ChiCTR2500115367 版本V1.0 版本创建时间2025/12/25 09:07:47 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：

 ChiCTR2500115367 

最近更新日期：

Date of Last Refreshed on：

 2025-12-25 09:07:41 

注册时间：

Date of Registration：

 2025-12-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

表观难治性高血压患者的预后分析

Public title：

Prognostic Analysis of Patients with Apparent Treatment-Resistant Hypertension

注册题目简写：

English Acronym：

研究课题的正式科学名称：

表观难治性高血压患者的预后分析

Scientific title：

Prognostic Analysis of Patients with Apparent Treatment-Resistant Hypertension

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：

严晓伟 

研究负责人：

严晓伟 

Applicant：

Xiaowei Yan 

Study leader：

Xiaowei Yan 

申请注册联系人电话：

Applicant telephone：

 +86 13701178433

研究负责人电话：

Study leader's
telephone：

+86 13701178433

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：

 xswy_pumc@163.com

研究负责人电子邮件：

Study leader's E-mail：

 xswy_pumc@163.com

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：

北京市东城区帅府园1号北京协和医院

研究负责人通讯地址：

王府井帅府园1号（100730）

Applicant address：

Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing

Study leader's address：

No.1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing

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：

中国医学科学院北京协和医院

Applicant's institution：

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

研究负责人所在单位：

中国医学科学院北京协和医院

Affiliation of the Leader：

Peking Union Medical College Hospital

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：

 I-25PJ3146

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：

中国医学科学院北京协和医院伦理审查委员会

Name of the ethic committee：

PUMCH Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-24 00:00:00

伦理委员会联系人：

李佳月

Contact Name of the ethic committee：

Jiayue Li

伦理委员会联系地址：

王府井帅府园1号（100730）

Contact Address of the ethic committee：

No.1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 69156874

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 dott1994@163.com

研究实施负责（组长）单位：

中国医学科学院北京协和医院

Primary sponsor：

Peking Union Medical College Hospital

研究实施负责（组长）单位地址：

王府井帅府园1号（100730）

Primary sponsor's address：

No.1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing

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

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国医学科学院北京协和医院

具体地址：

王府井帅府园1号（100730）

Institution
hospital：

Peking Union Medical College Hospital

Address：

No.1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing

经费或物资来源：

中央高水平医院临床科研专项

Source(s) of funding：

National High Level Hospital Clinical Research Funding

研究疾病：

表观难治性高血压（apparent treatment-Resistant Hypertension，aTRH）定义为使用３种降压药（通常包括长效钙通道阻滞剂，肾素-血管紧张素-醛固酮系统抑制剂和1种利尿剂，通常为噻嗪类利尿剂）血压仍不能达标（BP≥140/90mmHg，合并糖尿病或CKD患者BP≥130/80mmHg）或使用≥４种降压药物的情况（无论血压控制水平）  

Target disease：

Apparent treatment-resistant hypertension (aTRH) is defined as the failure to achieve target blood pressure (BP ≥ 140/90 mmHg, BP ≥ 130/80 mmHg in patients with diabetes or CKD) despite the use of three antihypertensive drugs (usually including a long-acting calcium channel blocker, a renin-angiotensin-aldosterone system inhibitor, and a diuretic, usually a thiazide diuretic) or the use of ≥ 4 ant

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

探索影响表观难治性高血压患者血压、血压达标状态、高血压介导的靶器官损害及临床结局的风险因素。  

Objectives of Study：

To explore the risk factors affecting blood pressure, hypertension-mediated target organ damage, and clinical outcomes in patients with apparent treatment-resistant hypertension.

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>=18岁且<=70岁的成年男性或女性患者； 2.符合表观难治性高血压的诊断，且合并2型糖尿病； 3.至少在北京协和医院门诊就诊3次且有完整的诊室血压记录，首次门诊距最近一次门诊就诊时间间隔不小于6个月；

Inclusion criteria

1.Adult male or female patients aged >=18 years and <=70 years; 2.Diagnosed with apparent resistant hypertension and type 2 diabetes; 3.Having visited the outpatient clinic of Peking Union Medical College Hospital at least three times with complete office blood pressure records, with the interval between the first outpatient visit and the most recent outpatient visit being no less than six months;

排除标准：

1.存在任何限制预期寿命的严重伴随疾病，如恶性肿瘤； 2.存在导致继发性高血压的病因（例如，肾动脉狭窄、未控制或未治疗的甲状腺功能亢进症、未控制或未治疗的甲状腺功能减退症、甲状旁腺功能亢进症、嗜铬细胞瘤、库欣综合征或主动脉缩窄）。阻塞性睡眠呼吸暂停不在此列。 3.严重的肾功能不全（eGFR＜30 mL/min/1.73m^2）； 4.病态肥胖（BMI＞40 kg/m^2）； 5.怀孕、哺乳或计划怀孕； 6.1型糖尿病； 7.研究前3个月内曾发生过心血管及肾脏不良事件； 8.治疗依从性欠佳；

Exclusion criteria：

1.Presence of any serious comorbidity that limits life expectancy, such as malignancy; 2.Presence of a cause of secondary hypertension (e.g., renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome, or coarctation of the aorta). Obstructive sleep apnea is not included. 3.Severe renal insufficiency (eGFR < 30 mL/min/1.73m^2); 4.Morbid obesity (BMI > 40 kg/m^2); 5.Pregnancy, breastfeeding, or planning pregnancy; 6.Type 1 diabetes; 7.Adverse cardiovascular and renal events within 3 months before the study; 8.Poor medication compliance;

研究实施时间：

Study execute time：

从 From 2025-10-20 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-31 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 2500

Group：

Control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

暴露组

样本量：

 2500

Group：

Exposed Group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 中国医学科学院北京协和医院 

单位级别：

 三级甲等 

Institution
hospital：

Peking Union Medical College Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

肾脏事件

指标类型：

次要指标

Outcome：

Renal event

Type：

Secondary indicator

测量时间点：

随访

测量方法：

通过门诊复诊及电话对患者或患者家属进行随访，询问是否发生肾脏事件。肾脏事件包括白蛋白尿的进展（定义为白蛋白尿增加超过基线的30%，并且从正常白蛋白尿进展为微量白蛋白尿[ACR≥30 mg/g]或大量白蛋白尿[ACR≥300 mg/g]，或微量白蛋白尿进展为大量白蛋白尿）或eGFR（采用慢性肾脏病流行病学协作方程计算）下降超过50%或需要长期透析的终末期肾功能衰竭或需要肾脏移植。

Measure time point of outcome：

follow-up

Measure method：

Through outpatient follow-up and telephone consultations, patients or their family members are contacted to inquire about any renal events that have occurred. Renal events include the progression of albuminuria (defined as an increase in albuminuria exceeding 30% from baseline, and progression from normal albuminuria to microalbuminuria [ACR ≥ 30 mg/g] or macroalbuminuria [ACR ≥ 300 mg/g], or progression from microalbuminuria to macroalbuminuria) or a decline in eGFR (calculated using CKD-EPI） o

指标中文名：

收缩压的变化

指标类型：

次要指标

Outcome：

Changes in systolic blood pressure

Type：

Secondary indicator

测量时间点：

基线、随访

测量方法：

通过调阅医院电子病历系统，检索基线及随访期间的诊室血压数据，通过电话对患者或患者家属进行随访，获取家庭自测血压的数据。诊室血压的测量方法：测量前静坐休息 5分钟以上，采用经认证的上臂式电子血压计，选择合适的袖带尺寸，手臂裸露，袖带中心与心脏处于同一水平，连续测量两次，间隔1-2分钟，取两次血压测量值的平均值作为诊室血压。

Measure time point of outcome：

Baseline, follow-up

Measure method：

The clinic blood pressure data at baseline and during follow-up were retrieved by accessing the hospital's electronic medical record system, and the patients or their families were followed up by telephone to obtain the data of self-measured blood pressure at home.Method for measuring blood pressure: Sit and rest for more than 5 minutes before measurement, use a certified upper arm electronic blood pressure monitor, select an appropriate cuff size, expose your arm, and place the center of the cu

指标中文名：

舒张压达标率

指标类型：

次要指标

Outcome：

The achievement rate of target diastolic blood pressure

Type：

Secondary indicator

测量时间点：

基线、随访

测量方法：

通过调阅医院电子病历系统，检索基线及随访期间的诊室血压数据，通过电话对患者或患者家属进行随访，获取家庭自测血压的数据。诊室血压的测量方法：测量前静坐休息 5分钟以上，采用经认证的上臂式电子血压计，选择合适的袖带尺寸，手臂裸露，袖带中心与心脏处于同一水平，连续测量两次，间隔1-2分钟，取两次血压测量值的平均值作为诊室血压。

Measure time point of outcome：

Baseline, follow-up

Measure method：

The clinic blood pressure data at baseline and during follow-up were retrieved by accessing the hospital's electronic medical record system, and the patients or their families were followed up by telephone to obtain the data of self-measured blood pressure at home.Method for measuring blood pressure: Sit and rest for more than 5 minutes before measurement, use a certified upper arm electronic blood pressure monitor, select an appropriate cuff size, expose your arm, and place the center of the cu

指标中文名：

收缩压达标率

指标类型：

次要指标

Outcome：

The achievement rate of target systolic blood pressure

Type：

Secondary indicator

测量时间点：

基线、随访

测量方法：

通过调阅医院电子病历系统，检索基线及随访期间的诊室血压数据，通过电话对患者或患者家属进行随访，获取家庭自测血压的数据。诊室血压的测量方法：测量前静坐休息 5分钟以上，采用经认证的上臂式电子血压计，选择合适的袖带尺寸，手臂裸露，袖带中心与心脏处于同一水平，连续测量两次，间隔1-2分钟，取两次血压测量值的平均值作为诊室血压。

Measure time point of outcome：

Baseline, follow-up

Measure method：

The clinic blood pressure data at baseline and during follow-up were retrieved by accessing the hospital's electronic medical record system, and the patients or their families were followed up by telephone to obtain the data of self-measured blood pressure at home.Method for measuring blood pressure: Sit and rest for more than 5 minutes before measurement, use a certified upper arm electronic blood pressure monitor, select an appropriate cuff size, expose your arm, and place the center of the cu

指标中文名：

NYHA心功能分级

指标类型：

次要指标

Outcome：

NYHA Functional Classification

Type：

Secondary indicator

测量时间点：

随访

测量方法：

基于详细的病史询问和临床访谈，明确“受限原因”，询问日常活动，量化活动水平，匹配分级标准。

Measure time point of outcome：

follow-up

Measure method：

Based on a detailed medical history inquiry and clinical interview, identify the "reason for limitation," inquire about daily activities, quantify activity levels, and match the grading standards.

指标中文名：

舒张压的变化

指标类型：

次要指标

Outcome：

Changes in diastolic blood pressure

Type：

Secondary indicator

测量时间点：

基线、随访

测量方法：

通过调阅医院电子病历系统，检索基线及随访期间的诊室血压数据，通过电话对患者或患者家属进行随访，获取家庭自测血压的数据。诊室血压的测量方法：测量前静坐休息 5分钟以上，采用经认证的上臂式电子血压计，选择合适的袖带尺寸，手臂裸露，袖带中心与心脏处于同一水平，连续测量两次，间隔1-2分钟，取两次血压测量值的平均值作为诊室血压。

Measure time point of outcome：

Baseline, follow-up

Measure method：

The clinic blood pressure data at baseline and during follow-up were retrieved by accessing the hospital's electronic medical record system, and the patients or their families were followed up by telephone to obtain the data of self-measured blood pressure at home.Method for measuring blood pressure: Sit and rest for more than 5 minutes before measurement, use a certified upper arm electronic blood pressure monitor, select an appropriate cuff size, expose your arm, and place the center of the cu

指标中文名：

心源性死亡

指标类型：

次要指标

Outcome：

Cardiovascular death

Type：

Secondary indicator

测量时间点：

随访

测量方法：

通过电话对患者家属进行随访，询问是否发生心源性死亡事件。心源性死亡被定义为：包括因冠心病、中风、心力衰竭和其他心血管原因，诸如心脏瓣膜病、非缺血性心肌病、原发性心律失常、腹主动脉瘤破裂、急性肢体缺血和心源性猝死等所导致的死亡。

Measure time point of outcome：

follow-up

Measure method：

Patients' families were followed up by telephone to inquire about any cardiac death that occurred. Cardiac death was defined as death due to coronary heart disease, stroke, heart failure, and other cardiovascular causes, such as valvular heart disease, nonischemic cardiomyopathy, primary arrhythmia, ruptured abdominal aortic aneurysm, acute limb ischemia, and sudden cardiac death.

指标中文名：

全因死亡

指标类型：

次要指标

Outcome：

All cause mortality

Type：

Secondary indicator

测量时间点：

随访

测量方法：

通过电话对患者家属进行随访，询问是否发生全因死亡事件。全因死亡的确认方法：使用所有可用信息确认死亡的事实、日期和原因，包括死亡证明、死亡前最后一次住院记录、最终裁决结果、病史以及亲属、联系人或证人提供的关于死亡情况和表现的描述。

Measure time point of outcome：

follow-up

Measure method：

Follow-up with the patient's family by telephone to inquire about any all-cause death. Methods for confirmation of all-cause death: Confirm the fact, date, and cause of death using all available information, including the death certificate, the last hospitalization record before death, the final adjudication, the medical history, and the description of the circumstances and manifestations of death provided by relatives, contacts, or witnesses.

指标中文名：

心力衰竭

指标类型：

次要指标

Outcome：

Heart failure

Type：

Secondary indicator

测量时间点：

随访

测量方法：

通过门诊复诊及电话对患者或患者家属进行随访，询问是否发生心力衰竭事件。心力衰竭被定义为由于心力衰竭的临床表现而需要入院或急诊就诊的事件，例如存在呼吸困难、运动耐量下降、外周水肿、第三心音、肺充血或胸部X光片上的心脏扩张、超声心动图上的收缩/舒张功能障碍并需要治疗。

Measure time point of outcome：

follow-up

Measure method：

Patients or their families were followed up through outpatient follow-up visits and telephone calls to inquire about the occurrence of heart failure events. Heart failure was defined as an event requiring hospitalization or emergency department visit due to clinical manifestations of heart failure, such as the presence of dyspnea, decreased exercise tolerance, peripheral edema, third heart sound, pulmonary congestion or cardiac dilatation on chest X-ray, and systolic/diastolic dysfunction on ech

指标中文名：

主要不良心血管及肾脏事件

指标类型：

主要指标

Outcome：

major adverse cardiovascular and renal events

Type：

Primary indicator

测量时间点：

基线、随访

测量方法：

通过门诊随访或电话随访，运用所有可用信息（包括患者及家属的自我报告、医院的病历记录、客观的检查证据等）确认是否发生过由冠心病、卒中、心力衰竭、肾脏事件组成的复合临床事件。

Measure time point of outcome：

Baseline, follow-up

Measure method：

Through outpatient follow-up or telephone follow-up, confirm the occurrence of composite clinical events consisting of coronary heart disease, stroke, heart failure, and renal events by utilizing all available information, including self-reports from patients and their families, hospital medical records, and objective examination evidence.

指标中文名：

高血压介导的靶器官损伤

指标类型：

次要指标

Outcome：

hypertension-mediated organ damage

Type：

Secondary indicator

测量时间点：

随访

测量方法：

重点关注高血压介导的心脏、肾脏及血管损害，测量方法包括心电图、心脏彩超、肾功能、尿白蛋白肌酐比、动脉超声

Measure time point of outcome：

follow-up

Measure method：

Focus on hypertension-mediated damage to the heart, kidneys, and blood vessels. Measurement methods include electrocardiogram, cardiac ultrasound, renal function tests, urine albumin-to-creatinine ratio, and arterial ultrasound.

指标中文名：

卒中

指标类型：

次要指标

Outcome：

Stroke

Type：

Secondary indicator

测量时间点：

随访

测量方法：

通过门诊复诊及电话对患者或患者家属进行随访，询问是否发生卒中事件。包括缺血性卒中、蛛网膜下腔出血、脑实质内出血、其他出血、其他类型或未知类型。

Measure time point of outcome：

follow-up

Measure method：

Through outpatient follow-up and telephone consultations, patients or their family members are surveyed to inquire about any occurrence of stroke events. This includes ischemic stroke, subarachnoid hemorrhage, intracerebral hemorrhage, other types of bleeding, or other types or unknown types.

指标中文名：

非致死性心梗

指标类型：

次要指标

Outcome：

Nonfatal myocardial infarction

Type：

Secondary indicator

测量时间点：

随访

测量方法：

通过门诊复诊及电话对患者或患者家属进行随访，询问是否发生非致死性心肌梗死事件。心肌梗死的诊断标准包括明确的心电图表现（即ST段抬高）、典型或非典型急性缺血的症状和心电图表现和异常心肌酶，或典型症状和异常心肌酶伴或不伴心电图表现。

Measure time point of outcome：

follow-up

Measure method：

Patients or their families were followed up through outpatient follow-up visits and telephone calls to inquire whether non-fatal myocardial infarction events occurred. The diagnostic criteria for myocardial infarction include clear electrocardiographic manifestations (i.e., ST segment elevation), typical or atypical symptoms and electrocardiographic manifestations of acute ischemia and abnormal myocardial enzymes, or typical symptoms and abnormal myocardial enzymes with or without electrocardiog

指标中文名：

冠心病

指标类型：

次要指标

Outcome：

Coronary Heart Disease

Type：

Secondary indicator

测量时间点：

随访

测量方法：

通过查阅既往门诊病历、门诊复诊及电话对患者或患者家属进行随访，询问是否诊断为冠心病。冠心病的诊断标准为经客观证据证实的冠状动脉狭窄≥50%。

Measure time point of outcome：

follow-up

Measure method：

By reviewing previous outpatient medical records, conducting follow-up visits, and contacting patients or their relatives via phone, we inquired whether a diagnosis of coronary heart disease had been made. The diagnostic criterion for coronary heart disease is a coronary artery stenosis confirmed by objective evidence of 50% or greater.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 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）：

无

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

None

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

否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）：

不分享原始数据

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

Do not share raw data

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：

电子采集和管理系统

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

Electronic Data Capture

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-12-25 09:07:41