Today is 2022-07-06

Effect of Beraprost Sodium on Pulmonary Arteria Hypertension with Left Ventricular Systolic Dysfunction
download

注册号:

Registration number:

ChiCTR-IPR-17012961 

最近更新日期:

Date of Last Refreshed on:

2017-10-12 

注册时间:

Date of Registration:

2017-10-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

贝前列素钠在左心收缩功能不全性肺动脉高压中的应用研究 

Public title:

Effect of Beraprost Sodium on Pulmonary Arteria Hypertension with Left Ventricular Systolic Dysfunction 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

贝前列素钠在左心收缩功能不全性肺动脉高压中的应用研究 

Scientific title:

Effect of Beraprost Sodium on Pulmonary Arteria Hypertension with Left Ventricular Systolic Dysfunction 

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:

赵良平 

研究负责人:

赵良平 

Applicant:

Zhao Liang-ping 

Study leader:

Zhao Liang-ping 

申请注册联系人电话:

Applicant telephone:

+86 15262456676 

研究负责人电话:

Study leader's telephone:

+86 15262456676 

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:

zhaoliangping1234@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

zhaoliangping1234@aliyun.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:

江苏省苏州市三香路1055号 

研究负责人通讯地址:

江苏省苏州市三香路1055号 

Applicant address:

1055 Sanxiang Road, Suzhou, Jiangsu, China 

Study leader's address:

1055 Sanxiang Road, Suzhou, Jiangsu, China 

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:

苏州大学附属第二医院 

Applicant's institution:

The Second Affiliated Hospital of Soochow 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:

000000 

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:

苏州大学附属第二医院伦理委员会 

Name of the ethic committee:

Ethics Committee of The Second Hospital Affiliated to Suzhou University  

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

苏州大学附属第二医院 

Primary sponsor:

The Second Affiliated Hospital of Soochow University 

研究实施负责(组长)单位地址:

江苏省苏州市三香路1055号 

Primary sponsor's address:

1055 Sanxiang Road, Suzhou, Jiangsu, 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):

江苏省

市(区县):

苏州市

Country:

China

Province:

Jiangsu

City:

Suzhou City

单位(医院):

苏州大学附属第二医院

具体地址:

江苏省苏州市三香路1055号

Institution
hospital:

The Second Affiliated Hospital of Soochow University

Address:

1055 Sanxiang Road, Suzhou, Jiangsu, China

经费或物资来源:

自筹 

Source(s) of funding:

Self financing 

研究疾病:

左心收缩功能不全性肺动脉高压 

Target disease:

Pulmonary Arteria Hypertension with Left Ventricular Systolic Dysfunction 

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:

本研究将左心收缩功能不全性肺动脉高压患者随机分为常规治疗组和贝前列素钠组,探讨在常规治疗的基础上加用贝前列素钠能否进一步降低患者的肺动脉压力、提高运动耐量、减少心脏事件发生率,并评估药物不良反应发生情况。 

Objectives of Study:

The study objective is to investigate the effect of beraprost sodium with routine treatment in reducing pulmonary artery pressure, improving exercise tolerance, reducing the incidence of cardiac events, and to assess the occurrence of adverse drug reactions.  

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18-80岁,男女不限;② 超声心动图测得肺动脉收缩压≥30mmhg,同时左室射血分数(EF)<45%;③ 自愿接受本研究。 

Inclusion criteria

1. Aged 18-80 years old, male or female; 2. pulmonary artery systolic pressure by echocardiography ≥ 30mmhg, and left ventricular ejection fraction <45%; 3. Willingness to accept this study. 

排除标准:

① 休克患者;② 其他类型的肺动脉高压(特发性、结缔组织病性、药物性、血栓栓塞性、慢性肺病性、门脉高压性、先天性心脏病性等);③ 严重肝功能不全;④ 出血性疾病;⑤ 妊娠、哺乳期女性;⑥ 依从性差,不按时用药和随访者。 

Exclusion criteria:

1. The shock patients; 2. The other type of pulmonary hypertension (idiopathic pulmonary hypertension; pulmonary hypertension by connective tissue diseases, drugs, thromboembolic, chronic lung disease, portal hypertension, congenital heart disease, etc.); 3. the severe hepatic insufficiency; 4. the hemorrhagic disease; 5. The pregnancy and lactation of the female; 6. Poor compliance, medication and follow-up were not on time. 

研究实施时间:

Study execute time:

From2017-10-01To 2020-09-30 

征募观察对象时间:

Recruiting time:

From2017-10-01To 2019-09-30 

干预措施:

Interventions:

组别:

贝前列素钠组

样本量:

150

Group:

Beraprost Sodium group

Sample size:

干预措施:

贝前列素钠

干预措施代码:

Intervention:

Beraprost Sodium

Intervention code:

组别:

常规治疗组

样本量:

150

Group:

Routine treatment group

Sample size:

干预措施:

常规药物

干预措施代码:

Intervention:

Routine medication

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

苏州市 

Country:

China 

Province:

Jiangsu 

City:

Suzhou City 

单位(医院):

苏州大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Soochow University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏省 

市(区县):

苏州市 

Country:

China 

Province:

Jiangsu 

City:

Suzhou City 

单位(医院):

苏州市吴江区第一人民医院 

单位级别:

三级 

Institution
hospital:

The first people's Hospital of Wujiang District, Suzhou  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏省 

市(区县):

苏州市 

Country:

China 

Province:

Jiangsu 

City:

Suzhou City 

单位(医院):

苏州市立医院北区 

单位级别:

三级 

Institution
hospital:

The north of suzhou city hospital  

Level of the institution:

Tertiary hospital 

测量指标:

Outcomes:

指标中文名:

肺动脉压力

指标类型:

主要指标 

Outcome:

pulmonary artery pressure

Type:

Primary indicator 

测量时间点:

3、6、9、12个月

测量方法:

超声心动图

Measure time point of outcome:

3, 6, 9, 12 months

Measure method:

Echocardiography

指标中文名:

左室射血分数

指标类型:

主要指标 

Outcome:

Left ventricular ejection fraction

Type:

Primary indicator 

测量时间点:

3、6、9、12个月

测量方法:

超声心动图

Measure time point of outcome:

3, 6, 9, 12 months

Measure method:

Echocardiography

指标中文名:

6分钟步行距离

指标类型:

主要指标 

Outcome:

6 minute walk distance

Type:

Primary indicator 

测量时间点:

3、6、9、12个月

测量方法:

6分钟步行试验

Measure time point of outcome:

3, 6, 9, 12 months

Measure method:

6 minute walk test

指标中文名:

主要不良心脏事件

指标类型:

主要指标 

Outcome:

Major adverse cardiac events

Type:

Primary indicator 

测量时间点:

12个月

测量方法:

随访

Measure time point of outcome:

12 month

Measure method:

follow-up

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

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 59 years
最大 Max age 72 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):

计算机随机数字法,研究管理员

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

Computer random number method from research administrator

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

2021-10-01,网络

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

2021-10-01, network

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:

病例记录表采集,数据管理员录入电脑,第三人核对数据

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

The case record collects the data, the data manager enters the computer, and the third checks the data

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2017-10-12
return list