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Clinical Trials/NCT06415071
NCT06415071
Completed
Not Applicable

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

West China Hospital1 site in 1 country1,172,280 target enrollmentJanuary 1, 2015
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
West China Hospital
Enrollment
1172280
Locations
1
Primary Endpoint
Prevalence of composite adervese events
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2015
End Date
December 31, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sun Xin

Professor and director of Chinese Evidence-based Medicine Center

West China Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Prevalence of composite adervese events

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

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.

Prescription patterns of antihypertensive medications

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

(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.

Medical expenditures

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

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.

Incidence rate of major adverse cardiovascular events

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

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.

Mortality rate

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

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.

Study Sites (1)

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