达格列净联合复脉汤对射血分数保留型心力衰竭房颤患者心功能及预后情况的影响

注册号:

Registration number:

ITMCTR2025000127

最近更新日期:

Date of Last Refreshed on:

2025-01-16

注册时间:

Date of Registration:

2025-01-16

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

达格列净联合复脉汤对射血分数保留型心力衰竭房颤患者心功能及预后情况的影响

Public title:

The effect of gliflozin combined with Fumai decoction on cardiac function and prognosis in patients with heart failure and atrial fibrillation with preserved ejection fraction

注册题目简写:

English Acronym:

研究课题的正式科学名称:

达格列净联合复脉汤对射血分数保留型心力衰竭房颤患者心功能及预后情况的影响

Scientific title:

The effect of gliflozin combined with Fumai decoction on cardiac function and prognosis in patients with heart failure and atrial fibrillation with preserved ejection fraction

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:

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:

杨洋

研究负责人:

谢大昌

Applicant:

Yang yang

Study leader:

Dachang Xie

申请注册联系人电话:

Applicant telephone:

15949006251

研究负责人电话:

Study leader's telephone:

15005214477

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:

445995802@qq.com

研究负责人电子邮件:

Study leader's E-mail:

15005214477@163.com

申请单位网址(自愿提供):

Study leader's 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:

丰县健康路4002号

研究负责人通讯地址:

丰县健康路4002号

Applicant address:

No. 4002 Jiankang Road Feng County

Study leader's address:

No. 4002 Jiankang Road Feng County

申请注册联系人邮政编码:

Applicant postcode:

221700

研究负责人邮政编码:

Study leader's postcode:

221700

申请人所在单位:

丰县人民医院

Applicant's institution:

Feng County People's Hospital

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

LLSC-2023-022

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

丰县人民医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Feng CountyPeople's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2023/9/14 0:00:00

伦理委员会联系人:

渠时学

Contact Name of the ethic committee:

Shixue Qu

伦理委员会联系地址:

丰县健康路4002号

Contact Address of the ethic committee:

No. 4002 Jiankang Road Feng County

伦理委员会联系人电话:

Contact phone of the ethic committee:

15298708667

伦理委员会联系人邮箱:

Contact email of the ethic committee:

15298708667@163.com

研究实施负责(组长)单位:

丰县人民医院

Primary sponsor:

Feng County People's Hospital

研究实施负责(组长)单位地址:

丰县健康路4002号

Primary sponsor's address:

No. 4002 Jiankang Road Feng County

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):

徐州

Country:

China

Province:

Jiangsu

City:

Xuzhou

单位(医院):

丰县人民医院

具体地址:

丰县健康路4002号

Institution
hospital:

Fengxian People's Hospital

Address:

No. 4002 Jiankang Road Fengxian County

经费或物资来源:

院课题基金

Source(s) of funding:

Hospital Research Fund

研究疾病:

房颤伴射血分数保留型心衰

研究疾病代码:

Target disease:

atrial fibrillation and heart failure with preserved ejection fraction

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

本研究旨在探讨中药复脉汤治疗HFpEF房颤患者的安全性和疗效。

Objectives of Study:

This study aimed to investigate the safety and therapeutic efficacy of herbal drug Fumai decoction in patients affected by heart failure with preserved ejection fraction(HFpEF) and atrial fibrillation.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)年龄46-80周岁; (2)通过询问病史、体格检查以及既往及入院后的12导联心电图、24小时动态心电图(Holter)确定符合非瓣膜病变AF的HFpEF诊断标准的患者。BNP ≥ 105 pg/ml 或 NT-proBNP ≥ 365 pg/mL。超声提示心脏结构或舒张功能改变; (3)参与本研究前一周内未接受HFpEF 标准规范治疗; (4)签署知情同意书。

Inclusion criteria

(1) age 46-80 years old; (2) Patients who met the diagnostic criteria of HFpEF with non-valvular AF were identified by medical history physical examination 12-lead electrocardiogram (ECG) and 24-hour Holter (Holter). BNP ≥ 105 pg/ml or NT-proBNP ≥ 365 pg/mL. Echocardiography showed any changes in cardiac structure or diastolic function. (3) HFpEF patients had not received standard treatment within one week before the study; (4) Informed consent was signed.

排除标准:

(1)严重心脏瓣膜病、先天性心脏病、风湿性心脏病、肥厚型梗阻性心肌病、心包疾病、肝肾功能不全、脱水患者、不能正常进食和饮水、持续呕吐、腹泻,发热、对活性物质或辅料过敏、1型糖尿病、在使用SGLT2i时曾有DKA的患者;恶性肿瘤或免疫疾病患者;精神疾病患者。 (2)无法或拒绝完成研究。

Exclusion criteria:

Exclusion criteria: (1) Severe valvular congenital or rheumatic heart disease; hypertrophic obstructive cardiomyopathy; pericardial disease; hepatic or renal insufficiency; dehydration; inability to tolerate oral intake; persistent vomiting or diarrhea; fever; allergy to study medication; type 1 diabetes mellitus; history of diabetic ketoacidosis (DKA) while taking SGLT2i; malignancy; immune disorders; mental illness. (2) Inability or refusal to complete the study.

研究实施时间:

Study execute time:

From 2023-09-14

To      2024-09-14

征募观察对象时间:

Recruiting time:

From 2023-09-14

To      2024-09-14

干预措施:

Interventions:

组别:

观察组

样本量:

55

Group:

Observation group

Sample size:

干预措施:

复脉汤+包括达格列净在内的指南推荐最优药物治疗

干预措施代码:

Intervention:

Fumai decoction+OMT

Intervention code:

组别:

对照组

样本量:

55

Group:

Control group

Sample size:

干预措施:

安慰剂+包括达格列净在内的指南推荐最优药物治疗

干预措施代码:

Intervention:

placebo +OMT

Intervention code:

样本总量 Total sample size : 110

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):

徐州

Country:

China

Province:

Jangsu

City:

Xuzhou

单位(医院):

丰县人民医院

单位级别:

三级乙等

Institution/hospital:

Fengxian People's Hospital

Level of the institution:

Tertiary B hospital

测量指标:

Outcomes:

指标中文名:

心脏彩超左室射血分数

指标类型:

次要指标

Outcome:

LVEF

Type:

Secondary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

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:

入组时/入组后4w,8w,12w

测量方法:

患者报告结局(PRO)、临床医生报告资料(ClinRO)、看护人员报告资料(ObseRO)等相关量表。

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

Measure method:

Patient-reported outcomes (PRO), Clinician-reported data (ClinRO), caregiver-reported data (ObseRO) and other related scales.

指标中文名:

中医证候疗效评价

指标类型:

次要指标

Outcome:

The TCM syndrome score

Type:

Secondary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

中医证候评分包括主症和次症共同积分的改变,气短、喘息、乏力、心悸、水肿主症,倦怠懒言、自汗、语声低微、咽干等次症,结合舌苔脉象,症状由轻到重分别记0分、2分、4分、6分。

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

Measure method:

The TCM syndrome score included the changes of the common score of the main symptoms and secondary symptoms, shortness of breath, wheezing, fatigue, palpitation, edema, tiredness, lazy speech, spontaneous sweating, low voice, dry throat and other secondary symptoms. Combined with the tongue coating and pulse, the symptoms from mild to severe were scored 0 points, 2 points, 4 points, and 6 points, respectively.

指标中文名:

堪萨斯城心肌病问卷(KCCQ)

指标类型:

次要指标

Outcome:

The Kansas city cardiomyopathy questionnaire(KCCQ))

Type:

Secondary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

Measure time point of outcome:

At the time of joining/after joining4w8w12w

Measure method:

指标中文名:

N末端B型钠尿肽前体

指标类型:

次要指标

Outcome:

NT-proBNP

Type:

Secondary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

Measure method:

指标中文名:

死亡

指标类型:

主要指标

Outcome:

death

Type:

Primary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

患者报告结局(PRO)、临床医生报告资料(ClinRO)、看护人员报告资料(ObseRO)等相关量表

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

Measure method:

Patient-reported outcomes (PRO), Clinician-reported data (ClinRO), caregiver-reported data (ObseRO) and other related scales

指标中文名:

明尼苏达心力衰竭生活质量调查表(MLHF问卷)

指标类型:

次要指标

Outcome:

Quality-of-life assessment of the Minnesota Living with Heart Failure Questionnaire (MLHF questionnaire)

Type:

Secondary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

MLHF问卷

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

Measure method:

MLHF questionnaire

指标中文名:

6分钟步行试验距离

指标类型:

次要指标

Outcome:

6-minute walk test (6MWT)

Type:

Secondary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标

Outcome:

CRP

Type:

Secondary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

Measure method:

指标中文名:

心衰再住院 试验过程中因慢性心衰急性加重,需住院或急诊就诊(静脉使用利尿剂或血管活性药物)

指标类型:

次要指标

Outcome:

Hospitalization for heart failure that resulted in an acute exacerbation of chronic heart failure that required hospitalization or an emergency department visit (with intravenous diuretics or vasoactive agents) during the course of the trial.

Type:

Secondary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

患者报告结局(PRO)、临床医生报告资料(ClinRO)、看护人员报告资料(ObseRO)等相关量表

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

Measure method:

Patient-reported outcomes (PRO), Clinician-reported data (ClinRO), caregiver-reported data (ObseRO) and other related scales.

指标中文名:

其他心血管事件再住院

指标类型:

次要指标

Outcome:

Patients who were readmitted due to other cardiovascular events .

Type:

Secondary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

患者报告结局(PRO)、临床医生报告资料(ClinRO)、看护人员报告资料(ObseRO)等相关量表

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

Measure method:

Patient-reported outcomes (PRO), Clinician-reported data (ClinRO), caregiver-reported data (ObseRO) and other related scales.

指标中文名:

心脏彩超左心室舒张早期二尖瓣血流最大速度(E)/舒张早期二尖瓣环峰值速度(e’)

指标类型:

次要指标

Outcome:

E/e'

Type:

Secondary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

Measure method:

指标中文名:

可溶性晚期糖基化终产物受体

指标类型:

次要指标

Outcome:

sRAGE

Type:

Secondary indicator

测量时间点:

入组时/入组后4w,8w,12w

测量方法:

Measure time point of outcome:

At the time of joining/after joining4w,8w,12w

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:

结束

Completed

年龄范围:

最小 46
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

一名未参与患者评估的医生使用SPSS 25.0软件进行了计算机生成的随机化程序随机分配序列,参与者根据疾病的严重程度、年龄、性别按1:1的比例随机分配到两个不同的治疗组。

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

A doctor who was not involved in the evaluation of patients used SPSS 23.0 software to conduct the computer-generated randomization program. Participants were randomly assigned to two different treatment groups in a 1:1 ratio based on disease severity age and sex.

盲法:

Blinding:

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):

2015至2016年,期刊

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

2015-2016,Periodical

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:

1.病例记录表(CRF)的填写与移交: 完成的病例报告表由临床研究者和监察员审查后,交数据统计单位,进行数据录入与管理工作。所有过程均需方案记录。 2.电子采集和管理系统数据的录入与修改: 数据录入与管理由统计单位数据管理员负责。采用 EpiData2.1数据库,进行数据录入与管理。为保证数据的准确性,应由两个数据管理员独立进行双份录入并校对。对病例报告表中存在的疑问。数据管理员将填写疑问解答表(DRO),并通过临床监查员向研究者发出询问,研究者应尽快解答并返回,数据管理员根据研究者的回答进行数据修改,确认与录入,必要时可以再次发出 DRO。

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

1. Completion and handover of case record Form (CRF) : The completed case report forms were reviewed by clinical investigators and monitors and then submitted to the statistical unit for data entry and management. Protocol documentation was required for all procedures. 2. Data entry and modification of electronic collection and management system: Data entry and management were undertaken by the data manager of the statistical unit. EpiData2.1 database was used for data entry and management. To ensure the accuracy of the data duplicate entry and proofreading should be done independently by two data managers. Questions about the case report form. The data manager will fill out the Question Answer Form (DRO) and send a query to the investigator through the clinical monitor. The investigator should answer and return it as soon as possible. The data manager will modify confirm and enter the data according to the investigator's answers and the DRO can be issued again if necessary.\

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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