ChiCTR-ONC-12002085 版本V1.3 版本创建时间2017/10/8 11:08:17 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR-ONC-12002085 

最近更新时间:

Date of Last Refreshed on:

2017/10/8 11:04:48 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

首次在人体经皮肺动脉去神经术治疗肺动脉高压的研究:PADN-1 研究 

Public title:

First-in-Man of Pulmonary artery denervation for treatment of pulmonary artery hypertention: the PADN-1 trial 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

首次在人体经皮肺动脉去神经术治疗肺动脉高压的研究:PADN-1 研究 

Scientific title:

First-in-Man of Pulmonary artery denervation for treatment of pulmonary artery hypertention: the PADN-1 trial 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

JPOMP-2012001, NMHB-2012100 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

陈绍良 

研究负责人:

陈绍良 

Applicant:

Shao-Liang Chen 

Study leader:

Shao-Liang Chen 

申请注册联系人电话:

Applicant telephone:

+86 13605157029 

研究负责人电话:

Study leader's telephone:

+86 13605157029 

申请注册联系人传真 :

Applicant Fax:

+86 25 52208048 

研究负责人传真:

Study leader's fax:

+86 25 52208048 

申请注册联系人电子邮件:

Applicant E-mail:

chmengx@126.com 

研究负责人电子邮件:

Study leader's E-mail:

chmengx@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:

中国,南京市长乐路68号 

研究负责人通讯地址:

中国,南京市长乐路68号 

Applicant address:

68 Changle Road, Nanjing, China 

Study leader's address:

68 Changle Road, Nanjing, China 

申请注册联系人邮政编码:

Applicant postcode:

210006 

研究负责人邮政编码:

Study leader's postcode:

210006 

申请人所在单位:

南京市第一医院,南京医科大学 

Applicant's institution:

Nanjing First Hospital, Nanjing Medical 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:

KY20120427-02 

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:

南京市第一医院伦理委员会 

Name of the ethic committee:

Ethic Committe of Nanjing First Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-04-01 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

江苏省卫生厅 

Primary sponsor:

Jiangsu Provincial Outstanding Medical Program 

研究实施负责(组长)单位地址:

中国,南京,中央路 

Primary sponsor's address:

Zhongyang Road, Nanjing, 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

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京市第一医院

具体地址:

中国,南京市长乐路68号

Institution
hospital:

Nanjing First Hospital

Address:

68 Changle Road, Nanjing, China

经费或物资来源:

江苏省优秀科技项目 

Source(s) of funding:

JPOMP-2012001, NMHB-2012100 

研究疾病:

肺动脉高压 

Target disease:

Pulmonary artery hypertension 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

比较经皮肺动脉去神经术治疗肺动脉高压的安全性和有效性 

Objectives of Study:

To compare the safety and efficacy of pulmonary artery denervation (PADN) for treament of pulmonary artery hypertension 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1,年龄<70岁; 2,原发性肺动脉高压; 3,继发于结缔组织疾病的肺动脉高压; 4,继发于慢性肺动脉栓塞(≥3个月)的肺动脉高压; 5,继发于肺纤维化的肺动脉高压; 6,继发于肝硬化的肺动脉高压; 7,外科心脏手术后的肺动脉高压; 8,平均肺动脉压≥25 mmHg(静息时)或≥30 mmHg(运动时); 9,自愿接受方案要求的所有随访评估。 

Inclusion criteria

1. Age<70 yr; 2. Primary pulmonary artery hypertension; 3. pulmonary artery hypertension secondary from connective-tissue diseases; 4. pulmonary artery hypertension from chronic(>=3-month) pulmonary thrombus; 5. pulmonary artery hypertension secondary from Pulmonary fibrosis; 6. pulmonary artery hypertension secondary from cirrhosis; 7. Pulmonary hypertension after surgical cardiac surgery; 8. Mean pulmonary artery pressure>=25 mmHg(Resting), or >=30 mmHg (Exercise); 9. Voluntary acceptance of all follow-up assessment of program requirements. 

