Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 6:48 PM
Study NCT ID:
NCT01612260
Status:
UNKNOWN
Last Update Posted:
2013-01-08
First Post:
2012-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shensong Yangxin Capsule in the Treatment of Heart Failure Complicated With Ventricular Premature Beat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D018879', 'term': 'Ventricular Premature Complexes'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 460}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-07', 'studyFirstSubmitDate': '2012-05-24', 'studyFirstSubmitQcDate': '2012-06-04', 'lastUpdatePostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'numbers of the Premature ventricular contractions during 24-hour ambulatory ECG', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'NYHA classification', 'timeFrame': '3 months'}, {'measure': 'LVEF', 'timeFrame': '3 months'}, {'measure': 'NT-proBNP', 'timeFrame': '3 months'}, {'measure': 'Minnesota living with heart failure questionnaire (MLHFQ)', 'timeFrame': '3 months'}, {'measure': '6 minute walking test', 'timeFrame': '3 months'}, {'measure': 'LVEDD', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['heart failure', 'ventricular premature complex', 'Shensong Yangxin capsule'], 'conditions': ['Heart Failure', 'Ventricular Premature Complex']}, 'referencesModule': {'references': [{'pmid': '28685712', 'type': 'DERIVED', 'citation': 'Wang X, Hu D, Dang S, Huang H, Huang CX, Yuan MJ, Tang YH, Zheng QS, Yin F, Zhang S, Zhang BL, Gao RL; Efficacy and Safety of Shensong Yangxin Capsules for Frequent VPCs in Congestive Heart Failure Study Group. Effects of Traditional Chinese Medicine Shensong Yangxin Capsules on Heart Rhythm and Function in Congestive Heart Failure Patients with Frequent Ventricular Premature Complexes: A Randomized, Double-blind, Multicenter Clinical Trial. Chin Med J (Engl). 2017 Jul 20;130(14):1639-1647. doi: 10.4103/0366-6999.209906.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of Chinese medicine Shensong Yangxin capsule for the chronic cardiac dysfunction complicated with ventricular premature beats.', 'detailedDescription': 'Premature ventricular contractions is one of the most common arrhythmia in the patients with structural heart disease and heart failure, which is not only has the high incidence but also has a high predictive value of sudden death. The purpose of the study is to assess the effects of Chinese medicine Shensong Yangxin capsule for the chronic cardiac dysfunction complicated with ventricular premature beats, which based on the numbers of premature ventricular contractions in 24-hour ambulatory electrocardiogram (ECG) as the main endpoint of the study. Secondary endpoints are evaluation of the Shensong Yangxin capsule on cardiac function and quality of life. This study is a randomized, double-blind, placebo controlled, multi-center trial. Chronic heart failure patients(cardiac function is Class II-III) associated with premature ventricular contractions (premature number 720-10000 / 24h), who received standardized treatment for heart failure at least three months, were involved in the study. Patients were randomly assigned into Shensong Yangxin capsule group or placebo group, with the capsule administration of 4 granules t.i.d.for 12 weeks. 24-hour ambulatory ECG, echocardiography and evaluation of heart function were observed at baseline and 12 weeks after the intervention. The primary outcomes are the numbers of premature ventricular contractions in 24-hour ambulatory ECG, and the secondary outcomes are New York Heart Association (NYHA) classification, NT-proBNP, left ventricular ejection fraction (LVEF) and left ventricular end-diastolic dimension (LVEDD, 6 minute walking test and Minnesota living with heart failure questionnaire (MLHFQ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cardiac function NYHA II\\~III, Left ventricular ejection fraction (LVEF) 35%\\~50% tested by Modified Simpson, has a stable hemodynamics and no need to deliver treatment through vein\n* To be treated by standard treatment of heart failure at least 3 months with a stable dosage already\n* Ventricular premature beats: 720-10000 beats/24 hours\n* Heart failure caused by ischemic heart disease, or dilated cardiomyopathy\n\nExclusion Criteria:\n\n* Subject to be expected to alive no more than 6 months\n* Subject suffered from acute coronary syndrome in last three months (Acute myocardial infarction of ST segment elevation and non ST segment elevation, unstable angina\n* To be complicated with persistent atrial fibrillation, atrioventricular conduction block (II degree of Type II or III degree), or acute myocarditis\n* To be complicated with ventricular fibrillation, torsion type ventricular heartbeat rate, sustained ventricular tachycardia, or non sustained ventricular tachycardia with rapid ventricular rate and hemodynamic disorders\n* Sinus heart rate less than 45 beats/minutes and needs to receive the pacemaker or has received pacemaker, or with abnormal sinus node function\n* The hypertension, diabetes difficult to be controlled'}, 'identificationModule': {'nctId': 'NCT01612260', 'briefTitle': 'Shensong Yangxin Capsule in the Treatment of Heart Failure Complicated With Ventricular Premature Beat', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan University'}, 'officialTitle': 'Shensong Yangxin Capsule in the Treatment of Mild to Moderate Systolic Heart Failure Complicated With Ventricular Premature