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注册号: Registration number: |
ChiCTR2400084214 |
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最近更新日期: Date of Last Refreshed on: |
2024-05-13 08:56:56 |
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注册时间: Date of Registration: |
2024-05-13 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: |
参松养心胶囊在器质性心脏病合并室性心律失常患者中降低心脏性猝死复合事件的多中心、前瞻性、观察性、真实世界研究 |
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Public title: |
A multicenter, prospective, real-world study on the ShenSongYangXin Capsules in the reduction of composite events of sudden cardiac death in patients with organic heart disease and ventricular arrhythmia |
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注册题目简写: |
ACCEPT |
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English Acronym: |
ACCEPT |
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研究课题的正式科学名称: |
参松养心胶囊在器质性心脏病合并室性心律失常患者中降低心脏性猝死复合事件的多中心、前瞻性、观察性、真实世界研究 |
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Scientific title: |
A multicenter, prospective, real-world study on the ShenSongYangXin Capsules in the reduction of composite events of sudden cardiac death in patients with organic heart disease and ventricular arrhythmia |
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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: |
张玉玲 |
研究负责人: |
王景峰 |
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Applicant: |
Yuling Zhang |
Study leader: |
Jingfeng Wang |
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申请注册联系人电话: Applicant telephone: |
+86 137 1167 5897 |
研究负责人电话:
Study leader's |
+86 189 2891 6398 |
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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: |
zhyul@mail.sysu.edu.cn |
研究负责人电子邮件: Study leader's E-mail: |
wjingf@mail.sysu.edu.cn |
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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: |
广东省广州市沿江西路107号 |
研究负责人通讯地址: |
广东省广州市沿江西路107号 |
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Applicant address: |
107 West Yanjiang Road, Guangzhou, Guangdong, China |
Study leader's address: |
107 West Yanjiang Road, Guangzhou, Guangdong, China |
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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: |
中山大学孙逸仙纪念医院 |
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Applicant's institution: |
Sun Yat-sen Memorial Hospital, Sun Yat-sen University |
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研究负责人所在单位: |
中山大学孙逸仙纪念医院 |
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Affiliation of the Leader: |
Sun Yat-sen Memorial Hospital, Sun Yat-sen University |
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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: |
SYSKY-2023-902-01 |
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: |
中山大学孙逸仙纪念医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2023-08-30 00:00:00 | ||
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伦理委员会联系人: |
区柳珊 |
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Contact Name of the ethic committee: |
Liushan Ou |
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伦理委员会联系地址: |
广东省广州市沿江西路107号 |
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Contact Address of the ethic committee: |
107 West Yanjiang Road, Guangzhou, Guangdong, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 20 8133 2587 |
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: |
中山大学孙逸仙纪念医院 |
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Primary sponsor: |
Sun Yat-sen Memorial Hospital, Sun Yat-sen University |
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研究实施负责(组长)单位地址: |
广东省广州市沿江西路107号 |
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Primary sponsor's address: |
107 West Yanjiang Road, Guangzhou, Guangdong, China |
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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: |
石家庄以岭药业股份有限公司 |
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Source(s) of funding: |
Shijiazhuang Yiling Pharmaceutical Co., Ltd. |
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研究疾病: |
心脏性猝死 |
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Target disease: |
Sudden cardiac death |
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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: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
上市后药物 | ||||||||||||||||||||||
