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Hypertension is the leading preventable risk factor of cardiovascular disease globally and in China. Unparalleled to remarkable increase of hypertension burden in China, blood pressure(BP) control is inadequate. A political public health project, "Hypertension Prevention and Control Initiative in China(Chronic Disease Demonstration District Construction)", was initiated in October 2019 for explore a feasible and reproducible archetype for hypertension management and to improve the registration, management, treatment and control rates of hypertension in China. The project is designed to consecutively implement health service strategies in 40 pilot counties covering 31 provinces and around 200,000 hypertension patients in mainland China, via the National Medical Alliance for Hypertension(NMAH). The Hypertension Registry study aims to registry, follow up and observe the clinical features, treatment, blood pressure control and outcomes of all hypertension patients managed in the "Hypertension Prevention and Control Initiative in China" project.
Objective: The study aims to investigate the clinical features, treatment, blood pressure control and outcomes of hypertension patients managed in the "Hypertension Prevention and Control Initiative in China" project.
Study Type: A national, multicenter, observational, prospective cohort study.
Study Design: The cardinal contents of this registry study are as follows:
Introduce the Digital Information System and train in completing case report forms.
Collect sociodemographic information, lifestyle behaviors, self-reported personal medical history, BP, anthropometric measurements, medication at registration, laboratory investigations of hypertension patients managed in the "Hypertension Prevention and Control Initiative in China" project. Build a baseline database of hypertension patients.
Gather the follow up information including general, clinical, therapeutic, prognostic data of all recruits at 3-month intervals over 2 years and build up the follow-up database.
Data management, quality control and statistic analysis: Digital Information Platform for data capture, document and cloud computing has been built and the investigators will manage and analyze data in align with key indicators. The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality.
Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before patient enrollment are required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertension Cohort | Hypertension patients recruited in the "Hypertension Prevention and Control Initiative in China" project. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Services for Systematic Hypertension Management | Other | The systematic hypertension management health services from the "Hypertension prevention and control initiative in China" project. Main services are as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change for Blood Pressure Control Rate | Change for blood pressure(BP) control rate (number of patients under BP control divided by number of patients registered) from baseline to follow-ups. BP control is defined as follows:
| at 3-month intervals over 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change for Systolic Blood Pressure(SBP) | Change for SBP from baseline to follow-ups | at 3-month intervals over 24 months |
| Composite Outcome of Cardiovascular Events at 1-year follow-up | A composite of first occurrence of myocardial infarction, stroke (ischemic or hemorrhagic), hospitalization for unstable angina or acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death from cardiovascular causes |
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Inclusion Criteria:
Exclusion Criteria:
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The study recruits patients managed in the "Hypertension Prevention and Control Initiative in China" project. Eligible criteria for the registry study are equal to the inclusion and exclusion criteria for the project. All adult hypertension residents are eligible except for patients cannot be managed at local primary care centers and needing to be transferred for specialist management or residence management.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LUYUN FAN, MD | Contact | 01088392165 | fuwai_fanluyun@163.com | |
| LU WANG | Contact | 01088392165 | wanglu@fuwai.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Cai, MD,PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affliated Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | 230022 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006296 | Health Services |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
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|
| 1 year |
| Composite Outcome of Cardiovascular Events at 2-year follow-up | A composite of first occurrence of myocardial infarction, stroke (ischemic or hemorrhagic), hospitalization for unstable angina or acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death from cardiovascular causes | 2 years |
| Change for Hypertension Treatment Rate | Change for Hypertension Treatment Rate from baseline to follow-ups. Hypertension treatment rate is defined as the number of patients under current antihypertensive medication therapy divided by the number of patients registered. | at 3-month intervals over 24 months |
| Chinese Academy of Medical Sciences,Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
|
| Beijing Shunyi District Hospital | Recruiting | Beijing | Beijing Municipality | 101300 | China |
|
| First affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150001 | China |
|
| The Third Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410013 | China |
|
| The second affiliated hospital of Baotou medical college | Not yet recruiting | Baotou | Inner Mongolia | 014030 | China |
|
| The Second Affilated Hospital Of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330046 | China |
|
| Yinchuan First People's Hospital | Not yet recruiting | Yinchuan | Ningxia | 750010 | China |
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| First Affiliated Hospital, Xian Jiaotong University | Not yet recruiting | Xi’an | Shanxi | 710061 | China |
|
| Teda International Cardiovascular Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300457 | China |
|
| FuWai YunNan Cardiovascular Hospital | Recruiting | Kunming | Yunnan | 650032 | China |
|