Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind , Placebo Parallel Controlled, Standard Therapy Based Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01214096
• Other study ID #: ZS-01-302
• Status: Terminated
• Phase: Phase 3
• First received: September 28, 2010
• Last updated: December 19, 2017
• Start date: July 2010
• Est. completion date: January 2011

Study information

• Verified date: November 2017
• Source: Zensun Sci. & Tech. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure

Description:

1. Subcutaneous Administration of NRG-1 is well tolerated by CHF patients

2. Subcutaneous Administration of NRG-1 improves the cardiac function of CHF patients

3. Assessment of relative bioavailability of NRG-1 by Subcutaneous Administration

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age: 18-75 years old, no limitation in gender;

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

3. Patients with chronic heart failure (NYHA class II or III);

4. In the past one month, the clinical condition (including history, clinical symptoms and signs) was relatively stable;

5. Patients on standard treatment of chronic heart failure at the target dose or maximum tolerance dose for over 1 month ,or unchanged dose in last 1 month;

6. Understand and sign the informed consent form;

Exclusion Criteria:

1. Atrial fibrillation;

2. Subject underwent cardiac pacemaker treatment;

3. Subject underwent metal graft treatment;

4. Claustrophobia;

5. Acute myocardial infarction, cardiac ischemia indicated by 6-minute walk test, hypertrophic cardiomyopathy, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension;

6. Ischemic heart failure without the revascularization or undergone the revascularization within last 6 months;

7. Subject underwent cardiac surgery or cerebrovascular events within the previous six months;

8. Subjects who plan to have cardiac transplantation;

9. Severe hepatic and renal insufficiency (serum creatinine>2.0 mg /dl, AST or ALT is five times higher than the upper limit of normal range);

10. Subject needs mechanical ventilation;

11. Systolic blood pressure < 90mmHg, or > 160mmHg;

12. Chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation within last 1 month;

13. Mobitz Type II or III° atrial ventricular block,severe ventricular arrhythmia (polymorphic and frequent premature ventricular beats, frequent non-sustained ventricular tachycardia);

14. Serum potassium<3.2mmol/L, or>5.5mmol/L;

15. Female subject is pregnant or plan to become pregnant

16. Childbearing-aged female subject who is unmarried or dose not bear child;

17. Subject with life expectancy less than 6 months as assessed by investigators;

18. Subject participated in any other clinical trial within the previous three months;

19. Subject with previous history of tumor, or current tumor patient, or subject with pre-cancerous disease manifested by pathological examination (such as ductal carcinoma in situ or cervical epithelial dysplasia)

20. Examinations (physical examination, X-ray examination, type-B ultrasonic detection or other methods) reveal that the subject has malignant mass, gland hyperplasia or adenoma with endocrine activity, or impact on heart, or endocrine function (such as pheochromocytoma, thyroid enlargement);

21. The Investigator deemed for whatever reason that the subject is not likely to complete the study or comply with the study procedures (due to administration or any other reason).

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Heart Failure, Systolic

Intervention

Drug:
• rhNRG-1
Subcutaneous Administration:0.6ug/kg/day for 10days
• rhNRG-1
Subcutaneous Administration 1.2ug/kg/day for 10 days
• rhNRG-1
Vein infusion:0.6ug/kg/day for 10 days
• placebo
Subcutaneous Administration:0.6 or 1.2ug/kg/day for 10days

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital of Capital University of Medical Sciences	Beijing
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing
China	Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences	Beijing
China	General Hospital of People's Liberation Army	Beijing

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	cardiac function measured by MRI		30 days
Secondary	cardiac function	6-minute walk test, cardiac function classification(NYHA),life quality score.	baseline, 30 days, 90day and180 days