今天是:2022-08-12 星期五

注射用益气复脉(冻干)治疗冠心病心力衰竭急性加重期的多中心、随机、对照评价研究
下载XML文档

注册号:

Registration number:

ChiCTR-IPR-15007396 

最近更新日期:

Date of Last Refreshed on:

2015-11-15 

注册时间:

Date of Registration:

2015-11-04 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

注射用益气复脉(冻干)治疗冠心病心力衰竭急性加重期的多中心、随机、对照评价研究 

Public title:

Assessment of Complementary Treatment with Yiqi Fumai Lyophilized Injection on Acute Decompensated Ischemic Heart Failure: a Multicenter, Randomized, Controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

慢性心力衰竭病证结合干预的疗效研究 

Scientific title:

Study on the efficacy of interventions for chronic heart failure syndroms 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

唐娥 

研究负责人:

毛静远 

Applicant:

E Tang 

Study leader:

Jingyuan Mao 

申请注册联系人电话:

Applicant telephone:

+86 13820599175 

研究负责人电话:

Study leader's telephone:

+86 022-27432019 

申请注册联系人传真 :

Applicant Fax:

+86 022-27432019 

研究负责人传真:

Study leader's fax:

+86 022-27432019 

申请注册联系人电子邮件:

Applicant E-mail:

521tange@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jymao@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

天津市南开区鞍山西道314号 

研究负责人通讯地址:

天津市南开区鞍山西道314号 

Applicant address:

314 West Anshan Road, Nankai District, Tianjin, China 

Study leader's address:

314 West Anshan Road, Nankai District, Tianjin, China 

申请注册联系人邮政编码:

Applicant postcode:

300193 

研究负责人邮政编码:

Study leader's postcode:

300193 

申请人所在单位:

天津中医药大学第一附属医院 

Applicant's institution:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine  

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

TYLL2015[K]字004 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

天津中医药大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethic Committee of First Teaching Hospital of Tianjin University of Traditional Chinese medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2015-09-21 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

天津中医药大学第一附属医院 

Primary sponsor:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

天津市南开区鞍山西道314号 

Primary sponsor's address:

314 West Anshan Road, Nankai District, Tianjin, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

国家中医药管理局

具体地址:

北京市东城区工体西路1号

Institution
hospital:

State Administration of Traditional Chinese Medicine

Address:

1 West Gongti Road, Dongcheng District, Beijing, China

经费或物资来源:

“十二五”国家科技支撑计划 

Source(s) of funding:

"12.5" Project of China 

研究疾病:

冠心病心衰 

Target disease:

Ischemic heart failure  

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

在西药规范治疗的基础上加载注射用益气复脉(冻干):1.进一步降低冠心病心力衰竭急性加重期患者的血浆BNP水平2.降低冠心病心力衰竭急性加重期患者2个月病死率和再住院率 

Objectives of Study:

For further reduction of BNP levels and 2-month mortality and readmission rates in acute decompensated ischemic heart failure patients by complementary treatment with Yiqi Fumai Lyophilized Injection. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.年龄40-79岁;2.明确冠心病病史;3.符合慢性心力衰竭急性加重期诊断标准;4.NYHA心功能分级Ⅲ~Ⅳ级;5.BNP>200pg/ml;6.符合气阴两虚中医辨证标准;7.签署知情同意书。 

Inclusion criteria

1. Aged 40 to 79; 2. Patients with coronary heart disease; 3. Patients with acute decompensated chronic heart failure; 4. Cardiac function classification: New York Heart Association (NYHA) III to IV; 5. Those whose Brain Natriuretic Peptide(BNP)>200pg/mL; 6. Patients with Qi-yin deficiency syndrome; 7. Signed informed consent. 

