NCT02723643

Brief Summary

The incidence and prevalence of hypertension is increasing while the controlled rate is extremely low in China. A substantial percentage of participants with uncontrolled hypertension are correctable if potential associated factors are identified and corrected. Therefore, it is clinically relevant to investigate and identify these potential associated factors of uncontrolled hypertension so as to increase controlled rate and reduce hypertension-associated health and economic burdens in the future. Investigators plan to conduct a prospective registry study in a single-center to initially investigate the potential associated factors of uncontrolled hypertension in cardiovascular outpatient department. Furthermore, investigators plan to evaluate the effects of potential associated factors correction on hypertension controlled rate and cardiovascular outcomes.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

March 18, 2016

Last Update Submit

March 29, 2016

Conditions

Hypertension,Essential

Keywords

HypertensionEssential hypertensionBlood pressureCardiovascular diseases

Outcome Measures

Primary Outcomes (1)

  • Hypertension controlled rate in participants after potential associated factors are corrected

    Participants with uncontrolled hypertension (SBP and/or DBP \>=140 and/or 90 mm Hg) treating with 3 or more anti-hypertensive drugs (not necessarily including diuretic) in outpatient department will under assessment of hypertension controlled rate 1 month later after initial investigation of potential associated factors. Based on these findings, investigators will give instructions to participants how to correct those potential associated factors and follow-up participants via telephone or outpatient visit 1 month later to assess whether these corrections could help increase hypertension controlled rate. Participants will be required to record home blood pressure measurements every day, and average home SBP and DBP will be calculated 1 month later. If average home SBP/DBP \< 135/85 mm Hg then participants will be considered as controlled-case, otherwise uncontrolled case.

    Up to 1 month

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatient populations with clinic systolic and/or diastolic blood pressure above 140 and/or 90 mm Hg treating with 3 different classes of anti-hypertensive drugs (not necessarily including diuretic).

You may qualify if:

  • Clinic systolic and/or diastolic blood pressure above 140 and/or 90 mm Hg treating with 3 different classes of anti-hypertensive drugs (not necessarily including diuretic).

You may not qualify if:

  • Known secondary hypertension,
  • Pregnant women,
  • Chronic kidney disease (CKD) 3 or higher,
  • Has a history of connective tissue diseases,
  • Has a history of any type of cancer,
  • Cognitive disorder which could not finish home blood pressure monitoring,
  • Has a history of coronary heart disease,ischemic stroke,transient ischemic attack or heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Cardiovascular Institute,Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood will be sampled for further DNA assessment after informed consent is obtained

MeSH Terms

Conditions

Essential HypertensionHypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Central Study Contacts

Anping Cai, MD

CONTACT

8615989267312caianping1983@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 30, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

CN(1)