Clinical trial NCT01214096: Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Heart Failure
Keywords: Chronic Heart failure
rhNRG-1
MRI
Lead sponsor: Zensun Sci. & Tech. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-10-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Primary outcomes:
measure: cardiac function measured by MRI
timeFrame: 30 days
Secondary outcomes:
measure: cardiac function
timeFrame: baseline, 30 days, 90day and180 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital of Capital University of Medical Sciences
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
city: Beijing
country: China
facility: Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: General Hospital of People's Liberation Army
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital
name: Runlin Gao
role: PRINCIPAL_INVESTIGATOR
References: