NCT04015843

Brief Summary

This is a multi-center, prospective cohort study that collects only diagnostic and therapeutic data in subjects but does not interfere with treatment.

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
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

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

First Submitted

Initial submission to the registry

July 3, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 22, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

November 25, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

July 3, 2019

Last Update Submit

November 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will be compliance of blood pressure in hypertensive patients after 3 months of treatment in hospitals at different levels.

    Blood pressure measurement: Blood pressure in both upper arms will be measured with a sphygmomanometer, with the patient in the sitting position. The mean value of three tests will be used for statistics. When left and right upper arms show different blood pressures, the higher value will be used for statistics.

    3 months

Secondary Outcomes (5)

  • Percentage of outpatients with abnormal blood lipid levels in hospitals at different levels

    3 months

  • Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels

    3 months

  • Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels

    3 months

  • Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events

    3 months

  • Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment

    1 months

Eligibility Criteria

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

Initial diagnosis of primary hypertension

You may qualify if:

  • Patients meeting the following criteria will be included:
  • Age ≥18 years, male or female;
  • Agreement for blood pressure and lipid testing;
  • Initial diagnosis of primary hypertension, with blood pressure conforming to the diagnostic criteria of the 2018 Guidelines for the Prevention and Treatment of Hypertension in China \[14\] (with no antihypertensive drugs, SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg after three tests performed on different days); or a history of primary hypertension but incompliant blood pressure;
  • Willingness to participate in the study and signing of informed consent.

You may not qualify if:

  • Patients meeting the following criteria will be excluded:
  • Involvement in an interventional clinical research;
  • Pregnancy or lactation in women;
  • Complication with malignant tumors;
  • Diagnosis of non-primary hypertension by researchers;
  • Impaired cognitive ability;
  • Researchers believing that the patients have other conditions not suitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • yong huo, master

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

wei ma, doctor

CONTACT

jie wang, doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 11, 2019

Study Start

August 22, 2019

Primary Completion

August 30, 2020

Study Completion

November 30, 2020

Last Updated

November 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations