Potential Associated Factors of Uncontrolled Hypertension

Hypertension,Essential Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02723643
• Other study ID #: GDREC 2015373H
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2016
• Last updated: March 29, 2016
• Start date: January 2016

Study information

• Verified date: March 2016
• Source: Guangdong General Hospital
• Contact: Anping Cai, MD
• Phone: 8615989267312
• Email: caianping1983[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension,Essential

Locations

Country	Name	City	State
China	Guangdong Cardiovascular Institute,Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No