Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01541202
Other study ID # ZS-01-305
Secondary ID
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03597646 - The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure N/A
Terminated NCT04065997 - Apogee International
Withdrawn NCT03675113 - Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure N/A
Completed NCT02916160 - Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study Phase 4
Completed NCT03126656 - Effects of Testosterone on Myocardial Repolarization Phase 4
Completed NCT02247245 - The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients. N/A
Completed NCT02268500 - VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT) Phase 4
Terminated NCT01906957 - Cognition and Exercise Training N/A
Completed NCT01919918 - Muscle Afferent Feedback Effects in Patients With Heart Failure Phase 1
Not yet recruiting NCT01669395 - Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial N/A
Completed NCT00984529 - Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia N/A
Recruiting NCT00863421 - Sleep Disordered Breathing in Patients With Chronic Heart Failure N/A
Completed NCT02840565 - Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 Phase 1
Completed NCT02441218 - Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study Phase 3
Completed NCT00149409 - Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure Phase 2/Phase 3
Terminated NCT05532046 - A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT) Phase 1
Recruiting NCT04984928 - Readmission Risk of Patients With Heart Failure.
Completed NCT02814097 - A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction Phase 2
Active, not recruiting NCT05560737 - ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
Recruiting NCT03286127 - Palliative Outcome Evaluation Muenster I