排除标准:

1. 年龄≥70岁; 2. 继发于房间隔缺损,或室间隔缺损,或动脉导管未闭的肺动脉高压; 3. 肾功能不全; 4. 肝功能不全; 5. 血小板计数<100,000/L; 6. 心外膜冠状动脉狭窄≥70%; 7. 既往接受过经皮冠状动脉腔内成形术或冠状动脉搭桥术治疗的患者; 8. 有家族型不明原因晕厥史者; 9. 预期寿命<12个月; 10. 孕妇; 11. 系统性炎症; 12. 恶性肿瘤患者; 13. 三尖瓣; 14. 肺动脉瓣重度狭窄; 15. 诊断为深静脉血栓<3个月; 16. 对研究中所使用的药物过敏; 17. 对金属材料过敏; 18. 甲状腺功能不全; 19. 下腔静脉异常; 20. 急性血管扩张试验阳性 

Exclusion criteria:

1. pulmonary artery hypertension secondary from atrial septal defect, or from ventricular septal defect, or from patent duct artery; 2. Renal dysfunction; 3. Liver dysfunction; 4. Blood platelet count<100,000/L; 5. Diameter stenosis of any epicardial coronary artery>=70%; 6. history of percutaneous coronary intervention or coronary artery bypass graft; 7. Family history of syncope of unknown reasons; 8. Expected life span<12-month; 9. In pregnance; 10. Systematical inflammation; 11. Malignant cancer(s); 12. Tricuspid or pulmonary valve stenosis; 13. Supra-pulmonary valve stenosis; 14. Dianosed deep venous thrombus<3-month; 15. Allergic to studied drugs; 16. Allergic to metal materials; 17. Normal thyroid function; 18. inferior vena cava normal; 19. positive result from adenosine test (defined as a decrease of the mean PAP "10 mm Hg to an absolute level of <40 mm Hg, measured by right heart atheterization). 

研究实施时间:

Study execute time:

From2012-04-10To 2014-04-10 

干预措施:

Interventions:

组别:

1

样本量:

30

Group:

one

Sample size:

干预措施:

肺动脉成形

干预措施代码:

Intervention:

pulmonary artery renervation(PADN)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京市第一医院 

单位级别:

三甲 

Institution
hospital:

Nanjing First Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京市心脏中心 

单位级别:

三甲 

Institution
hospital:

Nanjing Heart Center  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

宜兴 

Country:

China 

Province:

Jiangsu 

City:

Yixin 

单位(医院):

宜兴市人民医院 

单位级别:

三甲 

Institution
hospital:

Yixin People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

溧阳 

Country:

China 

Province:

Jiangsu 

City:

Liyang 

单位(医院):

溧阳市人民医院 

单位级别:

三甲 

Institution
hospital:

LiYang People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

溧阳 

Country:

China 

Province:

Jiangsu 

City:

LiYang 

单位(医院):

溧阳市中医院 

单位级别:

三甲 

Institution
hospital:

Liyang Traditional Chinese Medcine Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

张家港 

Country:

China 

Province:

Jiangsu 

City:

Zhangjiagang 

单位(医院):

张家港市人民医院 

单位级别:

三甲 

Institution
hospital:

Zhangjiagang People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

常熟 

Country:

China 

Province:

Jiangsu 

City:

Changshu 

单位(医院):

常熟市人民医院 

单位级别:

三甲 

Institution
hospital:

Changshu People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏省 

市(区县):

金坛 

Country:

China 

Province:

Jiangsu 

City:

Jintan 

单位(医院):

金坛市人民医院 

单位级别:

三甲 

Institution
hospital:

Jintan People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

太仓 

Country:

China 

Province:

Jiangsu 

City:

Taicang 

单位(医院):

