## Protocol Section
### Identification Module
**NCT ID:** NCT06415071

**Brief Title:** Hypertension Longitudinal Data Platform in Tianjin

**Official Title:** Hypertension Longitudinal Data Platform Linked Electronic Health Records and Public Health Follow-up Database (HYLERP) in Tianjin, China

#### Organization Study ID Info
**ID:** HYLERP
#### Organization
**Class:** OTHER
**Full Name:** West China Hospital
### Status Module
#### Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2015-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Tianjin Health Care Big Data Ltd.

**Class:** UNKNOWN

**Name:** Tianjin Health Commission

#### Lead Sponsor

**Class:** OTHER

**Name:** West China Hospital

#### Responsible Party

**Investigator Affiliation:** West China Hospital

**Investigator Full Name:** Sun Xin

**Investigator Title:** Professor and director of Chinese Evidence-based Medicine Center

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Hypertension is one of the leading causes of death globally, and ranks among the top four risk factors for mortality and DALYs in China. However, large-scale population based longitudinal research data source for hypertension is lacking in China. Thus, we aimed to establish the first and most extensive hypertension database in China using healthcare data from the Tianjin city. This hypertension longitudinal data platformlinked electronic medical records (EMR) system 35 stores healthcare data of 1.17 million hypertension patients, from 43 tertiary hospitals and 39 secondary hospitals, along with a public health follow-up management system. Data on demographics, diagnosis, drug prescription, laboratory test, physical examination, and cost information were collected, the median follow-up time was 4.3 \[ interquartile range (IQR): 2.7-5.8\] years, and the median number of outpatient visits was 32 (IQR: 15-64) per patient. This database can address research needs including, drug utilization pattern analysis, policy implementation evaluation, digital medical device development, and other real world evidence studies. These researches would provide robust evidence to assist improving patient health outcomes and healthcare system decision-making.

### Conditions Module

**Conditions:**

- Hypertension

**Keywords:**

- Longitudinal data platform

- Electronic health records

- Public health follow-up database

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1172280

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: No intervention

**Label:** Patients diagnosed with hypertension

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients diagnosed with hypertension

**Description:** Exposures of interest would be clearly defined according to a specific research question and identified from the database

**Name:** No intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The first occurence of stroke, acute myocardial infarcation and heart failure after index diagnosis. Cardiovasuclar events were determned from the first ICD-10 diagnosis code recorded in the database.

**Measure:** Incidence rate of major adverse cardiovascular events

**Time Frame:** From index diagnosis to the end of study date (Dec 31, 2021)

**Description:** Counts of a composite adervese events after diagnosis including cardiac arrhythmia, gout, hyperkalaemia, hypocalaemia, hypotension, angioedema, fall, syncope, acute kidney injury and fracture. All ICD-10 diagnosis codes of adervese events among patients incurred after the index diagnosis were included to calculated the prevalence of adervese events.

**Measure:** Prevalence of composite adervese events

**Time Frame:** From index diagnosis to the end of study date (Dec 31, 2021)

**Description:** The mortality records on patients were linked to the national mortality register information system, all-cause mortality and cardiovascular mortality were idenitified through death reaseon recoded in the mortality information system.

**Measure:** Mortality rate

**Time Frame:** From index diagnosis to the end of study date (Dec 31, 2021)

**Description:** (1) Prescribing rate of different antihypertensive drug classes; (2) Substiution of generic drugs; (3) Number of drug therapy; (4) Different combination therapies; (4) Index prescription patterns and prevalent prescription patterns.

**Measure:** Prescription patterns of antihypertensive medications

**Time Frame:** From index prescrition to the end of study date (Dec 31, 2021)

**Description:** Medical expenditures per outpatient visit or inpatient admission would be calculated including total expenditures, drug expenditures and non-drug related expenditures for patients undergoing treatment of hypertension, dyslipidemia, diabetes and chronic ischemic heart diesease. All medical expenditures statistcis were based on the cost information recorded in the electronic medical records database.

**Measure:** Medical expenditures

**Time Frame:** through study completion, an average of 7 year (from Jan 2015 to Dec 31, 2021)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Hypertension first diagnosed between January 1, 2015 and December 31, 2021
* Aged 18 years or older

Exclusion Criteria:

* None

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Our study population consisted of 1,172,280 patients aged 18 years or older with hypertension diagnosed between January 1, 2015 and December 31, 2021 in database. Hypertension was defined as having at least two outpatient diagnoses or one hospital discharge diagnosis of hypertension.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chengdu

**Country:** China

**Facility:** The West China Hospital of Sichuan university

**State:** Sichuan

**Zip:** 610041

#### Overall Officials

**Official 1:**

**Affiliation:** West China Second University Hospital

**Name:** Xin Sun, Phd

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** According to the policy of Tianjin Health Commission, research institutions could apply for data access by submitting a formal study protocol, subjetced to approved by the Tianjin Health Care Big Data Ltd. and the Chinese Evidence -based Medicine Center. Ethical review and research registration are mandatory for all studies.

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006973

- Term: Hypertension

### Misc Info Module

- Version Holder: 2024-05-31
