Hypertension Registry of "Hypertension Prevention and Control Initiative in China"

Hypertension Clinical Trial

Official title:

The National Hypertension Registry Study of the "Hypertension Prevention and Control Initiative in China" Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04289701
• Other study ID #: 2019-ZX20
• Status: Recruiting
• Start date: October 8, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2020
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: LUYUN FAN, MD
• Phone: 01088392165
• Email: fuwai_fanluyun[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Health Services for Systematic Hypertension Management
The systematic hypertension management health services from the "Hypertension prevention and control initiative in China" project. Main services are as follows: Healthcare provider training and patient education. Standardized guideline-based hypertension diagnosis, treatment and management recommendation. Patient-centered, pan-cycle continuous hypertension management via the organizing framework of NMAH and sharing digital platform. Periodical Patient follow-up via blood pressure monitor-sharing system and in collaboration with other basic local public health programs. Outcome and performance evaluation quarterly. Incentives for healthcare organizations and primary healthcare providers, and subsidies to patients. Certification for "Honorary Hypertension Centers" at county levels and establishment for hypertension clinics at primary care centers.

Locations

Country	Name	City	State
China	The second affiliated hospital of Baotou medical college	Baotou	Inner Mongolia
China	Beijing Shunyi District Hospital	Beijing	Beijing
China	Chinese Academy of Medical Sciences,Fuwai Hospital	Beijing	Beijing
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	First affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The First Affliated Hospital of Anhui Medical University	Hefei	Anhui
China	FuWai YunNan Cardiovascular Hospital	Kunming	Yunnan
China	The Second Affilated Hospital Of Nanchang University	Nanchang	Jiangxi
China	Teda International Cardiovascular Hospital	Tianjin	Tianjin
China	First Affiliated Hospital, Xian Jiaotong University	Xi'an	Shanxi
China	Yinchuan First People's Hospital	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Office BP Control: Office BP controlled to target (Systolic BP<140mmHg and Diastolic BP<90mmHg); Home BP Control: Home BP controlled to target (Systolic BP<135mmHg and Diastolic BP<85 mmHg)	at 3-month intervals over 24 months
Secondary	Change for Systolic Blood Pressure(SBP)	Change for SBP from baseline to follow-ups	at 3-month intervals over 24 months
Secondary	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	1 year
Secondary	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
Secondary	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