Potential Associated Factors of Uncontrolled Hypertension

March 29, 2016 updated by: Guangdong Provincial People's Hospital

Initial Investigation on Potential Associated Factors of Uncontrolled Hypertension in Outpatient Department: A Prospective Registry Study

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Cardiovascular Institute,Guangdong General Hospital
        • Sub-Investigator:
          • Dan Zhou, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yingqing Feng, MD
        • Sub-Investigator:
          • Qi Zhong, MD
        • Sub-Investigator:
          • Xida Li, MD
        • Sub-Investigator:
          • Xueju Yu, MD
        • Sub-Investigator:
          • Huiming Yu, MD
        • Sub-Investigator:
          • Yujin Mo, MD
        • Sub-Investigator:
          • Ying Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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).

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertension controlled rate in participants after potential associated factors are corrected
Time Frame: Up to 1 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

March 30, 2016

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDREC 2015373H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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