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: NCT01541202
• Other study ID #: ZS-01-305
• Status: Terminated
• Phase: Phase 3
• First received: February 23, 2012
• Last updated: December 19, 2017
• Start date: February 2012
• Est. completion date: August 2017

Study information

• Verified date: February 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 679
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• rhNRG-1
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
• Placebo
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

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences	Beijing	Beijing
China	Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences	Beijing	Beijing
China	Beijing Xuanwu hospital of Capital Medical University	Beijing	Beijing
China	Cardiovascular Institute and Fuwai Hospital	Beijing	Beijing
China	General Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The Second Hospital affiliated to Jilin University	Changchun	Jilin
China	People's Hospital of Hunan Province	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Huaxi Hospital of Sichuan University	Chengdu	Sichuan
China	Sichuan Provincial People`s Hospital	Chengdu	Sichuan
China	The Xinqiao Hospital of Third Military Medical University	Chongqing	Chongqing
China	The First Hospital affiliated to Dalian Medical University	Dalian	Liaoning
China	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yet-Sen University	Guangzhou	Guangdong
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	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 of Kunming Medical College	Kunming	Yunnan
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu
China	Huashan Hospital affiliated to Fudan University	Shanghai	Shanghai
China	Renji Hospital, Medical School of Shanghai Jiaotong University	Shanghai	Shanghai
China	Ruijin Hospital, Medical School of Shanghai Jiaotong University	Shanghai	Shanghai
China	The first people's hospitial of Shanghai	Shanghai	Shanghai
China	The Sixth People's Hospital, Shanghai Jiaotong University	Shanghai	Shanghai
China	The First Hospital of China Medical College	Shengyang	Liaoning
China	Liaoning Provincial People's Hospital	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Bethune Peace Hospital	Shijiazhuang	Hebei
China	The Second Hospital affiliated to Suzhou University	Suzhou	Jiangsu
China	The Second Hospital of Shanxi Medical College	Taiyuan	Shanxi
China	Teda International Cardiovascular Hospital	Tianjin	Hebei
China	Tongji Hospital Affiliated to Huazhong University of Science and Technology	Wuhan	Hubei
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		1 year
Secondary	sudden death		1 year
Secondary	death caused by cardiovascular events		1 year
Secondary	rehospitalization		1 year
Secondary	hospitalization caused by worsening heart failure		1 year
Secondary	cardiac function		1 year
Secondary	NYHA functional classification		1 year
Secondary	6 minute walking distance		1 year
Secondary	quality of life		1 year