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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

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.

Condition or disease
Hypertension,Essential

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Initial Investigation on Potential Associated Factors of Uncontrolled Hypertension in Outpatient Department: A Prospective Registry Study
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Venous blood will be sampled for further DNA assessment after informed consent is obtained


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723643


Contacts
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Contact: Anping Cai, MD 8615989267312 caianping1983@hotmail.com

Locations
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China, Guangdong
Guangdong Cardiovascular Institute,Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yingling Zhou, MD    86-20-83827812-10528    zylgdh123@sina.com   
Contact: Anping Cai, MD    8615989267312    caianping1983@hotmail.com   
Principal Investigator: Yingqing Feng, MD         
Sub-Investigator: Qi Zhong, MD         
Sub-Investigator: Xida Li, MD         
Sub-Investigator: Dan Zhou, MD         
Sub-Investigator: Xueju Yu, MD         
Sub-Investigator: Huiming Yu, MD         
Sub-Investigator: Yujin Mo, MD         
Sub-Investigator: Ying Zhang, MD         
Sponsors and Collaborators
Guangdong General Hospital

Additional Information:

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Responsible Party: Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT02723643     History of Changes
Other Study ID Numbers: GDREC 2015373H
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016

Keywords provided by Guangdong General Hospital:
Hypertension
Essential hypertension
Blood pressure
Cardiovascular diseases

Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases