NCT03708601

Brief Summary

The registry study aims to determine serial biomarkers to prognosis of Essential Hypertension

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 8, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2022

Completed
Last Updated

May 24, 2019

Status Verified

June 1, 2018

Enrollment Period

5.9 years

First QC Date

October 8, 2018

Last Update Submit

May 22, 2019

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (3)

  • Number of cardiovascular adverse events

    Number of cardiovascular adverse events including unstable angina, coronary revascularization, acute myocardial infarction, heart failure, atrial fibrillation. revascularization, myocardial infarction, heart failure

    These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.

  • Number of cerebrovascular adverse events

    Number of cerebrovascular adverse events including ischemic stroke and hemorrhagic stroke.

    These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.

  • Number of renal adverse events

    Number of renal adverse events including Double serum creatinine or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2 or dialysis required).

    These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.

Eligibility Criteria

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

The case group consists of patients who was diagnosed as Essential Hypertension; control group is general population without Essential Hypertension

You may qualify if:

  • Men or women of any racial background, 18 years of age and older, with systolic BP greater than or equal to160 mm Hg, and presence of three or more cardiovascular risk factors or disease.
  • The qualifying risk factors were male sex, age older than 50 years, verified diabetes mellitus, current smoking, high total cholesterol, left ventricular hypertrophy by electrocardiogram, proteinuria on dipstick and raised serum creatinine between 150 and 265 umol/L. The qualifying diseases were verified coronary disease, cerebrovascular disease or peripheral arterial occlusive disease, or left ventricular hypertrophy with strain pattern.

You may not qualify if:

  • Secondary hypertension, pregnancy, history of heart failure or left ventricular ejection fraction less than 40%, myocardial infarction within one month, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, cerebrovascular disease, severe liver disease, severe chronic renal failure (eGFR less than 30 mL/min/1.73 m2) in the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (1)

  • Yin W, Li F, Tan X, Wang H, Jiang W, Wang X, Li S, Zhang Y, Han Q, Wang Y, Du J. Plasma Ceramides and Cardiovascular Events in Hypertensive Patients at High Cardiovascular Risk. Am J Hypertens. 2021 Nov 20;34(11):1209-1216. doi: 10.1093/ajh/hpab105.

    PMID: 34232291DERIVED

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Jie Du, PhD

    The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases

    STUDY DIRECTOR

Central Study Contacts

Yuan Wang, PhD

CONTACT

86-010-64456721wangyuan980510@163.com

Xin Tan, PhD

CONTACT

86-010-64456721tanxin025@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 17, 2018

Study Start

September 8, 2016

Primary Completion

August 8, 2022

Study Completion

August 8, 2022

Last Updated

May 24, 2019

Record last verified: 2018-06

Locations

CN(1)