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Study phase: |
4 |
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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: |
本项目拟探究参松养心胶囊降低器质性心脏病合并心律失常患者心脏性猝死发生的疗效。通过统计患者中远期心脏性猝死综合事件(包括心脏性猝死、持续性室性心动过速或心室颤动、ICD放电事件及发生次数、以及可疑心脏性猝死)及其他心血管事件的发生率,以评估参松养心胶囊在预防心脏性猝死发生的临床效益。 |
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Objectives of Study: |
This project aims to explore the efficacy of ShenSongYangXin Capsules in reducing the occurrence of sudden cardiac death in patients with organic heart disease combined with arrhythmia. By statistically analyzing the incidence of long-term comprehensive sudden cardiac death events (including sudden cardiac death, persistent ventricular tachycardia or ventricular fibrillation, ICD discharge events and their frequency, and suspected sudden cardiac death) and other cardiovascular events in patients, we aim to evaluate the clinical benefits of ShenSongYangXin Capsules in preventing the occurrence of sudden cardiac death. |
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药物成份或治疗方案详述: |
研究组:原发器质性心脏病常规治疗+参松养心胶囊 对照组:原发器质性心脏病常规治疗 参松养心胶囊的使用剂量参照药品说明书(2-4粒,3次/日),由接诊医师依据各患者临床实际情况决定。 |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
(1) 有外科手术或内科介入手术指证的心脏瓣膜病患者 (2) 入组前30天内发生心肌梗死、卒中、不稳定心绞痛、短暂脑缺血发作或因急性心力衰竭住院治疗的患者 (3) 妊娠或正准备妊娠及哺乳期妇女 (4) 患者不能或不愿遵守研究方案并完成随访 (5) 有未控制的甲状腺功能亢进症和甲状腺功能减退症、严重感染、严重肝肾功能不全(ALT≥3倍,或/和任何公式计算的eGFR≤30mL/min)、恶性肿瘤等 (6) 急性或亚急性感染性心内膜炎 (7) 各种病因的重度肺动脉高压(重度肺动脉高压,指肺动脉收缩压>70mmHg) (8) 严重的电解质紊乱、酸碱失衡 (9) 患者对胶粘剂或水凝胶类产品有己知的过敏反应 (10) 患者近期有外科手术损伤,损伤部位为可能黏贴电极的部位等无法完成过电极黏贴及无法完成心电记录 (11) 患者正在参加其他临床试验,并且可能影响本研究的数据收集 (12) 研究者认为有不适合入组的其他情况 (13) 合并使用其他可能对本研究结果造成影响的功能主治类似的中成药 |
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Exclusion criteria: |
(1) Patients with heart valve disease who have indications for surgical or interventional procedures (2) Patients who have had a myocardial infarction, stroke, unstable angina, transient ischemic attack, or hospitalization for acute heart failure within 30 days before enrollment (3) Pregnant women, women preparing for pregnancy, and breastfeeding women (4) Patients who are unable or unwilling to comply with the research protocol and complete follow-up (5) Patients with uncontrolled hyperthyroidism and hypothyroidism, severe infection, severe liver and kidney dysfunction (ALT≥3 times, or/and any formula-calculated eGFR≤30mL/min), malignant tumors, etc. (6) Acute or subacute infective endocarditis (7) Severe pulmonary hypertension of various causes (severe pulmonary hypertension, referring to pulmonary artery systolic pressure>70mmHg) (8) Severe electrolyte disorders, acid-base imbalance (9) Patients with known allergic reactions to adhesives or hydrogel products (10) Patients who have recently had surgical injuries, and the injury site is a possible electrode attachment site, etc., and cannot complete the electrode attachment and ECG recording (11) Patients who are participating in other clinical trials and may affect the data collection of this study (12) Other situations that the researcher believes are not suitable for enrollment (13) Combined use of other similar functional Chinese patent medicines that may affect the results of this study |
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研究实施时间: Study execute time: |
从 From 2023-09-01 00:00:00至 To 2029-08-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2024-05-20 00:00:00 至 To 2026-12-31 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): |
不适用 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
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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: |
不公开/Private |
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盲法: |
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Blinding: |
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是否共享原始数据: IPD sharing |
否No |
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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): |
NA |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
NA |
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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: |
使用纸质和电子CRF表进行数据采集,并通过个人端口手机APP/电脑端上传到EDC系统。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Paper and electronic CRF forms were used for data collection and uploaded to the EDC system through the personal port mobile APP/ computer terminal. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |