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Clinical study of oseltamivir phosphate in the treatment of heart failure with reduced ejection fraction
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注册号:

Registration number:

ChiCTR2100054764 

最近更新日期:

Date of Last Refreshed on:

2022-07-03 

注册时间:

Date of Registration:

2021-12-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件。 磷酸奥司他韦治疗射血分数减低心衰的临床研究 

Public title:

Clinical study of oseltamivir phosphate in the treatment of heart failure with reduced ejection fraction 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

磷酸奥司他韦治疗射血分数减低心衰的临床研究 

Scientific title:

Clinical study of oseltamivir phosphate in the treatment of heart failure with reduced ejection fraction 

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:

许东旭 

研究负责人:

肖平喜 

Applicant:

Xu Dongxu 

Study leader:

Xiao Pingxi 

申请注册联系人电话:

Applicant telephone:

+86 18851728710 

研究负责人电话:

Study leader's telephone:

+86 15077870881 

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:

dongxu_xu@126.com 

研究负责人电子邮件:

Study leader's E-mail:

sysu-xiao@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

南京医科大学附属逸夫医院 

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:

江苏南京市江宁区龙眠大道109号 

研究负责人通讯地址:

江苏南京市江宁区龙眠大道109号 

Applicant address:

109 Longmian Avenue, Jiangning District, Nanjing, Jiangsu 

Study leader's address:

109 Longmian Avenue, Jiangning District, Nanjing, Jiangsu 

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:

南京医科大学附属逸夫医院 

Applicant's institution:

Sir Run Run Hospital, Nanjing Medical University  

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

南京医科大学附属逸夫医院 

Primary sponsor:

Sir Run Run Hospital, Nanjing Medical University  

研究实施负责(组长)单位地址:

江苏南京市江宁区龙眠大道109号 

Primary sponsor's address:

109 Longmian Avenue, Jiangning District, Nanjing, Jiangsu 

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):

南京医科大学附属逸夫医院

具体地址:

江宁区龙眠大道109号

Institution
hospital:

Sir Run Run Hospital, Nanjing Medical University

Address:

109 Longmian Avenue, Jiangning District

经费或物资来源:

无 

Source(s) of funding:

N/A 

研究疾病:

射血分数减低的心力衰竭 

Target disease:

Heart failure with reduced ejection fraction 

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:

使用随机试验评价磷酸奥司他韦治疗射血分数减低心衰(II-IV级)的有效性。 

Objectives of Study:

A randomized trial was used to evaluate the efficacy of oseltamivir phosphate in the treatment of heart failure with reduced ejection fraction (grade II-IV). 

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.临床诊断为心衰患者(NYHA心功能II-IV级); 2.经胸彩色超声心动图检测射血分数减低(LVEF<40%); 3.年龄>18周岁; 4.签署知情同意书。 

Inclusion criteria

1. Patients with clinical diagnosis of heart failure (NYHA cardiac function II-IV); 2. Reduced ejection fraction (LVEF<40%) detected by transthoracic color echocardiography; 3. Age > 18 years old; 4. Sign the informed consent. 

排除标准:

1.终末期肾功能衰竭的患者(内生肌酐清除率eGFR小于30毫升/分钟); 2.神经性疾病患者(癫痫、惊厥等精神性疾病、抑郁症); 3.因其他专科共病如脑梗死偏瘫或骨性关节炎不能正常行走的患者; 4.长期卧床患者; 5.有活动性肝胆胰等消化系统疾病的患者; 6.有活动性胃肠出血患者; 7.有风湿免疫系统疾病患者; 8. 备孕期、妊娠期、哺乳期妇女; 9. 预计生存时间小于一年的恶性肿瘤患者; 10.低血压休克患者(收缩压小于90mmHg,平均压小于60mmHg)。 

Exclusion criteria:

1. Patients with end-stage renal failure (endogenous creatinine clearance eGFR less than 30 ml/min); 2. Patients with neurological diseases (epilepsy, convulsions and other mental diseases, depression); 3. Patients who cannot walk normally due to other comorbidities such as cerebral infarction hemiplegia or osteoarthritis; 4. Long-term bedridden patients; 5. Patients with active hepatobiliary pancreas and other digestive system diseases; 6. Patients with active gastrointestinal bleeding; 7. Patients with rheumatic immune system diseases; 8. Women preparing for pregnancy, pregnancy and lactation; 9. Patients with malignant tumors whose expected survival time is less than one year; 10. Hypotensive shock patients (systolic blood pressure less than 90mmHg, mean blood pressure less than 60mmHg). 

研究实施时间:

Study execute time:

From2021-03-01To 2023-02-28 

征募观察对象时间:

Recruiting time:

From2021-07-01To 2022-01-01 

干预措施:

Interventions:

组别:

试验组VS对照组

样本量:

124

Group:

Test group vs control group

Sample size:

干预措施:

奥司他韦

干预措施代码:

Intervention:

oseltamivir

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):

南京医科大学附属逸夫医院 

单位级别:

三级甲等 

Institution
hospital:

Sir Run Run Hospital, Nanjing Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

六分钟步行距离

指标类型:

主要指标 

Outcome:

Six minute 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:

NT-pro BNP

指标类型:

次要指标 

Outcome:

NT-pro BNP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NYHA心功能分级

指标类型:

次要指标 

Outcome:

NYHA cardiac function classification

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

左室射血分数

指标类型:

次要指标 

Outcome:

Left ventricular ejection fraction

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

左心室舒张末期内径

指标类型:

次要指标 

Outcome:

Left ventricular end-diastolic diameter

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

三尖瓣收缩期位移

指标类型:

次要指标 

Outcome:

Tricuspid annular plane systolic excusion

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Tei指数

指标类型:

次要指标 

Outcome:

Tei index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心肺吸氧运动相关指标

指标类型:

次要指标 

Outcome:

Related indexes of cardiopulmonary oxygen inhalation exercise

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

房颤负荷

指标类型:

次要指标 

Outcome:

burden of Atrial fibrillation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

流感发作次数

指标类型:

次要指标 

Outcome:

Number of influenza attacks

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心衰再住院率

指标类型:

次要指标 

Outcome:

Rehospitalization rate of heart failure

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:

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 years
最大 Max age 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):

简单随机。按照受试者入选的先后顺序,根据预定的随机方案分配入试验组或对照组,本研究拟使用随机信封法,对每个入组对象进行随机。

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

简单随机。按照受试者入选的先后顺序,根据预定的随机方案分配入试验组或对照组,本研究拟使用随机信封法,对每个入组对象进行随机。

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-26
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