Hypertension Longitudinal Data Platform in Tianjin

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06415071
• Other study ID #: HYLERP
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1172280
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hypertension first diagnosed between January 1, 2015 and December 31, 2021

• Aged 18 years or older

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• No intervention
Exposures of interest would be clearly defined according to a specific research question and identified from the database

Locations

Country	Name	City	State
China	The West China Hospital of Sichuan university	Chengdu	Sichuan

Sponsors (3)

Lead Sponsor	Collaborator
West China Hospital	Tianjin Health Care Big Data Ltd., Tianjin Health Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)