- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04289701
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: LUYUN FAN, MD
- Phone Number: 01088392165
- Email: fuwai_fanluyun@163.com
Study Locations
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Anhui
-
Hefei, Anhui, China, 230022
- Not yet recruiting
- The First Affliated Hospital Of Anhui Medical University
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Principal Investigator:
- Birong Zhou, MD
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Recruiting
- Chinese Academy of Medical Sciences,Fuwai Hospital
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Principal Investigator:
- Jun Cai, MD
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Beijing, Beijing, China, 101300
- Recruiting
- Beijing Shunyi District Hospital
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Sub-Investigator:
- Hongwei Zhang, MD
-
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Heilongjiang
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Harbin, Heilongjiang, China, 150001
- Recruiting
- First Affiliated Hospital of Harbin Medical University
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Principal Investigator:
- Xinhua Yin, MD
-
-
Hunan
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Changsha, Hunan, China, 410013
- Not yet recruiting
- The Third Xiangya Hospital of Central South University
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Principal Investigator:
- Hong Yuan, MD
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-
Inner Mongolia
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Baotou, Inner Mongolia, China, 014030
- Not yet recruiting
- The Second Affiliated Hospital of Baotou Medical College
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Principal Investigator:
- Gang Sun, MD
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Jiangxi
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Nanchang, Jiangxi, China, 330046
- Not yet recruiting
- The Second Affilated Hospital Of Nanchang University
-
-
Ningxia
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Yinchuan, Ningxia, China, 750010
- Not yet recruiting
- Yinchuan First People's Hospital
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Principal Investigator:
- Fang Chen, MD
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Shanxi
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Xi'an, Shanxi, China, 710061
- Not yet recruiting
- First Affiliated Hospital, Xian Jiaotong University
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Principal Investigator:
- Gang Tian, MD
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Tianjin
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Tianjin, Tianjin, China, 300457
- Not yet recruiting
- TEDA International Cardiovascular Hospital
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Principal Investigator:
- Yuming Li, MD
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Yunnan
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Kunming, Yunnan, China, 650032
- Recruiting
- Fuwai Yunnan Cardiovascular Hospital
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Principal Investigator:
- Zihong Guo, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hypertension Cohort
Hypertension patients recruited in the "Hypertension Prevention and Control Initiative in China" project.
|
The systematic hypertension management health services from the "Hypertension prevention and control initiative in China" project. Main services are as follows:
|
What is the study measuring?
Primary Outcome Measures
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:
|
at 3-month intervals over 24 months
|
Secondary Outcome Measures
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-ZX20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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