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Potential Associated Factors of Uncontrolled Hypertension

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ClinicalTrials.gov Identifier: NCT02723643
Recruitment Status : Unknown
Verified March 2016 by Guangdong General Hospital.
Recruitment status was:  Recruiting
First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Guangdong General Hospital

Tracking Information
First Submitted Date March 18, 2016
First Posted Date March 30, 2016
Last Update Posted Date March 30, 2016
Study Start Date January 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2016)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Potential Associated Factors of Uncontrolled Hypertension
Official Title Initial Investigation on Potential Associated Factors of Uncontrolled Hypertension in Outpatient Department: A Prospective Registry Study
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Description:
Venous blood will be sampled for further DNA assessment after informed consent is obtained
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).
Condition Hypertension,Essential
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 29, 2016)
2000
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02723643
Other Study ID Numbers GDREC 2015373H
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Guangdong General Hospital
Study Sponsor Guangdong General Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Guangdong General Hospital
Verification Date March 2016