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

Chronic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01131637
• Other study ID #: ZS-01-301
• Status: Terminated
• Phase: Phase 3
• First received: May 25, 2010
• Last updated: December 19, 2017
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: July 2012
• Source: Zensun Sci. & Tech. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 331
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 80, both sex.

2. Left ventricular ejection fraction (LVEF)=40% (ECHO).

3. NYNA functional class III~?.

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).

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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
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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zensun Sci. & Tech. Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		one year