Clinical trial NCT04289701: Hypertension Registry of "Hypertension Prevention and Control Initiative in China"
Official title: The National Hypertension Registry Study of the "Hypertension Prevention and Control Initiative in China" Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: Hypertension
Blood Pressure Control
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 200000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. Residing in the local administrative area for at least 6 months.
3. Hypertension：defined as systolic blood pressure (SBP) ≥140 mmHg and/or /diastolic blood pressure (DBP) ≥90 mmHg and/or use of antihypertensive medication within two weeks.
4. Informed consent.

Exclusion Criteria:

1. patients under pregnancy or lactation.
2. patients with severe liver or renal diseases.
3. patients with history of malignant tumor.
4. patients with mental illness that impair their consent.

Primary outcomes:
measure: Change for Blood Pressure Control Rate
timeFrame: at 3-month intervals over 24 months
Secondary outcomes:
measure: Change for Systolic Blood Pressure(SBP)
timeFrame: at 3-month intervals over 24 months
measure: Composite Outcome of Cardiovascular Events at 1-year follow-up
timeFrame: 1 year
measure: Composite Outcome of Cardiovascular Events at 2-year follow-up
timeFrame: 2 years
measure: Change for Hypertension Treatment Rate
timeFrame: at 3-month intervals over 24 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences，Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Shunyi District Hospital
state: Beijing
city: Harbin
country: China
facility: First affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: The second affiliated hospital of Baotou medical college
state: Inner Mongolia
city: Nanchang
country: China
facility: The Second Affilated Hospital Of Nanchang University
state: Jiangxi
city: Yinchuan
country: China
facility: Yinchuan First People's Hospital
state: Ningxia
city: Xi'an
country: China
facility: First Affiliated Hospital, Xian Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Teda International Cardiovascular Hospital
state: Tianjin
city: Kunming
country: China
facility: FuWai YunNan Cardiovascular Hospital
state: Yunnan
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Jun Cai, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: