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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, rhNRG-1, mortality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 18 and 80, both sex.
  2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
  3. NYNA functional class III~Ⅳ.
  4. Clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain).
  5. Capable of signing the informed consent form.

Exclusion Criteria:

  1. Patients with acute pulmonary edema or acute hemodynamic disorder.
  2. Patients with right heart failure caused by pulmonary disease.
  3. Patients diagnosed with pericardial effusion or pleural effusion.
  4. Patients with myocardial infarction during the preceding 3 months.
  5. Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
  6. Unstable angina pectoris.
  7. Cardiac surgery or cerebrovascular accident within recent six months.
  8. Preparing for heart transplantation.
  9. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
  10. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>3.0mg/dl, AST or ALT 10 times above the normal upper limit).
  11. Serum potassium <3.2 mmol/L or >5.5 mmol/L.
  12. Systolic blood pressure <90mmHg or >160mmHg.
  13. Pregnant or plan to pregnant.
  14. Patients who participated in any clinical trial in the recent three months.
  15. Subject with a life expectancy less than 3 months as assessed by the investigator.
  16. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism).
  17. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
  18. 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.
  19. 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

  • General Hospital of Chinese People's Liberation Army
  • The First Hospital affiliated to Lanzhou University
  • Haikou Municipal Peoples Hospital
  • Bethune International Peace Hospital
  • Teda International Cardiovascular Hospital
  • Daqing Oilfield General Hospital
  • The First Hospital of Harbin Medical University
  • The First hospital affiliated to Zhengzhou University
  • Zhongnan Hospital of Wuhan University
  • Tongji Hospital Affiliated to Huazhong University of Science and Technology
  • Hunan Provincial People's Hospital
  • The Second Xiangya Hospital of Central South University
  • Jiangsu Jiangyin People's Hospital
  • 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
  • Liaoning Provincial People's Hospital
  • Shengjing Hospital of China Medical University
  • The First Hospital of China Medical Hospital
  • Qilu Hospital of Shandong University
  • The Second Hospital of Shandong University
  • Shanxi Provincial People's Hospital
  • The second hospital of Xi'an jiaotong university
  • Huaxi Hospital of Sichuan University
  • Sichuan Provincial People's Hospital
  • The Xinqiao Hospital of Third Military Medical University
  • Kunming General Hospital of Chengdu Military Region
  • The Second hospital affiliated to Kunming Medical and Pharmaceutical College
  • Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University
  • The First Hospital affiliated to School of Medicine, Zhejiang University
  • Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
  • Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
  • Cardiovascular Institute and Fuwai Hospital
  • Huashan Hospital affiliated to Fudan University
  • Renji Hospital, Medical School of Shanghai Jiaotong University
  • The first people's hospitial of Shanghai
  • The Sixth People's Hospital, Shanghai Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rhNRG-1

placebo

Arm Description

recombinant human neuregulin-1

placebo

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

Full Information

First Posted
May 25, 2010
Last Updated
December 19, 2017
Sponsor
Zensun Sci. & Tech. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01131637
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
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Sponsor has designed another study to replace the current study
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (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 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.

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, rhNRG-1, mortality

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
rhNRG-1
Arm Type
Experimental
Arm Description
recombinant human neuregulin-1
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
rhNRG-1
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
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
General Hospital of Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Hospital affiliated to Lanzhou University
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
Haikou Municipal Peoples Hospital
City
Haikou
State/Province
Hainan
Country
China
Facility Name
Bethune International 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
Zhongnan Hospital of Wuhan University
City
Wuchang
State/Province
Hubei
Country
China
Facility Name
Tongji Hospital Affiliated to Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Hunan Provincial People's Hospital
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
Jiangsu Jiangyin People's Hospital
City
Jiangyin
State/Province
Jiangsu
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
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
The First Hospital of China Medical Hospital
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
Shanxi Provincial People's Hospital
City
Xi'an
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
Chendu
State/Province
Sichuan
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chendu
State/Province
Sichuan
Country
China
Facility Name
The Xinqiao Hospital of Third Military Medical University
City
Chongqin
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 affiliated to Kunming Medical and Pharmaceutical 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
Facility Name
Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
City
Beijing
Country
China
Facility Name
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
City
Beijing
Country
China
Facility Name
Cardiovascular Institute and Fuwai Hospital
City
Beijing
Country
China
Facility Name
Huashan Hospital affiliated to Fudan University
City
Shanghai
Country
China
Facility Name
Renji Hospital, Medical School of Shanghai Jiaotong University
City
Shanghai
Country
China
Facility Name
The first people's hospitial of Shanghai
City
Shanghai
Country
China
Facility Name
The Sixth People's Hospital, Shanghai Jiaotong University
City
Shanghai
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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