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

Sponsor

Zensun Sci. & Tech. Co., Ltd. (Industry)

Overall Status

Terminated

CT.gov ID

NCT01214096

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

3.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Drug: rhNRG-1 Drug: rhNRG-1 Drug: rhNRG-1 Drug: placebo	Phase 3

Detailed Description

Subcutaneous Administration of NRG-1 is well tolerated by CHF patients
Subcutaneous Administration of NRG-1 improves the cardiac function of CHF patients
Assessment of relative bioavailability of NRG-1 by Subcutaneous Administration

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo	Drug: placebo Subcutaneous Administration:0.6 or 1.2ug/kg/day for 10days
Experimental: rhNRG-1 recombinant human neuregulin-1	Drug: rhNRG-1 Subcutaneous Administration:0.6ug/kg/day for 10days Drug: rhNRG-1 Subcutaneous Administration 1.2ug/kg/day for 10 days Drug: rhNRG-1 Vein infusion:0.6ug/kg/day for 10 days

Arm

Intervention/Treatment

Placebo Comparator: placebo

Drug: placebo

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

Experimental: rhNRG-1

recombinant human neuregulin-1

Drug: rhNRG-1

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

Drug: rhNRG-1

Subcutaneous Administration 1.2ug/kg/day for 10 days

Drug: rhNRG-1

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

Outcome Measures

Primary Outcome Measures

cardiac function measured by MRI [30 days]

Secondary Outcome Measures

cardiac function [baseline, 30 days, 90day and180 days]
6-minute walk test, cardiac function classification(NYHA)，life quality score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: 18-75 years old, no limitation in gender;
Left ventricular ejection fraction (LVEF) ≤ 40% (ECHO);
Patients with chronic heart failure (NYHA class II or III);
In the past one month, the clinical condition (including history, clinical symptoms and signs) was relatively stable;
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;
Understand and sign the informed consent form;

Exclusion Criteria:

Atrial fibrillation;
Subject underwent cardiac pacemaker treatment;
Subject underwent metal graft treatment;
Claustrophobia;
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;
Ischemic heart failure without the revascularization or undergone the revascularization within last 6 months;
Subject underwent cardiac surgery or cerebrovascular events within the previous six months;
Subjects who plan to have cardiac transplantation;
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);
Subject needs mechanical ventilation;
Systolic blood pressure < 90mmHg, or > 160mmHg;
Chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation within last 1 month;
Mobitz Type II or III° atrial ventricular block，severe ventricular arrhythmia (polymorphic and frequent premature ventricular beats, frequent non-sustained ventricular tachycardia);
Serum potassium<3.2mmol/L, or>5.5mmol/L;
Female subject is pregnant or plan to become pregnant
Childbearing-aged female subject who is unmarried or dose not bear child;
Subject with life expectancy less than 6 months as assessed by investigators;
Subject participated in any other clinical trial within the previous three months;
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)
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);
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).

Contacts and Locations

Locations

	Site	City	Country
1	Beijing Anzhen Hospital of Capital University of Medical Sciences	Beijing	China
2	Beijing Chaoyang Hospital, Capital Medical University	Beijing	China
3	Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences	Beijing	China
4	General Hospital of People's Liberation Army	Beijing	China