Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic Heart Failure Patients
Primary Purpose
Chronic Systolic Heart Failure
Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
rhNRG-1
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Systolic Heart Failure focused on measuring Chronic heart failure, rhNRG-1, Cardiac remodeling
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 75, both sex.
- Left ventricular ejection fraction (LVEF)≤40% (ECHO).
- NYNA functional class II~III.
- Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
- Receiving standard basic treatment of heart failure, has reached the objective dosage or the highest tolerated dosage for at least 1 month, or the dosage has not been changed for at least 1 month.
- Capable of signing the informed consent form.
Exclusion Criteria:
- Patients with atrial fibrillation.
- Patients with a pacemaker.
- Patient with a metallic implant.
- Patient with Claustrophobia.
- Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
- Ischemic heart failure without recanalization or with recanalization in recent six months.
- Cardiac surgery or cerebrovascular accident within recent six months.
- Preparing for heart transplantation or has received CRT treatment.
- Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
- Patients need mechanical ventilation.
- Systolic blood pressure <90mmHg or >160mmHg.
- Patients with acute hemodynamic disorder or decompensation in the last 1 month.
- Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
- Serum potassium <3.2 mmol/L or >5.5 mmol/L.
- Pregnant or plan to pregnant.
- Unmarried or married but not procreated women at child-bearing age.
- Subject with a life expectancy less than 6 months as assessed by the investigator.
- Patients who participated in any clinical trial in the recent three months.
- History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
- Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
- Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
Sites / Locations
- Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
- Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
- Cardiovascular Institute and Fuwai Hospital
- General Hospital of Chinese People's Liberation Army
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
rhNRG-1
Placebo
Arm Description
Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure
Excipient placebo in addition to basic therapy of chronic heart failure
Outcomes
Primary Outcome Measures
Left Ventricular Ejection Fraction
Secondary Outcome Measures
Left Ventricular Ejection Fraction
N-terminal pro-BNP
Full Information
NCT ID
NCT01439893
First Posted
September 21, 2011
Last Updated
December 19, 2017
Sponsor
Zensun Sci. & Tech. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01439893
Brief Title
Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic Heart Failure Patients
Official Title
A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Efficacy/Safety of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Sponsor has designed another study with different endpoint to replace the current study
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (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
This is a multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on cardiac remodeling, as well as safety in patients with chronic heart failure.
Detailed Description
RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it.Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively improved the heart function, and is tolerated in the effective dosage groups. The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively improve the cardiac remodeling and is tolerated in patients with chronic heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Systolic Heart Failure
Keywords
Chronic heart failure, rhNRG-1, Cardiac remodeling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rhNRG-1
Arm Type
Active Comparator
Arm Description
Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Excipient placebo in addition to basic therapy of chronic heart failure
Intervention Type
Drug
Intervention Name(s)
rhNRG-1
Intervention Description
day1~day10:0.6ug/kg/day,10hours per day for vein infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
day1~day10:0.6ug/kg/day,10hours per day for vein infusion
Primary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction
Time Frame
90 days
Title
N-terminal pro-BNP
Time Frame
30 days and 90 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 between 18 and 75, both sex.
Left ventricular ejection fraction (LVEF)≤40% (ECHO).
NYNA functional class II~III.
Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
Receiving standard basic treatment of heart failure, has reached the objective dosage or the highest tolerated dosage for at least 1 month, or the dosage has not been changed for at least 1 month.
Capable of signing the informed consent form.
Exclusion Criteria:
Patients with atrial fibrillation.
Patients with a pacemaker.
Patient with a metallic implant.
Patient with Claustrophobia.
Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
Ischemic heart failure without recanalization or with recanalization in recent six months.
Cardiac surgery or cerebrovascular accident within recent six months.
Preparing for heart transplantation or has received CRT treatment.
Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
Patients need mechanical ventilation.
Systolic blood pressure <90mmHg or >160mmHg.
Patients with acute hemodynamic disorder or decompensation in the last 1 month.
Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
Serum potassium <3.2 mmol/L or >5.5 mmol/L.
Pregnant or plan to pregnant.
Unmarried or married but not procreated women at child-bearing age.
Subject with a life expectancy less than 6 months as assessed by the investigator.
Patients who participated in any clinical trial in the recent three months.
History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Runlin Gao, MD, Ph.D
Organizational Affiliation
Cardiovascular Institute and Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Cardiovascular Institute and Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
General Hospital of Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic Heart Failure Patients
We'll reach out to this number within 24 hrs