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Completed

NCT Number: NCT06415071

Hypertension Longitudinal Data Platform in Tianjin

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The West China Hospital of Sichuan university

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Collaborators

  • Tianjin Health Care Big Data Ltd.
  • Tianjin Health Commission

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
May 16, 2024
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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