Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic Heart Failure Patients
NCT ID: NCT01439893
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
14 participants
INTERVENTIONAL
2011-06-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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rhNRG-1
Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure
rhNRG-1
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion
Placebo
Excipient placebo in addition to basic therapy of chronic heart failure
Placebo
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion
Interventions
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rhNRG-1
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion
Placebo
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion
Eligibility Criteria
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Inclusion Criteria
2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
3. NYNA functional class II\~III.
4. Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
5. 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.
6. Capable of signing the informed consent form.
Exclusion Criteria
2. Patients with a pacemaker.
3. Patient with a metallic implant.
4. Patient with Claustrophobia.
5. Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
6. Ischemic heart failure without recanalization or with recanalization in recent six months.
7. Cardiac surgery or cerebrovascular accident within recent six months.
8. Preparing for heart transplantation or has received CRT treatment.
9. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr\>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
10. Patients need mechanical ventilation.
11. Systolic blood pressure \<90mmHg or \>160mmHg.
12. Patients with acute hemodynamic disorder or decompensation in the last 1 month.
13. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
14. Serum potassium \<3.2 mmol/L or \>5.5 mmol/L.
15. Pregnant or plan to pregnant.
16. Unmarried or married but not procreated women at child-bearing age.
17. Subject with a life expectancy less than 6 months as assessed by the investigator.
18. Patients who participated in any clinical trial in the recent three months.
19. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
20. 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.
21. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
18 Years
75 Years
ALL
No
Sponsors
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Zensun Sci. & Tech. Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Runlin Gao, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Institute and Fuwai Hospital
Locations
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Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
Beijing, Beijing Municipality, China
Cardiovascular Institute and Fuwai Hospital
Beijing, Beijing Municipality, China
General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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ZS-01-303
Identifier Type: -
Identifier Source: org_study_id