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Application of TCM features comprehensive rehabilitation program in chronic heart failure treatment
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注册号:

Registration number:

ChiCTR1900026779 

最近更新日期:

Date of Last Refreshed on:

2019-10-21 

注册时间:

Date of Registration:

2019-10-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中医特色综合治疗方案在慢性心功能不全治疗中的应用研究 

Public title:

Application of TCM features comprehensive rehabilitation program in chronic heart failure treatment 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医特色综合治疗方案在慢性心功能不全治疗中的应用研究 

Scientific title:

Application of TCM features comprehensive rehabilitation program in chronic heart failure treatment 

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:

韩小婉 

研究负责人:

张明海 

Applicant:

Xiaowan Han 

Study leader:

Minghai Zhang 

申请注册联系人电话:

Applicant telephone:

+86 18810263577 

研究负责人电话:

Study leader's telephone:

+86 13701170968 

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:

965396781@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

Zhangmh0968@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:

北京市通州区翠屏西路116号 

研究负责人通讯地址:

北京市通州区翠屏西路116号 

Applicant address:

116 Cuiping Road West, Tongzhou District, Beijing 

Study leader's address:

116 Cuiping Road West, Tongzhou District, Beijing 

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:

北京中医药大学东直门医院,北京市通州区中医医院 

Applicant's institution:

Beijing University of Traditional Chinese Medicine Dongzhimen Hospital, Beijing Tongzhou District Chinese Medicine Hospital 

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:

DZMEC-KY-2019-140 

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:

北京中医药大学东直门医院伦理委员会 

Name of the ethic committee:

Dongzhimen Hospital Ethics Committee, Beijing University of Traditional Chinese Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-09 

伦理委员会联系人:

商建伟 

Contact Name of the ethic committee:

Jianwei Shang 

伦理委员会联系地址:

北京市东城区海运仓5号东直门医院伦理办公室 

Contact Address of the ethic committee:

Dongzhimen Hospital Ethics Office, 5 Haiyuncang, Dongcheng District, Beijing. 

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:

北京中医药大学东直门医院,北京市通州区中医医院 

Primary sponsor:

Beijing University of Traditional Chinese Medicine Dongzhimen Hospital, Beijing Tongzhou District Chinese Medicine Hospital 

研究实施负责(组长)单位地址:

北京市通州区翠屏西路116号 

Primary sponsor's address:

116 Cuiping Road West, Tongzhou District, Beijing 

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):

北京中医药大学东直门医院

具体地址:

东城区海运仓5号

Institution
hospital:

Beijing University of Traditional Chinese Medicine Dongzhimen Hospital

Address:

116 Cuiping Road West, Tongzhou District

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市通州区中医医院

具体地址:

通州区翠屏西路116

Institution
hospital:

Beijing Tongzhou District Chinese Medicine Hospital

Address:

116 Cuiping Road West, Tongzhou District

经费或物资来源:

北京市通州区科学技术委员会 

Source(s) of funding:

Beijing Tongzhou District Science and Technology Committee 

研究疾病:

慢性心功能不全 

Target disease:

Chronic 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:

探索性研究/预试验 

Study phase:

研究目的:

评价中医特色综合治疗方案在慢性心功能不全患者治疗中的应用价值。 

Objectives of Study:

To evaluate the value of comprehensive treatment of traditional Chinese medicine in patients with 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:

随机平行对照 

Study design:

Parallel 

纳入标准:

1) 年龄在40-75岁之间者; 2) 符合慢性心力衰竭慢性稳定期诊断标准; 3) 心功能NYHA分级为I、II级; 4) 射血分数保留型及中间型(LVEF≥40%)患者; 5) 符合2007年美国《心脏康复和二级预防指南》中WHO定义心脏康复患者; 6) 签署知情同意书者。 

Inclusion criteria

1) Age between 40-75 years; 2) Comply with chronic heart failure, chronic stable phase diagnostic criteria; 3) Heart function NYHA grade is I, II; 4) patients with ejection fraction retention and intermediate type (LVEF >= 40%); 5) Meet the WHO definition of cardiac rehabilitation patients in the 2007 US Guidelines for Cardiac Rehabilitation and Secondary Prevention; 6) Sign the informed consent form. 

排除标准:

1) 慢性心衰病情严重或者其他原因限制活动者; 2) 处于慢性心力衰竭的急性发作期; 3) 高血压控制不良者(收缩压≥180mmHg,或舒张压≥1OOmmHg); 4) 静息状态心率超过120次/分,或合并恶性心律失常(阵发性室速)近期反复发作者; 5) 合并严重的肾功能不全、肝功能不全者; 6) 合并严重慢阻肺、肺心病或呼吸衰竭患者; 7) 合并严重造血系统、肿瘤等严重原发性疾病; 8) 合并精神病、重度神经官能症者; 9) 妊娠哺乳期妇女。 

Exclusion criteria:

1) Chronic heart failure is severe or restricts activities for other reasons; 2) In the acute phase of chronic heart failure; 3) Those with poor hypertension control (systolic blood pressure >=180mmHg, or diastolic blood pressure >=1OOmmHg); 4) Resting state heart rate more than 120 beats / min, or combined with malignant arrhythmia (paroxysonic ventricular tachycardia) recently repeated authors; 5) Patients with severe renal insufficiency and liver dysfunction; 6) Patients with severe chronic obstructive pulmonary disease, pulmonary heart disease or respiratory failure; 7) Combine serious hematopoietic system, tumor and other serious primary diseases; 8) Patients with mental illness and severe neurosis; 9) Pregnant and lactating women. 

研究实施时间:

Study execute time:

From2019-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

干预组

样本量:

60

Group:

Intervention group

Sample size:

干预措施:

穴位推拿+运动训练

干预措施代码:

Intervention:

Acupoint massage+sport training

Intervention code:

组别:

对照组

样本量:

60

Group:

Control group

Sample size:

干预措施:

运动训练

干预措施代码:

Intervention:

sport training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学东直门医院 

单位级别:

三甲 

Institution
hospital:

Dongzhimen Hospital, Beijing University of Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

6分钟步行试验

指标类型:

主要指标 

Outcome:

6 minute walk test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动心肺试验

指标类型:

主要指标 

Outcome:

Exercise cardiopulmonary test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超声心动指标

指标类型:

次要指标 

Outcome:

Echocardiographic index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NT-pro BNP

指标类型:

次要指标 

Outcome:

NT-pro BNP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SF-36

指标类型:

次要指标 

Outcome:

SF-36

Type:

Secondary 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:

外周血

组织:

Sample Name:

Peripheral blood

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:

尿

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

利用SPSS20.0软件由计算机软件产生随机序列。

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

The random sequence will generated by using SPSS.

盲法:

open label

Blinding:

open label

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

结题会

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

At the project conclusion discussion meeting

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-21
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