Beat: A Randomize, Double Blind, Placebo-controlled Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': 'yl-yxb06-lcsyfa-201201'}, 'secondaryIdInfos': [{'id': '2012CB518600（2012CB518606）', 'type': 'OTHER_GRANT', 'domain': 'National Basic Research Program of China（973 Program）'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shensong Yangxin capsule', 'description': 'Shensong Yangxin capsule 4 granules t.i.d. po for 12weeks', 'interventionNames': ['Drug: Shensong Yangxin capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo Capsule', 'description': 'placebo Capsule 4 granules t.i.d. po for 12weeks', 'interventionNames': ['Drug: placebo Capsule']}], 'interventions': [{'name': 'Shensong Yangxin capsule', 'type': 'DRUG', 'description': 'ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks', 'armGroupLabels': ['Shensong Yangxin capsule']}, {'name': 'placebo Capsule', 'type': 'DRUG', 'description': '4 granules t.i.d. po for 12 weeks', 'armGroupLabels': ['placebo Capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'changsheng Ma, PH D', 'role': 'CONTACT', 'phone': '13901357404'}], 'facility': 'Beijing Anzhen Hospital, Capital University of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yong Wang, PH D', 'role': 'CONTACT', 'phone': '13801239117'}], 'facility': 'China-Japan Freindship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '404100', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xia Mei, PH D', 'role': 'CONTACT', 'phone': '13508322668'}], 'facility': 'Chongqing Zhongshan Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '530000', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'weifeng Wu, PH D', 'role': 'CONTACT', 'email': 'wucna@yahoo.com.cn', 'phone': '13907719960'}], 'facility': 'First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yue Xia, PH D', 'role': 'CONTACT'}], 'facility': 'The first hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'chunguang Qiu, PH D', 'role': 'CONTACT', 'phone': '13803898806'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '445000', 'city': 'Enshi', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yuanhong Li, PH D', 'role': 'CONTACT', 'phone': '13986843863'}], 'facility': 'Enshi Autonomous Region Central Hospital', 'geoPoint': {'lat': 30.3, 'lon': 109.48333}}, {'zip': '434000', 'city': 'Jingzhou', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xin Li, PH D', 'role': 'CONTACT', 'phone': '13872347567'}], 'facility': 'Jingzhou Central Hospital', 'geoPoint': {'lat': 30.35028, 'lon': 112.19028}}, {'zip': '442000', 'city': 'Shiyan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'handong Yang, PH D', 'role': 'CONTACT', 'phone': '13807285189'}], 'facility': 'General Hospital of Dongfeng Motor Corporation', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yangyang Dai, PH D', 'role': 'CONTACT', 'phone': '15327411241'}], 'facility': 'Wuhan Asia Heart Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '441000', 'city': 'Xiangyang', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wenwei Liu, PH D', 'role': 'CONTACT', 'phone': '13907279669'}], 'facility': 'Xiangyang Central Hospital', 'geoPoint': {'lat': 32.0422, 'lon': 112.14479}}, {'zip': '443000', 'city': 'Yichang', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jun Yang, PH D', 'role': 'CONTACT', 'phone': '13972561866'}], 'facility': 'The First College of Clinical Medical Science, China Three Gorges University', 'geoPoint': {'lat': 30.71444, 'lon': 111.28472}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jiangang Zou, PH D', 'role': 'CONTACT', 'email': 'jgzou@njmu.edu.cn', 'phone': '13605191407'}], 'facility': 'First hospital Affiliated to Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wei Xu, PH D', 'role': 'CONTACT', 'email': 'xuwei2003@medmail.com.cn', 'phone': '13390900868'}], 'facility': 'Nanjing Drum Tower Hospital,The Affiliated hospital of Nanjing University Medical school', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zulu Wang, PH D', 'role': 'CONTACT', 'email': 'wangzl@medmail.com.cn', 'phone': '13309824590'}], 'facility': 'The General Hospital of Shenyang Military Region', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'tian Wang, PH D', 'role': 'CONTACT'}], 'facility': 'Traffic hospitals of Shandong Province', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'liqun Wu, PH D', 'role': 'CONTACT', 'email': 'wuliquan89@hotmail.com', 'phone': '13801621534'}], 'facility': 'Ruijin Hospital, Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'fang Wang, PH D', 'role': 'CONTACT', 'email': 'onlyfang2@gmail.com', 'phone': '13621950918'}], 'facility': "Shanghai First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yunzeng Zou, PH D', 'role': 'CONTACT', 'phone': '13817702933'}], 'facility': 'Zhongshan Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'dejia Huang, PH D', 'role': 'CONTACT', 'phone': '13908181686'}], 'facility': 'Westchinahospital,Sichuanuniversity', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Cong-xin Huang, PH D', 'role': 'CONTACT', 'email': 'huangcongxin@yahoo.com.cn', 'phone': '13907131546'}, {'name': 'Xi Wang', 'role': 'CONTACT', 'email': 'xiwangwhu@16..com', 'phone': '15994207265'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cong-xin Huang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, {'name': 'Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Third Military Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Cong-xin Huang', 'investigatorAffiliation': 'Wuhan University'}}}}