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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01214096
Recruitment Status : Terminated (The same protocol has been launched in United States.)
First Posted : October 4, 2010
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Zensun Sci. & Tech. Co., Ltd.

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: placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
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 : July 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. cardiac function measured by MRI [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. cardiac function [ Time Frame: baseline, 30 days, 90day and180 days ]
    6-minute walk test, cardiac function classification(NYHA),life quality score.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214096


Locations
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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, China
Sponsors and Collaborators
Zensun Sci. & Tech. Co., Ltd.
Investigators
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Principal Investigator: Runlin Gao Cardiovascular Institute and Fuwai Hospital

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Responsible Party: Zensun Sci. & Tech. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01214096     History of Changes
Other Study ID Numbers: ZS-01-302
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: November 2017

Keywords provided by Zensun Sci. & Tech. Co., Ltd.:
Chronic Heart failure
rhNRG-1
MRI

Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases