ChiCTR2600124136 版本V1.0 版本创建时间2026/05/07 17:37:12 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：

 ChiCTR2600124136 

最近更新日期：

Date of Last Refreshed on：

 2026-05-07 17:37:00 

注册时间：

Date of Registration：

 2026-05-07 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于呼出气醛酮类挥发性有机物富集技术与便携质谱的心力衰竭数智中医嗅诊方法研究

Public title：

Research on Olfactory Diagnosis of Smart Traditional Chinese Medicine for Heart Failure Based on Enrichment Technology of Aldehyde and Ketone Volatile Organic Compounds in Exhaled Breath and Portable Mass Spectrometry

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于呼出气醛酮类挥发性有机物富集技术与便携质谱的心力衰竭数智中医嗅诊方法研究

Scientific title：

Research on Olfactory Diagnosis of Smart Traditional Chinese Medicine for Heart Failure Based on Enrichment Technology of Aldehyde and Ketone Volatile Organic Compounds in Exhaled Breath and Portable Mass Spectrometry

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：

钟瑞 

研究负责人：

钟瑞 张玫 

Applicant：

Zhong Rui 

Study leader：

Zhong Rui, Zhang Mei 

申请注册联系人电话：

Applicant telephone：

 +86 132 9265 1633

研究负责人电话：

Study leader's
telephone：

+86 138 1002 1517

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：

 ruizhong1015@163.com

研究负责人电子邮件：

Study leader's E-mail：

 meizhang@bucm.edu.cn

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：

中国北京市房山区良乡高教园区昊天街9号

研究负责人通讯地址：

中国北京市房山区良乡高教园区昊天街9号

Applicant address：

9 Haotian Street, Liangxiang Higher Education Park, Fangshan District, Beijing, China

Study leader's address：

9 Haotian Street, Liangxiang Higher Education Park, Fangshan District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

 102488

研究负责人邮政编码：

Study leader's postcode：

 102488

申请人所在单位：

北京中医药大学

Applicant's institution：

Beijing University of Chinese Medicine

研究负责人所在单位：

北京中医药大学

Affiliation of the Leader：

Beijing University of Chinese Medicine

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：

 2026BZYLL0302

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

北京中医药大学医学伦理委员会

Name of the ethic committee：

Committee of Beijing University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-12 00:00:00

伦理委员会联系人：

崔清爽、赵丽红

Contact Name of the ethic committee：

Cui Qingshuang, Zhao Lihong

伦理委员会联系地址：

中国北京市房山区良乡高教园区昊天街9号

Contact Address of the ethic committee：

9 Haotian Street, Liangxiang Higher Education Park, Fangshan District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 5391 1431

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：

北京中医药大学

Primary sponsor：

Beijing University of Chinese Medicine

研究实施负责（组长）单位地址：

中国北京市房山区良乡高教园区昊天街9号

Primary sponsor's address：

9 Haotian Street, Liangxiang Higher Education Park, Fangshan District, Beijing, 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)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京中医药大学

具体地址：

中国北京市房山区良乡高教园区昊天街9号

Institution
hospital：

Beijing University of Chinese Medicine

Address：

9 Haotian Street, Liangxiang Higher Education Park, Fangshan District, Beijing, China

经费或物资来源：

“十四五”国家重点研发计划（2022YFC3502305）

Source(s) of funding：

National Key Research and Development Program of the 14th Five-Year Plan (2022YFC3502305)

研究疾病：

心力衰竭  

Target disease：

Heart failure

研究疾病代码：

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

诊断试验诊断准确性 

Study design：

Diagnostic test for accuracy 

研究目的：

本研究旨在开发一种基于呼出气中醛酮类挥发性有机物富集技术与便携质谱的数智中医嗅诊方法，探索挥发性有机化合物在心力衰竭与健康人呼出气中的特异性，为基于呼出气的中医嗅诊信息采集与分析装备、模型研发提供临床数据收集渠道，以期为心衰早期风险预警提供一种成本低廉、操作简便、无创快速的新途径，并避免有创检测给患者带来的痛苦与不便。  

Objectives of Study：

This study aims to develop an olfactory diagnosis method of smart traditional Chinese medicine based on the enrichment technology of aldehyde and ketone volatile organic compounds (VOCs) in exhaled breath and portable mass spectrometry. It explores the specificity of VOCs in the exhaled breath of patients with heart failure versus healthy individuals. The goal is to provide a clinical data collection channel for the development of equipment and models for TCM olfactory diagnosis information acquisition and analysis based on exhaled breath. It is anticipated that this will offer a new pathway for early risk warning of heart failure, characterized by low cost, simple operation, non-invasiveness, and rapidity, thereby avoiding the pain and inconvenience associated with invasive testing for patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

病例组纳入标准： 1.符合《中国心力衰竭诊断和治疗指南2024》心力衰竭诊断标准； 2.符合《慢性心力衰竭中医诊疗指南》（2022年）诊断标准； 3.性别不限；年龄30-85岁； 4.患者知情同意，并自愿签署知情同意书； 5.能够理解并配合完成研究流程，依从性好，能配合3次呼气者。 健康组纳入标准： 1.性别不限，年龄在30 ~ 85岁之间，且近2周内无吸烟史者； 2.无呼吸道症状（如咳嗽、咳痰、咯血、气短、呼吸困难或胸痛）者； 3.能够理解并配合完成研究流程，依从性好，能配合3次呼气者； 4.本人知情同意，并自愿签署知情同意书； 5.没有明显影响生产生活的循环系统、神经系统、消化系统、呼吸系统、免疫系统、运动系统、泌尿系统、生殖系统疾病的人，包括医师判断明显影响本项目信息收集的各类严重慢性病、恶性疾病、精神疾病，如严重肝、肾功能不全，恶性肿瘤，严重焦虑、抑郁等。健康人群可以是医护、学生、体检者等稳定人群，同地域的其他病种研究，健康人资料可共享使用。

Inclusion criteria

Inclusion Criteria for the Case Group: 1. Meeting the diagnostic criteria for heart failure as outlined in the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024; 2.Meeting the diagnostic criteria specified in the Guidelines for the Diagnosis and Treatment of Chronic Heart Failure in Traditional Chinese Medicine (2022); 3.No restriction on gender; age between 30 and 85 years; 4.The patient is informed and provides consent, voluntarily signing the informed consent form; 5. Able to understand and cooperate with the study procedures, with good compliance, and able to cooperate for three breath collections. Inclusion Criteria for the Healthy Control Group: 1. No restriction on gender; age between 30 and 85 years, with no history of smoking in the past two weeks; 2. No respiratory symptoms (e.g., cough, expectoration, hemoptysis, shortness of breath, dyspnea, or chest pain); 3.Able to understand and cooperate with the study procedures, with good compliance, and able to cooperate for three breath collections; 4.The individual is informed and provides consent, voluntarily signing the informed consent form; 5. No significant diseases affecting daily life and work in the circulatory, nervous, digestive, respiratory, immune, musculoskeletal, urinary, or reproductive systems. This includes any severe chronic diseases, malignant diseases, or mental disorders deemed by a physician to significantly interfere with the information collection for this project, such as severe hepatic or renal insufficiency, malignant tumors, severe anxiety, depression, etc. Healthy individuals may include stable populations such as healthcare workers, students, or individuals undergoing routine physical examinations. Data from healthy controls in other disease studies conducted in the same region may be shared and utilized.

排除标准：

1.合并心源性休克、急性心肌炎、难以控制的恶性心律失常、肥厚梗阻性心肌病、缩窄性心包炎、心包填塞、严重瓣膜病需要手术治疗及肺动脉栓塞者等； 2.近期发生非心脏原因可影响运动能力的疾病，或患有可因运动而加剧病情的疾病（如感染，肝肾功能衰竭、甲状腺毒症等）； 3.近4周内因心力衰竭急性加重住院治疗者，或纽约心脏病协会心功能分级为IV级者； 4.存在任何可能影响呼出气代谢谱的慢性疾病（如未控制的糖尿病、甲状腺功能异常、慢性肝病、慢性肾病）； 5.非心衰原因导致的肝脏转氨酶（ALT或AST）超出3倍正常值上限，肾小球滤过率＜ 15 mL/(min·1.73 m2)，血钾＞ 5.5 mmol/L； 6.合并肝、肾、造血系统、神经系统、内分泌系统等严重原发性疾病、肿瘤患者及精神病患者； 7.合并代谢性疾病，如糖尿病酮症酸中毒等患者； 8.存在自身免疫性疾病如系统性红斑狼疮、类风湿关节炎者； 9.计划妊娠、妊娠期或哺乳期妇女； 10.怀疑或确有酒精、药物滥用者； 11.因其他原因不能配合3次呼气者； 12.研究者认为其他不适合参加本次临床试验者。

Exclusion criteria：

1. Comorbid conditions including cardiogenic shock, acute myocarditis, uncontrolled malignant arrhythmia, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, severe valvular heart disease requiring surgical intervention, and pulmonary embolism; 2. Recent occurrence of non-cardiac diseases that may affect exercise capacity, or presence of any disease that may be exacerbated by exercise (e.g., infection, hepatic or renal failure, thyrotoxicosis, etc.); 3. Hospitalization for acute exacerbation of heart failure within the past 4 weeks, or New York Heart Association (NYHA) functional class IV; 4. Presence of any chronic disease that may affect the exhaled breath metabolome (e.g., uncontrolled diabetes, thyroid dysfunction, chronic liver disease, chronic kidney disease); 5. Hepatic transaminase (ALT or AST) levels exceeding 3 times the upper limit of normal due to non-heart failure causes, estimated glomerular filtration rate (eGFR) < 15 mL/(min·1.73 m2), or serum potassium > 5.5 mmol/L; 6. Comorbid severe primary diseases of the liver, kidney, hematopoietic system, nervous system, endocrine system, etc.; patients with tumors; and patients with mental disorders; 7.Comorbid metabolic diseases, such as diabetic ketoacidosis; 8.Presence of autoimmune diseases, such as systemic lupus erythematosus or rheumatoid arthritis; 9. Women who are planning pregnancy, are pregnant, or are lactating; 10.Suspected or confirmed alcohol or substance abuse; 11. Inability to cooperate for three breath collections due to other reasons; 12Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

研究实施时间：

Study execute time：

从 From 2024-01-03 00:00:00至 To 2028-03-12 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-01-03 00:00:00 至 To 2028-03-12 00:00:00

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

西医诊断标准： 参考《中国心力衰竭诊断和治疗指南 2024》心力衰竭诊断标准。 中医诊断标准： 参考《慢性心力衰竭中医诊疗指南》（2022 年）诊断标准。

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Western medical diagnostic criteria: Refer to the diagnostic criteria for heart failure in the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024". The diagnostic criteria for traditional Chinese medicine: Refer to the diagnostic criteria in the "Guidelines for the Diagnosis and Treatment of Chronic Heart Failure in Traditional Chinese Medicine" (2022).

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

基于呼出气中醛酮类挥发性有机物富集技术与便携质谱的数智中医嗅诊方法

Index test:

A digital and intelligent traditional Chinese medicine olfactory diagnosis method based on the enrichment technology of aldehyde and ketone volatile organic compounds in exhaled breath and portable mass spectrometry

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

心力衰竭患者

例数:

Sample size:

110

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients with heart failure

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

无

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

None

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 北京中医药大学 

单位级别：

 大学 

Institution
hospital：

Beijing University of Chinese Medicine

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

模型灵敏度与特异度

指标类型：

主要指标

Outcome：

Sensitivity and Specificity of the Model

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼出气 VOCs 成分及含量

指标类型：

次要指标

Outcome：

Composition and Concentration of Volatile Organic Compounds in Exhaled Breath

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

一般资料（姓名缩写、病案号、收集时间、出生日期、年龄、性别、身高、体重、体温、血压、脉搏、呼吸）

指标类型：

次要指标

Outcome：

General Demographic Information (Initials, Medical Record Number, Collection Time, Date of Birth, Age, Sex, Height, Weight, Body Temperature, Blood Pressure, Pulse Rate, Respiratory Rate)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

基本病史及疾病诊断（发病诱因、发病季节、吸烟饮酒史、体温、心率、血压、呼吸、心功能分级、既往病史、药物过敏史及家族史）

指标类型：

次要指标

Outcome：

Basic Medical History and Diagnosis (Etiological Factors, Season of Onset, Smoking and Alcohol History, Body Temperature, Heart Rate, Blood Pressure, Respiratory Rate, NYHA Functional Class, Past Medical History, Drug Allergy History, Family History)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

症状与体征（胸痛、胸闷、心悸、气短、下肢水肿、头晕、头痛、舌象、脉象、中医证候要素、中医证型、呼吸困难 VAS 评分、双下肢水肿程度、NYHA 心功能分级）

指标类型：

次要指标

Outcome：

Symptoms and Physical Signs (Chest Pain, Chest Tightness, Palpitations, Dyspnea, Lower Limb Edema, Dizziness, Headache, Tongue Appearance, Pulse Quality, TCM Syndrome Elements, TCM Syndrome Type, Dyspnea VAS Score, Severity of Bilateral Lower Limb Edema, NYHA Functional Class)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

实验室指标（肌酸激酶同工酶 CK-MB、肌钙蛋白 cTnI/T、NT-proBNP、尿常规、血常规、生化全项、凝血功能、心电图、超声心动图、超敏肌钙蛋白 T hs-cTnT、空腹血糖 Glu、低密度脂蛋白胆固醇 LDL-C、肾小球滤过率 eGFR、BMI）

指标类型：

次要指标

Outcome：

Laboratory Parameters (Creatine Kinase MB Isoenzyme CK-MB, Cardiac Troponin cTnI/T, NT-proBNP, Urinalysis, Complete Blood Count, Biochemistry Panel, Coagulation Function, Electrocardiogram, Echocardiography, High-Sensitivity Troponin T hs-cTnT, Fasting Glucose Glu, Low-Density Lipoprotein Cholesterol LDL-C, Estimated Glomerular Filtration Rate eGFR, Body Mass Index BMI)

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：

呼出气

组织：

Sample Name：

Exhaled breath

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 30 岁 years
最大 Max age 85 岁 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）：

本研究非随机对照研究

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

This study is a non-randomized controlled study.

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

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

是Yes

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）：

研究结束后半年；国家生物信息中心(https://www.cncb.ac.cn/)

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

Six months after the completion of the research; China National Center for Bioinformation (https://www.cncb.ac.cn/)

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：

本研究采用电子版CRF，采用 Excel 进行数据录入

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

Our study uses the electronic version of CRF, Excel was used for data entry.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-05-07 17:37:00