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

NCT ID: NCT01214096

Last Updated: 2017-12-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-01-31

Brief Summary

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

Detailed 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

Conditions

Chronic Heart Failure

Keywords

Chronic Heart failure; rhNRG-1; MRI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Subcutaneous Administration:0.6 or 1.2ug/kg/day for 10days

rhNRG-1

recombinant human neuregulin-1

Group Type: EXPERIMENTAL

rhNRG-1

Intervention Type: DRUG

Subcutaneous Administration:0.6ug/kg/day for 10days

rhNRG-1

Intervention Type: DRUG

Subcutaneous Administration 1.2ug/kg/day for 10 days

rhNRG-1

Intervention Type: DRUG

Vein infusion:0.6ug/kg/day for 10 days

Interventions

rhNRG-1

Subcutaneous Administration:0.6ug/kg/day for 10days

Intervention Type: DRUG

rhNRG-1

Subcutaneous Administration 1.2ug/kg/day for 10 days

Intervention Type: DRUG

rhNRG-1

Vein infusion:0.6ug/kg/day for 10 days

Intervention Type: DRUG

placebo

Subcutaneous Administration:0.6 or 1.2ug/kg/day for 10days

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zensun Sci. & Tech. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Runlin Gao

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Institute and Fuwai Hospital

Locations

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, , China

Countries

China

Other Identifiers

ZS-01-302

Identifier Type: -

Identifier Source: org_study_id