Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
Primary Purpose
Chronic Heart Failure
Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
rhNRG-1
rhNRG-1
rhNRG-1
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart failure, rhNRG-1, MRI
Eligibility Criteria
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).
Sites / Locations
- Beijing Anzhen Hospital of Capital University of Medical Sciences
- Beijing Chaoyang Hospital, Capital Medical University
- Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences
- General Hospital of People's Liberation Army
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
rhNRG-1
Arm Description
recombinant human neuregulin-1
Outcomes
Primary Outcome Measures
cardiac function measured by MRI
Secondary Outcome Measures
cardiac function
6-minute walk test, cardiac function classification(NYHA),life quality score.
Full Information
NCT ID
NCT01214096
First Posted
September 28, 2010
Last Updated
December 19, 2017
Sponsor
Zensun Sci. & Tech. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01214096
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
The same protocol has been launched in United States.
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zensun Sci. & Tech. Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Chronic Heart failure, rhNRG-1, MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
rhNRG-1
Arm Type
Experimental
Arm Description
recombinant human neuregulin-1
Intervention Type
Drug
Intervention Name(s)
rhNRG-1
Intervention Description
Subcutaneous Administration:0.6ug/kg/day for 10days
Intervention Type
Drug
Intervention Name(s)
rhNRG-1
Intervention Description
Subcutaneous Administration 1.2ug/kg/day for 10 days
Intervention Type
Drug
Intervention Name(s)
rhNRG-1
Intervention Description
Vein infusion:0.6ug/kg/day for 10 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subcutaneous Administration:0.6 or 1.2ug/kg/day for 10days
Primary Outcome Measure Information:
Title
cardiac function measured by MRI
Time Frame
30 days
Secondary Outcome Measure Information:
Title
cardiac function
Description
6-minute walk test, cardiac function classification(NYHA),life quality score.
Time Frame
baseline, 30 days, 90day and180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Runlin Gao
Organizational Affiliation
Cardiovascular Institute and Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital of Capital University of Medical Sciences
City
Beijing
Country
China
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Name
General Hospital of People's Liberation Army
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
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