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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2200062039 |
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最近更新日期: Date of Last Refreshed on: |
2022-07-20 16:07:12 |
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注册时间: Date of Registration: |
2022-07-20 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
80岁及以上高血压患者强化与标准血压控制对心血管疾病转归的影响 |
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Public title: |
Effect of intensive versus standard blood pressure intervention on cardiovascular disease regression in the very elderly hypertensive patients |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
80岁及以上高血压患者强化血压对比标准降压的有效性及安全性的随机对照研究 |
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Scientific title: |
A randomized controlled study on the efficacy and safety of enhanced blood pressure comparison standard in hypertensive patients aged 80 years and over |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
曾敬 |
研究负责人: |
曾春雨 |
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Applicant: |
Zeng Jing |
Study leader: |
Zeng Chunyu |
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申请注册联系人电话: Applicant telephone: |
18696661682 |
研究负责人电话:
Study leader's |
13983624369 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
tduncan1130@163.com |
研究负责人电子邮件: Study leader's E-mail: |
chunyuzeng01@163.com |
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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): |
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申请注册联系人通讯地址: |
重庆市渝中区长江支路10号心内科 |
研究负责人通讯地址: |
重庆市渝中区长江支路10号心内科 |
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Applicant address: |
Department of Cardiology, No. 10, Changjiang Branch Road, Yuzhong District, Chongqing |
Study leader's address: |
Department of Cardiology, No. 10, Changjiang Branch Road, Yuzhong District, Chongqing |
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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: |
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申请人所在单位: |
中国人民解放军陆军特色医学中心 |
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Applicant's institution: |
Army Medical Center of PLA |
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研究负责人所在单位: |
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Affiliation of the Leader: |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
医研伦审(2022)第102号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
中国人民解放军陆军特色医学中心伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Army Medical Center of PLA |
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伦理委员会批准日期: Date of approved by ethic committee: |
2022-05-10 00:00:00 | ||
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伦理委员会联系人: |
王晶晶 |
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Contact Name of the ethic committee: |
Wang Jingjing |
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伦理委员会联系地址: |
重庆市渝中区长江支路10号大坪医院伦理办公室 |
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Contact Address of the ethic committee: |
Ethics office of Daping Hospital, No. 10 Changjiang Branch Road, Yuzhong District, Chongqing |
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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: |
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研究实施负责(组长)单位: |
陆军军医大学附属大坪医院 |
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Primary sponsor: |
Daping Hospital Affiliated to Army Medical University |
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研究实施负责(组长)单位地址: |
重庆市渝中区长江支路10号心内科 |
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Primary sponsor's address: |
Department of Cardiology, No. 10, Changjiang Branch Road, Yuzhong District, Chongqing |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
陆军军医大学优秀人才库重大扶持对象个性化培养方案 |
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Source(s) of funding: |
Individualized training program for major supporting objects of the excellent talent pool of the Army Medical University |
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研究疾病: |
高血压 |
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Target disease: |
Hypertension |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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研究目的: |
通过前瞻性、多中心、开放性随机对照试验,验证强化降压(110~130mmHg)对比标准降压(130~150mmHg)在老老年人群(≥80岁)高血压患者中是否存在更大获益以及明确其安全性。 |
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Objectives of Study: |
A prospective, double-blind, multicenter, randomized controlled trial was conducted to verify the differences in the effectiveness and safety of intensive blood pressure control (110-130 mmHg) versus standard (130-150 mmHg) in hypertensive patients in the very elderly hypertensive patients (≥80 years old). |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
1.年龄≥80岁(建议在有条件情况下尽量选择年龄偏大的受试者,85岁以上的受试者在总受试者人群中不应小于25%); |
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Inclusion criteria |
1.men or women aged ≥80 years at time of randomisation. There is no upper age limit. To ensure that the patients are aged ≥80 years their date of birth will need to be confirmed by an official national document. |
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排除标准: |
1.SBP≥200mmHg和或 DBP<60mmHg; |
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Exclusion criteria: |
1.SBP ≥ 200 mmHg, or DBP < 60 mmHg. |
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研究实施时间: Study execute time: |
从 From 2022-06-30 00:00:00至 To 2026-06-30 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2022-07-20 00:00:00 至 To 2023-06-30 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
中心系统随机产生分组编号 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Group number randomly generated by central system |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
公开/Public |
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盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
是Yes |
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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): |
原始数据在研究结果发表后在ResMan平台公开(http://www.medresman.org.cn/uc/index.aspx) |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
The original data will be published on the ResMan platform after the research results are published(http://www.medresman.org.cn/uc/index.aspx) |
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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: |
数据采集使用由中国人民解放军陆军特色医学中心伦理委员会审核通过的本研究专用病例记录表(CRF)。电子采集和管理系统使用ResMan临床试验公共管理平台(http://www.medresman.org.cn/uc/index.aspx)。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
The data were collected using the special case record form (CRF) approved by the ethics Committee of Army Medical Center of PLA. The electronic collection and management system uses ResMan clinical trial public management platform(http://www.medresman.org.cn/uc/index.aspx). |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |