Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-28 @ 6:24 PM
Study NCT ID:
NCT01541202
Status:
TERMINATED
Last Update Posted:
2017-12-21
First Post:
2012-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C565323', 'term': 'Fibromatosis, Gingival, 2'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 679}}, 'statusModule': {'whyStopped': 'Sponsor has designed another study to replace the current study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-19', 'studyFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'sudden death', 'timeFrame': '1 year'}, {'measure': 'death caused by cardiovascular events', 'timeFrame': '1 year'}, {'measure': 'rehospitalization', 'timeFrame': '1 year'}, {'measure': 'hospitalization caused by worsening heart failure', 'timeFrame': '1 year'}, {'measure': 'cardiac function', 'timeFrame': '1 year'}, {'measure': 'NYHA functional classification', 'timeFrame': '1 year'}, {'measure': '6 minute walking distance', 'timeFrame': '1 year'}, {'measure': 'quality of life', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic heart failure', 'neuregulin', 'mortality'], 'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.', 'detailedDescription': 'The mortality of chronic heart failure patients remains high, in spite of current treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function, reverse the remodeling of left ventricular, and reduce all-cause mortality in heart failure animals and humans. In this phase III study, the investigators will further confirm the efficacy of rhNRG-1 in reducing the death rate of heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age between 18 and 75, both sex.\n2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).\n3. NYNA functional class II OR III.\n4. Diagnosed as chronic systolic heart failure (history, symptoms, signs), no in-hospital history in the last one month.\n5. Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for the last one month.\n6. Capable of signing the informed consent form.\n\nExclusion Criteria:\n\n1. new chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.\n2. NYNA functional class I OR IV.\n3. Patients with acute MI, hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.\n4. Ischemic heart failure without recanalization or with recanalization in recent six months.\n5. acute MI in the last 3 months.\n6. unstable angina.\n7. Patients with acute pulmonary edema or acute hemodynamic disorder.\n8. Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month.\n9. Patients with right heart failure caused by pulmonary disease.\n10. Patients diagnosed with pericardial effusion or pleural effusion, or evidenced by B-type ultrasonic (\\>50ml).\n11. Cardiac surgery or cerebrovascular accident within recent six months.\n12. Preparing for heart transplantation or CRT, or has received CRT.\n13. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction more than 5 times/min, frequent paroxysmal ventricular tachycardia or triple rate).\n14. Serious hepatic or renal dysfunction (Cr\\>2.0mg/dl, AST or ALT 5 times above the normal upper limit).\n15. Serum potassium \\<3.2 mmol/L or \\>5.5 mmol/L.\n16. Systolic blood pressure \\<90mmHg or \\>160mmHg.\n17. Pregnant or plan to pregnant.\n18. Patients who participated in any clinical trial in the recent three months.\n19. Subject with a life expectancy less than 6 months as assessed by the investigator.\n20. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute.\n21. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).\n22. 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.\n23. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others)."}, 'identificationModule': {'nctId': 'NCT01541202', 'briefTitle': 'Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zensun Sci. & Tech. Co., Ltd.'}, 'officialTitle': 'A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure', 'orgStudyIdInfo': {'id': 'ZS-01-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo in addition to standard therapy', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'rhNRG-1', 'description': 'rhNRG-1 in addition to standard therapy', 'interventionNames': ['Drug: rhNRG-1']}], 'interventions': [{'name': 'rhNRG-1', 'type': 'DRUG', 'description': '10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks', 'armGroupLabels': ['rhNRG-1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Xuanwu hospital of Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cardiovascular Institute and Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "General Hospital of Chinese People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The Xinqiao Hospital of Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Provincial Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yet-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 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Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': "People's Hospital of Hunan Province", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital, Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Second Hospital affiliated to Suzhou University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated Hospital of Xuzhou Medical School', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "North Jiangsu People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'city': 'Zhenjiang', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliate Hospital of Jiangsu University', 'geoPoint': {'lat': 32.21086, 'lon': 119.45508}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The Second Hospital affiliated to Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Hospital affiliated to Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Jinzhou', 'state': 'Liaoning', 'country': 'China', 'facility': 'The first affiliated hospital of Liaoning medical college', 'geoPoint': {'lat': 41.10778, 'lon': 121.14167}}, {'city': 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'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital, Medical School of Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital, Medical School of Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "The first people's hospitial of Shanghai", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "The Sixth People's Hospital, Shanghai Jiaotong University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'The Second Hospital of Shanxi Medical College', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': "The second hospital of Xi'an jiaotong university", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Huaxi Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'Kunming General Hospital of Chengdu Military Region', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'The Second Hospital of Kunming Medical College', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Hospital affiliated to School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Runlin Gao, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Institute and Fuwai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zensun Sci. & Tech. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}