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

Recruiting

• Conditions: Hypertension
• Interventions: Other: Health Services for Systematic Hypertension Management

• Registration Number: NCT04289701
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief 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. 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 Timeline

• Study Start: 2019-10-08
• Status Verified: 2020-02
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-27
• Last Update Submitted: 2020-02-27
• Study First Posted: 2020-02-28
• Last Update Posted: 2020-02-28
• Primary Completion: 2022-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypertension Cohort	Health Services for Systematic Hypertension Management	Hypertension patients recruited in the "Hypertension Prevention and Control Initiative in China" project.

Primary Outcome Measures

Name	Time	Method
Change for Blood Pressure Control Rate	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)

Secondary Outcome Measures

Name	Time	Method
Change for Systolic Blood Pressure(SBP)	at 3-month intervals over 24 months	Change for SBP from baseline to follow-ups
Composite Outcome of Cardiovascular Events at 1-year follow-up	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
Composite Outcome of Cardiovascular Events at 2-year follow-up	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
Change for Hypertension Treatment Rate	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.

Trial Locations

Locations (11)

The Second Affilated Hospital Of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

FuWai YunNan Cardiovascular Hospital; 🇨🇳 Kunming, Yunnan, China

The second affiliated hospital of Baotou medical college; 🇨🇳 Baotou, Inner Mongolia, China

Chinese Academy of Medical Sciences，Fuwai Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Shunyi District Hospital; 🇨🇳 Beijing, Beijing, China

Yinchuan First People's Hospital; 🇨🇳 Yinchuan, Ningxia, China

First Affiliated Hospital, Xian Jiaotong University; 🇨🇳 Xi'an, Shanxi, China

The First Affliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

First affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Teda International Cardiovascular Hospital; 🇨🇳 Tianjin, Tianjin, China