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

NCT ID: NCT04289701

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-08

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension

Keywords

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Hypertension Blood Pressure Control

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypertension Cohort

Hypertension patients recruited in the "Hypertension Prevention and Control Initiative in China" project.

Health Services for Systematic Hypertension Management

Intervention Type OTHER

The systematic hypertension management health services from the "Hypertension prevention and control initiative in China" project. Main services are as follows:

1. Healthcare provider training and patient education.
2. Standardized guideline-based hypertension diagnosis, treatment and management recommendation.
3. Patient-centered, pan-cycle continuous hypertension management via the organizing framework of NMAH and sharing digital platform.
4. Periodical Patient follow-up via blood pressure monitor-sharing system and in collaboration with other basic local public health programs.
5. Outcome and performance evaluation quarterly.
6. Incentives for healthcare organizations and primary healthcare providers, and subsidies to patients.
7. Certification for "Honorary Hypertension Centers" at county levels and establishment for hypertension clinics at primary care centers.

Interventions

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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:

1. Healthcare provider training and patient education.
2. Standardized guideline-based hypertension diagnosis, treatment and management recommendation.
3. Patient-centered, pan-cycle continuous hypertension management via the organizing framework of NMAH and sharing digital platform.
4. Periodical Patient follow-up via blood pressure monitor-sharing system and in collaboration with other basic local public health programs.
5. Outcome and performance evaluation quarterly.
6. Incentives for healthcare organizations and primary healthcare providers, and subsidies to patients.
7. Certification for "Honorary Hypertension Centers" at county levels and establishment for hypertension clinics at primary care centers.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jun Cai

Director,Hypertension Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Cai, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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The First Affliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status NOT_YET_RECRUITING

Chinese Academy of Medical Sciences,Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Shunyi District Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

First affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status NOT_YET_RECRUITING

The second affiliated hospital of Baotou medical college

Baotou, Inner Mongolia, China

Site Status NOT_YET_RECRUITING

The Second Affilated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Site Status NOT_YET_RECRUITING

Yinchuan First People's Hospital

Yinchuan, Ningxia, China

Site Status NOT_YET_RECRUITING

First Affiliated Hospital, Xian Jiaotong University

Xi’an, Shanxi, China

Site Status NOT_YET_RECRUITING

Teda International Cardiovascular Hospital

Tianjin, Tianjin Municipality, China

Site Status NOT_YET_RECRUITING

FuWai YunNan Cardiovascular Hospital

Kunming, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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LUYUN FAN, MD

Role: CONTACT

Phone: 01088392165

Email: [email protected]

LU WANG

Role: CONTACT

Phone: 01088392165

Email: [email protected]

Other Identifiers

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2019-ZX20

Identifier Type: -

Identifier Source: org_study_id