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

Primary Purpose

Chronic Heart Failure

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
rhNRG-1
Placebo
Sponsored by
Zensun Sci. & Tech. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring chronic heart failure, neuregulin, mortality

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 18 and 75, both sex.
  2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
  3. NYNA functional class II OR III.
  4. Diagnosed as chronic systolic heart failure (history, symptoms, signs), no in-hospital history in the last one month.
  5. Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for the last one month.
  6. Capable of signing the informed consent form.

Exclusion Criteria:

  1. new chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.
  2. NYNA functional class I OR IV.
  3. Patients with acute MI, hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.
  4. Ischemic heart failure without recanalization or with recanalization in recent six months.
  5. acute MI in the last 3 months.
  6. unstable angina.
  7. Patients with acute pulmonary edema or acute hemodynamic disorder.
  8. Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month.
  9. Patients with right heart failure caused by pulmonary disease.
  10. Patients diagnosed with pericardial effusion or pleural effusion, or evidenced by B-type ultrasonic (>50ml).
  11. Cardiac surgery or cerebrovascular accident within recent six months.
  12. Preparing for heart transplantation or CRT, or has received CRT.
  13. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction more than 5 times/min, frequent paroxysmal ventricular tachycardia or triple rate).
  14. Serious hepatic or renal dysfunction (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
  15. Serum potassium <3.2 mmol/L or >5.5 mmol/L.
  16. Systolic blood pressure <90mmHg or >160mmHg.
  17. Pregnant or plan to pregnant.
  18. Patients who participated in any clinical trial in the recent three months.
  19. Subject with a life expectancy less than 6 months as assessed by the investigator.
  20. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute.
  21. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
  22. 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.
  23. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).

Sites / Locations

  • Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
  • Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
  • Beijing Xuanwu hospital of Capital Medical University
  • Cardiovascular Institute and Fuwai Hospital
  • General Hospital of Chinese People's Liberation Army
  • Peking University First Hospital
  • The Xinqiao Hospital of Third Military Medical University
  • Fujian Provincial Hospital
  • Guangdong Provincial People's Hospital
  • The First Affiliated Hospital, Sun Yet-Sen University
  • Haikou Municipal Peoples Hospital
  • Bethune Peace Hospital
  • Teda International Cardiovascular Hospital
  • Daqing Oilfield General Hospital
  • The First Hospital of Harbin Medical University
  • The First hospital affiliated to Zhengzhou University
  • Tongji Hospital Affiliated to Huazhong University of Science and Technology
  • People's Hospital of Hunan Province
  • The Second Xiangya Hospital of Central South University
  • Nanjing Drum Tower Hospital
  • Zhongda Hospital, Southeast University
  • The Second Hospital affiliated to Suzhou University
  • The Affiliated Hospital of Xuzhou Medical School
  • North Jiangsu People's Hospital
  • The Affiliate Hospital of Jiangsu University
  • The Second Hospital affiliated to Jilin University
  • The First Hospital affiliated to Dalian Medical University
  • The first affiliated hospital of Liaoning medical college
  • The First Hospital of China Medical College
  • Liaoning Provincial People's Hospital
  • Shengjing Hospital of China Medical University
  • Qilu Hospital of Shandong University
  • The Second Hospital of Shandong University
  • Huashan Hospital affiliated to Fudan University
  • Renji Hospital, Medical School of Shanghai Jiaotong University
  • Ruijin Hospital, Medical School of Shanghai Jiaotong University
  • The first people's hospitial of Shanghai
  • The Sixth People's Hospital, Shanghai Jiaotong University
  • The Second Hospital of Shanxi Medical College
  • The second hospital of Xi'an jiaotong university
  • Huaxi Hospital of Sichuan University
  • Sichuan Provincial People's Hospital
  • Kunming General Hospital of Chengdu Military Region
  • The Second Hospital of Kunming Medical College
  • Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University
  • The First Hospital affiliated to School of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

rhNRG-1

Arm Description

placebo in addition to standard therapy

rhNRG-1 in addition to standard therapy

Outcomes

Primary Outcome Measures

All-cause mortality

Secondary Outcome Measures

sudden death
death caused by cardiovascular events
rehospitalization
hospitalization caused by worsening heart failure
cardiac function
NYHA functional classification
6 minute walking distance
quality of life

