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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03150888
Other study ID # 2016YFC0900902
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 3, 2017
Est. completion date December 2020

Study information

Verified date January 2020
Source Beijing Institute of Heart, Lung and Blood Vessel Diseases
Contact Yue Qi, PhD
Phone +861064456324
Email qiyue_bjcn@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to construct hypertension specialized cohort using uniform standards and specifications. This study timely collected multi-dimensional clinical information through electronic medical records, mobile health, data integration, informatics and computer modern techniques, linking self-reported data and big data platforms from different sources to timely obtain the incidence and mortality data, and integrating hypertension cohort samples and the associated clinical records systematically, in order to build a 30-thousand hypertension specialized cohort with fine phenotypic data and blood/urine samples, thus far to provide support for the development of precise medicine research and related industries.


Recruitment information / eligibility

Status Recruiting
Enrollment 30000
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of hypertension

- over 18 years old

- ti sign the informed consent

Exclusion Criteria:

- with life-threatening severe disease, such as severe tumor or AIDs

- pregnancy or lactating women,or plan to pregnant within half a year,

- with severe mental disorders

- participating in clinical trials

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Antihypertensive Agents
Single or combination therapy with five type of antihypertensive agents, such as Ca channel blockers, ACE inhibitors, ARBs, diuretics, or beta-blockers.
Other:
Cardiovascular risk factors
Different level of cardiovascular risk factors associated with genetics, environments and lifestyles.

Locations

Country Name City State
China Beijing Anzhen Hospital Beijing
China Beijing Tiantan Hospital Beijing
China Beijing Tsinghua Chang Gung Hospital Beijing
China Southwest Hospital, China Chongqing
China Nanfang Hospital of Southern Medical University Guangzhou
China Ruijin Hospital Shanghai

Sponsors (6)

Lead Sponsor Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases Beijing Tiantan Hospital, Beijing Tsinghua Chang Gung Hospital, Nanfang Hospital of Southern Medical University, Ruijin Hospital, Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite end point of major cardiovascular and cerebrovascular events Composite end point of major cardiovascular and cerebrovascular events From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 year
Secondary New-onset of cardiovascular events New-onset of cardiovascular events From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 year
Secondary New-onset of stroke New-onset of stroke From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 year
Secondary Total death Total death From date of enrollment until date of death from all cause, assessed up to 3 year
Secondary Major bleeding Major bleeding From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 year
Secondary Atrial fibrillation Atrial fibrillation From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 year
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