今天是:2022-01-25 星期二

肝细胞生长因子与慢性心力衰竭的相关性研究
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注册号:

Registration number:

ChiCTR2100053825 

最近更新日期:

Date of Last Refreshed on:

2022-01-19 

注册时间:

Date of Registration:

2021-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肝细胞生长因子与慢性心力衰竭的相关性研究 

Public title:

study on the correlation between hepatocyte growth factor and chronic heart failure 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肝细胞生长因子与慢性心力衰竭的相关性研究 

Scientific title:

Correlation between plasma hepatocyte growth factor concentration and chronic heart failure 

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:

冯静 

研究负责人:

胡泽平 

Applicant:

Jing Feng 

Study leader:

Zeping Hu 

申请注册联系人电话:

Applicant telephone:

18919711682 

研究负责人电话:

Study leader's telephone:

13955174705 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

374974337@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1431318679@qq.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:

安徽医科大学第一附属医院 

研究负责人通讯地址:

安徽医科大学第一附属医院 

Applicant address:

First affiliated hospital of Anhui medical university 

Study leader's address:

First affiliated hospital of Anhui medical university 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

安徽医科大学第一附属医院 

Applicant's institution:

First affiliated hospital of Anhui medical university 

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:

PJ2021-15-10 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

安徽医科大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Anhui Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-11-24 

伦理委员会联系人:

周涛 

Contact Name of the ethic committee:

Tao Zhou 

伦理委员会联系地址:

安徽医科大学第一附属医院 

Contact Address of the ethic committee:

First affiliated hospital of Anhui medical university 

伦理委员会联系人电话:

Contact phone of the ethic committee:

62923537 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

331417268@qq.com 

研究实施负责(组长)单位:

安徽医科大学第一附属医院 

Primary sponsor:

First affiliated hospital of Anhui medical university 

研究实施负责(组长)单位地址:

安徽省合肥市蜀山区高新技术开发区皖水路120号 

Primary sponsor's address:

No.120 Wanshui Road, High-tech Development Zone, Shushan District, Hefei , Anhui 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

安徽省

市(区县):

Country:

China

Province:

Anhui

City:

单位(医院):

安徽医科大学第一附属医院

具体地址:

安徽省合肥市蜀山区高新技术开发区皖水路120号

Institution
hospital:

First affiliated hospital of Anhui medical university

Address:

No.120 Wanshui Road, High-tech Development Zone, Shushan District, Hefei , Anhui

经费或物资来源:

安徽省高校自然科学研究重大项目 

Source(s) of funding:

Major projects of natural science research in colleges and universities of Anhui Province 

研究疾病:

慢性心力衰竭 

Target disease:

Chronic heart failure 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

肝细胞生长因子可用于慢性心力衰竭的诊断。 

Objectives of Study:

Hepatocyte growth factor can be used in the diagnosis of chronic heart failure. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

(1)符合慢性心衰的诊断标准; (2)NYHA心功能分级为I-IV级; (3)年龄18岁至100岁; (4)同意参与本项研究并签署知情同意书; 

Inclusion criteria

(1) meet the diagnostic criteria of chronic heart failure; (2) NYHA cardiac function classification is grade I-IV; (3) Aged 18to 100 years; (4) agree to participate in the study and sign informed consent.  

排除标准:

(1)由于肝、肾等重要脏器功能衰竭导致的心力衰竭者; (2)妊娠期或哺乳期妇女、过敏体质及对多种药物过敏者; (3)合并有肝、肾及内分泌系统、造血系统等严重原发性疾病; (4)有精神异常及不愿合作者; (5)患者3个月内参加了其他临床试验 

Exclusion criteria:

(1) heart failure due to liver and kidney failure; (2) pregnant or lactating women, allergic constitution and allergic to multiple drugs; (3) combined with severe primary diseases such as liver, kidney and endocrine system, hematopoietic system, etc.; (4) mentally abnormal and unwilling to cooperate; (5) the patients took part in other clinical trials within 3 months.  

研究实施时间:

Study execute time:

From2021-11-01To 2023-06-30 

征募观察对象时间:

Recruiting time:

From2021-11-17To 2022-06-30 

干预措施:

Interventions:

组别:

心衰组

样本量:

1000

Group:

heart failure

Sample size:

干预措施:

干预措施代码:

Intervention:

empty

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽省 

市(区县):

合肥市 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽医科大学第一附属医院 

单位级别:

三甲 

Institution
hospital:

First affiliated hospital of Anhui medical university  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

肝细胞生长因子浓度

指标类型:

主要指标 

Outcome:

Hepatocyte growth factor concentration

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

B型钠尿肽

指标类型:

主要指标 

Outcome:

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:

心脏射血分数

指标类型:

主要指标 

Outcome:

EF

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生长刺激表达因子2

指标类型:

主要指标 

Outcome:

ST2

Type:

Primary indicator 

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:

静脉血浆

组织:

Sample Name:

Intravenous plasma

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 18 years
最大 Max age 100 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):

由研究员采用简单随机化分组方法产生随机序列

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

Random sequences are generated by researchers using a simple randomized grouping method

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

是Yes

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):

安徽医科大学第一附属医院

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

First affiliated hospital of Anhui medical university

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:

病例记录表

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

Case record form,CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-11-30
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