排除标准:

1.首诊急性心力衰竭者;2.有下列疾病之一者:a.急性冠脉综合征;b.低血压(收缩压﹤90mmHg);c.心源性休克;d.药物难以控制的高血压(收缩压≥180mmHg和/或舒张压≥110mmHg);e.Ⅱ度Ⅱ型以上窦房或房室传导阻滞未置入起搏器治疗、难以控制的恶性心律失常;f.严重瓣膜疾病;g.扩张型心肌病;h.肥厚梗阻性心肌病;i.心肌炎;j.肺动脉栓塞;k.肺心病;l.近6个月内脑卒中者等;3.近2月内计划行血运重建术或CRT治疗的患者;4.肝功能谷丙转氨酶>3倍ULN(正常值上限)者;5.血清肌酐>2倍ULN(正常值上限)者;6.甲亢等严重内分泌疾病者;7.血红蛋白≤9g/dl者;8.精神病患者;9.恶性肿瘤患者;10.妊娠或计划妊娠者,哺乳期妇女;11.对研究药物可疑或明确过敏;12.近2月内参加其他研究者。 

Exclusion criteria:

1. Those who suffer from acute heart failure on initial diagnosis; 2. Those who have one of the following diseases: 1) Acute coronary syndrome; 2) Hypotension (systolic blood pressure<90mmHg); 3) Cardiogenic shock; 4) Uncontrolled high blood pressure (systolic blood pressure>=180mmHg and/or diastolic blood pressure>=110mmHg); 5) Degree II typeII or severe sinoatrial or atrioventricular block without pacemaker implantation, uncontrolled malignant arrhythmia; 6) Severe valve disease; 7) Dilated cardiomyopathy; 8) Hypertrophic obstructive cardiomyopathy; 9) Myocarditis; 10) Pulmonary embolism; 11) Pulmonary heart disease; 12) Stroke within 6 months; 3. Preparation for revascularization or cardiac resynchronization therapy (CRT) within 2 months; 4. Alanine aminotransferase(ALT)>3 times the upper limit of normal; 5. Serum creatinine>2 times the upper limit of normal; 6. Severe endocrine diseases such as hyperthyroidism, etc; 7. Hemoglobin(HB)<=9g/dl; 8. Mental disorder; 9. History of malignant tumor; 10. Being pregnant, planning for pregnancy or breastfeeding; 11. Suspicious or definite allergy to intervention drugs; 12. Participated in other trials within 2 months. 

研究实施时间:

Study execute time:

From2015-09-01To 2017-12-31 

征募观察对象时间:

Recruiting time:

From2015-09-01To 2017-02-28 

干预措施:

Interventions:

组别:

治疗组

样本量:

333

Group:

treatment group

Sample size:

干预措施:

西药规范治疗+注射用益气复脉(冻干)8瓶(0.65g/瓶)加入5%葡萄糖注射液或生理盐水250ml,60ml/h静脉滴注,每日1次

干预措施代码:

Intervention:

Standard Western treatment plus 5.2g Yiqi Fumai Lyophilized Injection in 5% GS or NS injection 250ml,60ml/h ivdrip,qd.

Intervention code:

组别:

对照组

样本量:

333

Group:

control group

Sample size:

干预措施:

西药规范治疗

干预措施代码:

Intervention:

Regular Western medication

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽中医学院第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Anhui University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

 

Country:

China 

Province:

Jilin 

City:

 

单位(医院):

长春中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital To Changchun University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

成都中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Teaching Hospital of Chengdu University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

甘肃 

市(区县):

 

Country:

China 

Province:

Gansu 

City:

 

单位(医院):

甘肃省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Gansu Provincial Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

甘肃 

市(区县):

 

Country:

China 

Province:

Gansu 

City:

 

单位(医院):

甘肃中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Gansu University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省中医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Provincial Hospital of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南中医学院第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Henan University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南省中医院 

单位级别:

三级甲等 

Institution
hospital:

Henan Provincial Hospital of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江西 

市(区县):

 

Country:

China 

Province:

Jiangxi 

City:

 

单位(医院):

江西中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

辽宁中医药大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京明基医院 

单位级别:

三级甲等 

Institution
hospital:

BenQ Medical Center  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

内蒙古 

市(区县):

 

Country:

China 

Province:

Neimenggu 

City:

 

单位(医院):

内蒙古自治区人民医院 

单位级别:

三级甲等 

Institution
hospital:

Inner Mongolia Autonomous Region People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

内蒙古 

市(区县):

 

Country:

China 

Province:

Neimenggu 

City:

 

单位(医院):

内蒙古医科大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Inner Mongolia Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

宁夏 

市(区县):

 

Country:

China 

Province:

Ningxia 

City:

 

单位(医院):

宁夏人民医院 

单位级别:

三级甲等 

Institution
hospital:

Ningxia People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西省中医院 

单位级别:

三级甲等 

Institution
hospital:

Traditional Chinese Medicine Hospital of Shanxi Province Level of the  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

陕西省中医医院 

单位级别:

三级甲等 

Institution
hospital:

Shanxi Provincial Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

陕西中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Shanxi University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

陕西中医学院第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital of Shanxi University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海龙华医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Longhua Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海曙光医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Shuguang Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海岳阳医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Yueyang Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海长征医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Changzheng Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海东方医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai East Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市中医药研究院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Academy of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津医科大学第二医院 

单位级别:

三级甲等 

Institution
hospital:

The 2nd Hospital of Tianjin Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市南开医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Nankai Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital of Tianjin University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

新疆 

市(区县):

 

Country:

China 

Province:

Xinjiang 

City:

 

单位(医院):

新疆维吾尔自治区中医医院 

单位级别:

三级甲等 

Institution
hospital:

Traditional Chinese Medical Hospital of Xinjiang Uyghur Autonomous Region  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

宁夏 

市(区县):

 

Country:

China 

Province:

Ningxia 

City:

 

单位(医院):

银川市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Yinchuan Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院西苑医院 

单位级别:

三级甲等 

Institution
hospital:

Xiyuan Hospital of China Academy of Chinese Medical Sciences  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

中国人民解放军第254医院 

单位级别:

三级甲等 

Institution
hospital:

Hospital of the PLA Second fifty-four  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

郑州市中医院 

单位级别:

三级甲等 

Institution
hospital:

Zhengzhou Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血浆脑钠肽

指标类型:

主要指标 

Outcome:

Brain natriuretic peptide (BNP)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

复合终点(全因死亡、心衰急诊/再住院、急性冠脉综合征、血运重建、恶性心律失常、心源性休克、脑卒中、肺栓塞)

指标类型:

次要指标 

Outcome:

Composite endpoint: including all-cause mortality, HF emergency/re -admission, acute coronary syndrome, revascularization, serious cardiac arrhythmias, cardiac shock, stroke, pulmonary embolism

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心脏超声(LVEF等)

指标类型:

次要指标 

Outcome:

Echocardiography(LVEF,etc)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血肌钙蛋白

指标类型:

次要指标 

Outcome:

Blood troponin (TNT/TNI)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心胸比

指标类型:

次要指标 

Outcome:

Cardiothoracic Ratio(CR)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存质量评分

指标类型:

次要指标 

Outcome:

Life quality scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医四诊信息计分

指标类型:

次要指标 

Outcome:

Scores from the four TCM diagnostic methods

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血尿常规

指标类型:

副作用指标 

Outcome:

blood and urine routine tests

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能

指标类型:

副作用指标 

Outcome:

liver and renal function tests

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血电解质

指标类型:

副作用指标 

Outcome:

serum electrolytes

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

副作用指标 

Outcome:

electrocardiogram (ECG)

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

副作用指标 

Outcome:

Adverse events

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

biood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

n尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 79 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

采用中央随机化管理系统(以下简称:IWRS)进行随机分组,将患者按1:1的比例随机分配到两组中的任一组别。当患者符合纳入/排除标准后,研究者通过网络登录到IWRS,按照系统提示输入相应纳排信息,生成患者身份识别码(SSID);根据身份识别码,对患者的心功能分级、年龄、性别等分层因素进行选择,随机系统为受试者分配唯一的随机编码及相应组别信息

Randomization Procedure (please state who generates the random number sequence and by what method):

Once the patient is included, the researcher will enter the Interactive Web Response System (IWRS) to randomization

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-11-04
返回列表