Full Information

First Posted
February 23, 2012
Last Updated
December 19, 2017
Sponsor
Zensun Sci. & Tech. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01541202
Brief Title
Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
Sponsor has designed another study to replace the current study
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zensun Sci. & Tech. Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
Detailed Description
The mortality of chronic heart failure patients remains high, in spite of current 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, reverse the remodeling of left ventricular, and reduce all-cause mortality in heart failure animals and humans. In this phase III study, the investigators will further confirm the efficacy of rhNRG-1 in reducing the death rate of heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, neuregulin, mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
679 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo in addition to standard therapy
Arm Title
rhNRG-1
Arm Type
Experimental
Arm Description
rhNRG-1 in addition to standard therapy
Intervention Type
Drug
Intervention Name(s)
rhNRG-1
Intervention Description
10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
1 year
Secondary Outcome Measure Information:
Title
sudden death
Time Frame
1 year
Title
death caused by cardiovascular events
Time Frame
1 year
Title
rehospitalization
Time Frame
1 year
Title
hospitalization caused by worsening heart failure
Time Frame
1 year
Title
cardiac function
Time Frame
1 year
Title
NYHA functional classification
Time Frame
1 year
Title
6 minute walking distance
Time Frame
1 year
Title
quality of life
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 75, both sex. Left ventricular ejection fraction (LVEF)≤40% (ECHO). NYNA functional class II OR III. Diagnosed as chronic systolic heart failure (history, symptoms, signs), no in-hospital history in the last one month. Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for the last one month. Capable of signing the informed consent form. Exclusion Criteria: new chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months. NYNA functional class I OR IV. Patients with acute MI, hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension. Ischemic heart failure without recanalization or with recanalization in recent six months. acute MI in the last 3 months. unstable angina. Patients with acute pulmonary edema or acute hemodynamic disorder. Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month. Patients with right heart failure caused by pulmonary disease. Patients diagnosed with pericardial effusion or pleural effusion, or evidenced by B-type ultrasonic (>50ml). Cardiac surgery or cerebrovascular accident within recent six months. Preparing for heart transplantation or CRT, or has received CRT. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction more than 5 times/min, frequent paroxysmal ventricular tachycardia or triple rate). Serious hepatic or renal dysfunction (Cr>2.0mg/dl, AST or ALT 5 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 6 months as assessed by the investigator. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Runlin Gao, MD, Ph.D
Organizational Affiliation
Cardiovascular Institute and Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Xuanwu hospital of Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Cardiovascular Institute and Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
General Hospital of Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Xinqiao Hospital of Third Military Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital, Sun Yet-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Haikou Municipal Peoples Hospital
City
Haikou
State/Province
Hainan
Country
China
Facility Name
Bethune Peace Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Teda International Cardiovascular Hospital
City
Tianjin
State/Province
Hebei
Country
China
Facility Name
Daqing Oilfield General Hospital
City
Daqing
State/Province
Heilongjiang
Country
China
Facility Name
The First Hospital of Harbin Medical University
City
Haerbin
State/Province
Heilongjiang
Country
China
Facility Name
The First hospital affiliated to Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Tongji Hospital Affiliated to Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
People's Hospital of Hunan Province
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Zhongda Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The Second Hospital affiliated to Suzhou University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical School
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
North Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
The Affiliate Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
Facility Name
The Second Hospital affiliated to Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The First Hospital affiliated to Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The first affiliated hospital of Liaoning medical college
City
Jinzhou
State/Province
Liaoning
Country
China
Facility Name
The First Hospital of China Medical College
City
Shengyang
State/Province
Liaoning
Country
China
Facility Name
Liaoning Provincial People's Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
The Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Huashan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Renji Hospital, Medical School of Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Ruijin Hospital, Medical School of Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The first people's hospitial of Shanghai
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The Sixth People's Hospital, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The Second Hospital of Shanxi Medical College
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
The second hospital of Xi'an jiaotong university
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Huaxi Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Kunming General Hospital of Chengdu Military Region
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
The Second Hospital of Kunming Medical College
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Hospital affiliated to School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

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

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