太仓市人民医院 

单位级别:

三甲 

Institution
hospital:

Tanicang People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

常州 

Country:

China 

Province:

Jiangsu 

City:

Changzhou 

单位(医院):

常州市中医院 

单位级别:

三甲 

Institution
hospital:

Changzhou Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

沭阳 

Country:

China 

Province:

Jiangsu 

City:

Shuyang 

单位(医院):

沭阳市中医院 

单位级别:

三甲 

Institution
hospital:

Shuyang Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

淮南 

Country:

China 

Province:

Anhui 

City:

Huainan 

单位(医院):

淮南东方医院集团总院 

单位级别:

三甲 

Institution
hospital:

Huainan Oriental General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

淮南 

Country:

China 

Province:

Anhui 

City:

Huainan 

单位(医院):

淮南市人民医院 

单位级别:

三甲 

Institution
hospital:

Huainan People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

淮南 

Country:

China 

Province:

Anhui 

City:

Huainan 

单位(医院):

淮南市新华医疗集团新华医院 

单位级别:

三甲 

Institution
hospital:

Huainan Xinhua Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

宣城 

Country:

China 

Province:

Anhui 

City:

Xuancheng 

单位(医院):

宣城市人民医院 

单位级别:

三甲 

Institution
hospital:

Xuancheng People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

界首 

Country:

China 

Province:

Anhui 

City:

Jieshou 

单位(医院):

界首市人民医院 

单位级别:

三甲 

Institution
hospital:

Jieshou People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

马鞍山 

Country:

China 

Province:

Anhui 

City:

Maanshan 

单位(医院):

马鞍山市中心医院 

单位级别:

三甲 

Institution
hospital:

Maanshan Central 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):

上海市第十人民医院 

单位级别:

三甲 

Institution
hospital:

Shanghai 10th People's Hospital  

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):

北京市阜外医院 

单位级别:

三甲 

Institution
hospital:

Beijing Fuwai Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

Fujian 

City:

Fuzhou 

单位(医院):

福建医科大学附属医院 

单位级别:

三甲 

Institution
hospital:

Fujian Medical University Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

6分钟步行距离

指标类型:

主要指标 

Outcome:

6-min.walking distance

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型利钠肽

指标类型:

附加指标 

Outcome:

N-terminal BNP

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺动脉阻力

指标类型:

附加指标 

Outcome:

Pulmonary artery resistance

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺动脉穿孔

指标类型:

副作用指标 

Outcome:

Pulmonary artery perforation

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺动脉血栓

指标类型:

副作用指标 

Outcome:

Pulmonary artery thrombus

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

右室功能

指标类型:

附加指标 

Outcome:

Right ventricular function

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺动脉直径

指标类型:

附加指标 

Outcome:

Pulmonary artery diameter

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

平均肺动脉压

指标类型:

主要指标 

Outcome:

Mean pulmonary artery pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Tei index

指标类型:

主要指标 

Outcome:

Tei index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺动脉收缩压

指标类型:

次要指标 

Outcome:

Systolic pulmonary artery pressure

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:

血液

组织:

Sample Name:

Blood

Tissue:

No

人体标本去向

使用后销毁 

说明

采集时间点:术前,术中,术后1周,术后3个月,6个月。

Fate of sample:

Destruction after use 

Note:

Before, during, 1-week,3-month and 6-month after interventional procedure

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 5 years
最大 Max age 70 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):

本研究非随机研究

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

This study will not be a randomized study

UTN(全球唯一识别码):

盲法:

Blinding:

No

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

Not be calculated

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

0

Data collection Institution:

资料管理单位:

Nanjing Shangke Scientific Advisory Lt.Co.

Data management Institution:

Nanjing Shangke Scientific Advisory Lt.Co.

资料分析单位:

Nanjing Medical University

Data analysis Institution:

Nanjing Medical University

注册人:

Name on Registration:

 2012-04-04