ug/kg/day,10hours per day for vein infusion
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| China, Beijing | |
| Cardiovascular Institute and Fuwai Hospital | |
| Beijing, Beijing, China | |
| China, Hebei | |
| Bethune Peace Hospital | |
| Shijiazhuang, Hebei, China | |
| Teda International Cardiovascular Hospital | |
| Tianjin, Hebei, China | |
| China, Heilongjiang | |
| Daqing Oilfield General Hospital | |
| Daqing, Heilongjiang, China | |
| The First Hospital of Harbin Medical University | |
| Haerbin, Heilongjiang, China | |
| China, Henan | |
| The First Affiliated Hospital of Zhengzhou University | |
| Zhengzhou, Henan, China | |
| China, Hunan | |
| The Second Xiangya Hospital of Central South University | |
| Changsha, Hunan, China | |
| China, Jiangsu | |
| Sichuan Provincial People`s Hospital | |
| Chengdu, Jiangsu, China | |
| The Second Hospital affiliated to Suzhou University | |
| Suzhou, Jiangsu, China | |
| North Jiangsu People's Hospital | |
| Yangzhou, Jiangsu, China | |
| The Affiliate Hospital of Jiangsu University | |
| Zhenjiang, Jiangsu, China | |
| China, Jilin | |
| The Second Hospital of Jilin University | |
| Changchun, Jilin, China | |
| China, Liaoning | |
| The First Hospital affiliated to Dalian Medical University | |
| Dalian, Liaoning, China | |
| The first affiliated hospital of Liaoning medical college | |
| Jinzhou, Liaoning, China | |
| Shengjing Hospital of China Medical University | |
| Shenyang, Liaoning, China | |
| Liaoning Provincial People's Hospital | |
| Shenyang, Liaoning, China | |
| China, Shandong | |
| Qilu Hospital of Shandong University | |
| Jinan, Shandong, China | |
| China, Shanghai | |
| Shanghai First People's Hospital | |
| Shanghai, Shanghai, China | |
| Shanghai Sixth People's Hospital | |
| Shanghai, Shanghai, China | |
| China, Sichuan | |
| The Xinqiao Hospital of Third Military Medical University | |
| Chongqing, Sichuan, China | |
| China, Yunnan | |
| Kunming General Hospital of Chengdu Military Region | |
| Kunming, Yunnan, China | |
| Principal Investigator: | Runlin Gao, MD, Ph.D | Cardiovascular Institute and Fuwai Hospital |
More Information
No publications provided
| Responsible Party: | Zensun Sci. & Tech. Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01439789 History of Changes |
| Other Study ID Numbers: | ZS-01-304 |
| Study First Received: | September 21, 2011 |
| Last Updated: | August 1, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Zensun Sci. & Tech. Co., Ltd.:
|
Chronic Heart Failure rhNRG-1 NT-proBNP |
Additional relevant MeSH terms:
|
Heart Failure Heart Failure, Systolic Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013