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

February 27, 2020 updated by: Jun Cai, Chinese Academy of Medical Sciences, Fuwai Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change for Blood Pressure Control Rate
Time Frame: at 3-month intervals over 24 months

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:

  1. Office BP Control: Office BP controlled to target (Systolic BP<140mmHg and Diastolic BP<90mmHg)
  2. 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change for Systolic Blood Pressure(SBP)
Time Frame: at 3-month intervals over 24 months
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
Time Frame: 1 year
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
Time Frame: 2 years
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
Time Frame: at 3-month intervals over 24 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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