NCT03150888

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 3, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

3.4 years

First QC Date

May 4, 2017

Last Update Submit

January 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • 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

  • Total death

    From date of enrollment until date of death from all cause, assessed up to 3 year

  • 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

  • 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

Study Arms (2)

Hospital based hypertension cohort

Drug: Antihypertensive AgentsOther: Cardiovascular risk factors

Community based hypertension cohort

Drug: Antihypertensive AgentsOther: Cardiovascular risk factors

Interventions

Single or combination therapy with five type of antihypertensive agents, such as Ca channel blockers, ACE inhibitors, ARBs, diuretics, or beta-blockers.

Community based hypertension cohortHospital based hypertension cohort

Different level of cardiovascular risk factors associated with genetics, environments and lifestyles.

Community based hypertension cohortHospital based hypertension cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic, and community sample

You may qualify if:

  • Clinical diagnosis of hypertension
  • over 18 years old
  • ti sign the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Beijing Anzhen Hospital

Beijing, China

RECRUITING

Beijing Tiantan Hospital

Beijing, China

RECRUITING

Beijing Tsinghua Chang Gung Hospital

Beijing, China

RECRUITING

Southwest Hospital, China

Chongqing, China

RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, China

ACTIVE NOT RECRUITING

Ruijin Hospital

Shanghai, China

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, blood cell, urine and DNA

MeSH Terms

Conditions

Hypertension

Interventions

Antihypertensive AgentsHeart Disease Risk Factors

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesRisk FactorsRiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Jing Liu, MD,PhD

    Beijing Institute of Heart, Lung and Blood Vessel Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 12, 2017

Study Start

July 3, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations