Clinical trial NCT06415071: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Longitudinal data platform
Electronic health records
Public health follow-up database
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Health Care Big Data Ltd.
name: Tianjin Health Commission
First posted: 2024-05-16
Enrollment: 1172280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence rate of major adverse cardiovascular events
timeFrame: From index diagnosis to the end of study date (Dec 31, 2021)
measure: Prevalence of composite adervese events
timeFrame: From index diagnosis to the end of study date (Dec 31, 2021)
measure: Mortality rate
timeFrame: From index diagnosis to the end of study date (Dec 31, 2021)
measure: Prescription patterns of antihypertensive medications
timeFrame: From index prescrition to the end of study date (Dec 31, 2021)
measure: Medical expenditures
timeFrame: through study completion, an average of 7 year (from Jan 2015 to Dec 31, 2021)
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: The West China Hospital of Sichuan university
state: Sichuan
Study officials:
affiliation: West China Second University Hospital
name: Xin Sun, Phd
role: STUDY_DIRECTOR
References: