HypertensionNCT04289701
Hypertension Registry of "Hypertension Prevention and Control Initiative in China"
An observational study of Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 11 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Health Services for Systematic Hypertension Management
- How many people
- 200,000 participants
- Where
- 11 sitesChina
- Study dates
- 8 Oct 2019to 30 Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years.
- Residing in the local administrative area for at least 6 months.
- 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.
- Informed consent.
Who cannot join
- patients under pregnancy or lactation.
- patients with severe liver or renal diseases.
- patients with history of malignant tumor.
- patients with mental illness that impair their consent.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 11 recruiting
- Not yet recruiting
The second affiliated hospital of Baotou medical college
Baotou, Inner Mongolia, 014030
Gang Sun, MD
- Recruiting
Chinese Academy of Medical Sciences，Fuwai Hospital
Beijing, Beijing Municipality, 100037
Jun Cai, MD
- Recruiting
Beijing Shunyi District Hospital
Beijing, Beijing Municipality, 101300
Hongwei Zhang, MD
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Hong Yuan, MD
- Recruiting
First affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Xinhua Yin, MD
- Not yet recruiting
The First Affliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Birong Zhou, MD
- Recruiting
FuWai YunNan Cardiovascular Hospital
Kunming, Yunnan, 650032
Zihong Guo, MD
- Not yet recruiting
The Second Affilated Hospital Of Nanchang University
Nanchang, Jiangxi, 330046
Ping Li, MD
- Not yet recruiting
Teda International Cardiovascular Hospital
Tianjin, Tianjin Municipality, 300457
Yuming Li, MD
- Not yet recruiting
First Affiliated Hospital, Xian Jiaotong University
Xi’an, Shanxi, 710061
Gang Tian, MD
- Not yet recruiting
Yinchuan First People's Hospital
Yinchuan, Ningxia, 750010
Fang Chen, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Health Services for Systematic Hypertension Management
- Keywords
- Hypertension, Blood Pressure Control
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Services for Systematic Hypertension ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypertension Cohort | Hypertension patients recruited in the "Hypertension Prevention and Control Initiative in China" project. Receives: Other: Health Services for Systematic Hypertension Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 3-month intervals over 24 months
Secondary outcomes (4)
Change for Systolic Blood Pressure(SBP)
Change for SBP from baseline to follow-ups
Measured: 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
Measured: 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
Measured: 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.
Measured: at 3-month intervals over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start8 Oct 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Cai, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Jun Cai, MD,PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289701
- Sponsor's protocol ID
- 2019-ZX20
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Hypertension Registry Study of the "Hypertension Prevention and Control Initiative in China" Project
- ClinicalTrials.gov ID
- NCT04289701
- Acronym / sponsor ID
- 2019-ZX20
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood Pressure Control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertension Cohort | – | Other: Health Services for Systematic Hypertension ManagementHypertension patients recruited in the "Hypertension Prevention and Control Initiative in China" project. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Residing in the local administrative area for at least 6 months.
- 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.
- Informed consent.
Key exclusion criteria (4 listed)
- patients under pregnancy or lactation.
- patients with severe liver or renal diseases.
- patients with history of malignant tumor.
- patients with mental illness that impair their consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Services for Systematic Hypertension ManagementThe 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. | Other | Hypertension Cohort |
Primary outcome
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)
4 secondary outcomes
Change for Systolic Blood Pressure(SBP)
Time frame: at 3-month intervals over 24 months
Composite Outcome of Cardiovascular Events at 1-year follow-up
Time frame: 1 year
Composite Outcome of Cardiovascular Events at 2-year follow-up
Time frame: 2 years
Change for Hypertension Treatment Rate
Time frame: at 3-month intervals over 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Cai, MD,PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LUYUN FAN, MD (01088392165, fuwai_fanluyun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change for Blood Pressure Control Rate (time frame: at 3-month intervals over 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.