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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Health Services for Systematic Hypertension Management

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.

• Study Type: Observational
• Enrollment (Anticipated): 200000

Contacts and Locations

• Study Contact: Name: LUYUN FAN, MD; Phone Number: 01088392165; Email: fuwai_fanluyun@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Not yet recruiting
      • The First Affliated Hospital Of Anhui Medical University
      • Principal Investigator: Birong Zhou, MD
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Chinese Academy of Medical Sciences，Fuwai Hospital
      • Principal Investigator: Jun Cai, MD
    • Beijing, Beijing, China, 101300
      • Recruiting
      • Beijing Shunyi District Hospital
      • Sub-Investigator: Hongwei Zhang, MD
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Recruiting
      • First Affiliated Hospital of Harbin Medical University
      • Principal Investigator: Xinhua Yin, MD
  • Hunan
    • Changsha, Hunan, China, 410013
      • Not yet recruiting
      • The Third Xiangya Hospital of Central South University
      • Principal Investigator: Hong Yuan, MD
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014030
      • Not yet recruiting
      • The Second Affiliated Hospital of Baotou Medical College
      • Principal Investigator: Gang Sun, MD
  • Jiangxi
    • Nanchang, Jiangxi, China, 330046
      • Not yet recruiting
      • The Second Affilated Hospital Of Nanchang University
  • Ningxia
    • Yinchuan, Ningxia, China, 750010
      • Not yet recruiting
      • Yinchuan First People's Hospital
      • Principal Investigator: Fang Chen, MD
  • Shanxi
    • Xi'an, Shanxi, China, 710061
      • Not yet recruiting
      • First Affiliated Hospital, Xian Jiaotong University
      • Principal Investigator: Gang Tian, MD
  • Tianjin
    • Tianjin, Tianjin, China, 300457
      • Not yet recruiting
      • Teda International Cardiovascular Hospital
      • Principal Investigator: Yuming Li, MD
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Recruiting
      • Fuwai Yunnan Cardiovascular Hospital
      • Principal Investigator: Zihong Guo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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 Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Hypertension; Blood Pressure Control
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2019-ZX20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No