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

Purpose

The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of 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 Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Zensun Sci. & Tech. Co., Ltd.:

Primary Outcome Measures:

all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	331
Study Start Date:	April 2010
Estimated Study Completion Date:	December 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: rhNRG-1 recombinant human neuregulin-1	Drug: rhNRG-1 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
Placebo Comparator: placebo placebo	Drug: placebo 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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131637

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Locations

China, Beijing
General Hospital of Chinese People's Liberation Army
Beijing, Beijing, China
China, Gansu
The First Hospital affiliated to Lanzhou University
Lanzhou, Gansu, China
China, Hainan
Haikou Municipal Peoples Hospital
Haikou, Hainan, China
China, Hebei
Bethune International 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 hospital affiliated to Zhengzhou University
Zhengzhou, Henan, China
China, Hubei
Zhongnan Hospital of Wuhan University
Wuchang, Hubei, China
Tongji Hospital Affiliated to Huazhong University of Science and Technology
Wuhan, Hubei, China
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Provincial People`s Hospital
Changsha, Hunan, China
China, Jiangsu
Jiangsu Jiangyin People's Hospital
Jiangyin, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
The Second Hospital affiliated to Suzhou University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical School
Xuzhou, Jiangsu, China
North Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The Affiliate Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
China, Jilin
The Second Hospital affiliated to 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
The First Hospital of China Medical Hospital
Shenyang, Liaoning, China
China, Shandong
The Second Hospital of Shandong University
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
China, Shanxi
The second hospital of Xi'an jiaotong university
Xi'an, Shanxi, China
Shanxi Provincial People's Hospital
Xi'an, Shanxi, China
China, Sichuan
Huaxi Hospital of Sichuan University
Chendu, Sichuan, China
Sichuan Provincial People`s Hospital
Chendu, Sichuan, China
The Xinqiao Hospital of Third Military Medical University
Chongqin, Sichuan, China
China, Yunnan
The Second hospital affiliated to Kunming Medical and Pharmaceutical College
Kunming, Yunnan, China
Kunming General Hospital of Chengdu Military Region
Kunming, Yunnan, China
China, Zhejiang
The First Hospital affiliated to School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
China
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
Beijing, China
Cardiovascular Institute and Fuwai Hospital
Beijing, China
Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
Beijing, China
The Sixth People's Hospital, Shanghai Jiaotong University
Shanghai, China
Huashan Hospital affiliated to Fudan University
Shanghai, China
The first people's hospitial of Shanghai
Shanghai, China
Renji Hospital, Medical School of Shanghai Jiaotong University
Shanghai, China

Sponsors and Collaborators

Zensun Sci. & Tech. Co., Ltd.

Investigators

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:	NCT01131637 History of Changes
Other Study ID Numbers:	ZS-01-301
Study First Received:	May 25, 2010
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
mortality

Additional relevant MeSH terms:

Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013