Hypertension Longitudinal Data Platform in Tianjin

NCT06415071 | Completed DMC

• 1 other identifier: HYLERP
• Study Type: observational
• Target: 1,172,280
• Locations: 1 country
• Sites: 1

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

Hypertension

Keywords

Longitudinal data platform; Electronic health records; Public health follow-up database

Outcome Measures

Primary Outcomes (5)

• Incidence rate of major adverse cardiovascular events

  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.

  From index diagnosis to the end of study date (Dec 31, 2021)

• Prevalence of composite adervese events

  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.

  From index diagnosis to the end of study date (Dec 31, 2021)

• Mortality rate

  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.

  From index diagnosis to the end of study date (Dec 31, 2021)

• Prescription patterns of antihypertensive medications

  (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.

  From index prescrition to the end of study date (Dec 31, 2021)

• Medical expenditures

  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.

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

Study Arms (1)

Patients diagnosed with hypertension

Other: No intervention

Interventions

No intervention OTHER

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

Patients diagnosed with hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• West China Hospital: lead
• Tianjin Health Care Big Data Ltd.: collaborator
• Tianjin Health Commission: collaborator

Study Sites (1)

The West China Hospital of Sichuan university

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xin Sun, Phd

  West China Second University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and director of Chinese Evidence-based Medicine Center

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 16, 2024
• Study Start: January 1, 2015
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)