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卡维地洛与普萘洛尔降低肝硬化门脉高压患者HVPG的随机对照试验
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注册号:

Registration number:

ChiCTR-IPR-17012836 

最近更新日期:

Date of Last Refreshed on:

2017-09-29 

注册时间:

Date of Registration:

2017-09-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

卡维地洛与普萘洛尔降低肝硬化门脉高压患者HVPG的随机对照试验 

Public title:

Randomized controlled trial of carvedilol and propranolol in the treatment of HVPG patients with cirrhosis and portal hypertension 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

卡维地洛与普萘洛尔降低肝硬化门脉高压患者HVPG的随机对照试验 

Scientific title:

Randomized controlled trial of carvedilol and propranolol in the treatment of HVPG patients with cirrhosis and portal hypertension 

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:

陈敏 

研究负责人:

诸葛宇征 

Applicant:

Min Chen 

Study leader:

Yuzheng Zhuge 

申请注册联系人电话:

Applicant telephone:

+86 15205157078 

研究负责人电话:

Study leader's telephone:

+86 15996289206 

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:

1609484320@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

yuzheng9111963@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:

江苏省南京市中山路321号 

研究负责人通讯地址:

江苏省南京市中山路321号 

Applicant address:

321 Zhongshan Road, Nanjing, Jiangsu, China 

Study leader's address:

321 Zhongshan Road, Nanjing, 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:

南京大学医学院附属鼓楼医院 

Applicant's institution:

Drum Tower Hospital affiliated to Nanjing University Medicine School 

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:

2017-039-02 

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:

南京大学医学院附属鼓楼医院医学伦理委员会 

Name of the ethic committee:

Drum tower hospital affiliated to nanjing university medicine school,medicine ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-04-25 

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:

南京大学医学院附属鼓楼医院 

Primary sponsor:

Drum Tower Hospital affiliated to Nanjing University Medicine School 

研究实施负责(组长)单位地址:

江苏省南京市中山路321号 

Primary sponsor's address:

321 Zhongshan Road, Nanjing, 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):

南京市

Country:

China

Province:

Jiangsu

City:

Nanjing city

单位(医院):

南京大学医学院附属鼓楼医院

具体地址:

江苏省南京市中山路321号

Institution
hospital:

Drum Tower Hospital affiliated to Nanjing University Medicine School

Address:

321 Zhongshan Road, Nanjing, Jiangsu, China

经费或物资来源:

自费 

Source(s) of funding:

Self financing 

研究疾病:

肝硬化门脉高压症 

Target disease:

portal hypertension and cirrhosis 

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:

我们的目的是比较卡维地洛与普萘洛尔降低肝硬化门静脉高压患者HVPG的效果及观察不良反应 

Objectives of Study:

Our aim was to compare the efficacy of carvedilol and propranolol in reducing HVPG in cirrhotic patients with portal hypertension and to observe adverse effects 

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18-75岁;2)组织活检或至少两种影像学检查确诊为肝硬化;3)胃镜证实中重度食管胃静脉曲张;4)重度食管胃静脉曲张未发生过出血(一级预防)、既往有食管静脉曲张出血史或急性出血5天后(二级预防);5)签署知情同意书者。 

Inclusion criteria

1. Aged 18-75 years old; 2. Tissue biopsy, or at least two imaging examinations, confirmed cirrhosis; 3. Endoscopic confirmation of moderate and severe esophageal and gastric varices; 4. ASevere gastroesophageal varices without bleeding(primary prevention)history of bleeding from esophageal varices or 5 days after acute bleeding (secondary prevention); 5. Signed informed consent. 

排除标准:

1)HVPG<12mmHg;2) 肝功能CTP分级为C级或重度腹水或严重肝衰竭者;3) 有非选择性β受体阻滞剂使用禁忌症,如支气管哮喘、心源性休克、心脏传导阻滞(Ⅱ-Ⅲ度房室传导阻滞)、重度或急性心力衰竭和窦性心动过缓以及对本品过敏等;4)同时服用影响非选择性β受体阻滞剂在体内代谢、吸收的药物;5)同时使用其他降低门脉压力的药物;6)合并肝癌或肝外肿瘤、门静脉癌栓或血栓;7)严重的心、肺、肝、肾功能不全,或严重出血性疾病或局部/全身感染,甲状腺功能低下、雷诺综合症、周围血管疾病等;8) 计划怀孕或已怀孕或哺乳的妇女; 

Exclusion criteria:

1. Basal HVPG less than 12 mmHg; 2. The hepatic function of CTP is graded as grade C or severe ascites or severe hepatic failure; 3. Contraindications to β-blockers, such as bronchial asthma, cardiogenic shock, heart block (II - III degree atrioventricular block), severe or acute heart failure and sinus bradycardia and allergic to this product etc; 4. Patients who takes drugs that affect the metabolism and absorption of non selective beta blockers in vivo; 5. Patients using other drugs that reduce portal pressure; 6. Patients with hepatocellular carcinoma or extrahepatic tumor, portal vein tumor thrombus, or thrombus; 7. Patients with severe heart, lung, liver, and kidney dysfunction, or severe hemorrhagic disease or local / systemic infection, hypothyroidism, Raynaud's syndrome, peripheral vascular disease, etc.; 8. Women who plans to become pregnant or pregnant or nursing. 

研究实施时间:

Study execute time:

From2017-10-10To 2019-01-10 

征募观察对象时间:

Recruiting time:

From2017-10-10To 2019-01-10 

干预措施:

Interventions:

组别:

第1组

样本量:

85

Group:

Group 1

Sample size:

干预措施:

卡维地洛10mg

干预措施代码:

Intervention:

carvedilol 10mg bid

Intervention code:

组别:

第2组

样本量:

85

Group:

Group 2

Sample size:

干预措施:

普萘洛尔60mg

干预措施代码:

Intervention:

propranolol 60mg bid

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):

南京市 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京大学医学院附属鼓楼医院 

单位级别:

三级甲等医院 

Institution
hospital:

Drum Tower Hospital affiliated to Nanjing University Medicine School  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

肝静脉压力梯度

指标类型:

主要指标 

Outcome:

hepatic venous pressure gradient

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:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

本试验采用完全随机法,电脑产生随机数字表,随机分配受检者进入试验组或对照组。

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

Completely random method is applied in this experiment, computer generated random number table, patients randomly assigned into the experimental group or control group.

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):

实验完成后6个月,在中国临床实验数据管理公共平台上公布。

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

Six months after the trial is completed, the data will share at ResMan (clinical trial data management public platform in China).

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:

数据保存在中国临床试验数据管理公共平台,专家指导自行管理,包括原始数据,病例报告表,用excel数据库。

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

ResMan (clinical trial data management public platform in China),under expert guidance to manage data, including raw data, case report form, using excel database.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2017-09-29
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