Compliance of Blood Pressure and Lipid in Hypertensive Patients Under the Management of Hospitals at Different Levels

Hypertension Clinical Trial

Official title:

Compliance of Blood Pressure and Lipid in Hypertensive Patients Under the Management of Hospitals at Different Levels: a Real-world Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04015843
• Other study ID #: GUSU18006
• Status: Recruiting
• Start date: August 22, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2019
• Source: China Cardiovascular Association
• Contact: wei ma, doctor
• Phone: 13681050902
• Email: kmmawei[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multi-center, prospective cohort study that collects only diagnostic and therapeutic data in subjects but does not interfere with treatment.

Description:

The study aims to assess blood pressure and lipid levels, the use of lipid-lowering and antihypertensive drugs, and treatment compliance and adverse events in hypertensive outpatients of 30 hospitals of different levels, following them up for 1 and 3 months after treatment, respectively. The study would reveal the compliance of blood pressure and lipid levels in hypertensive patients under management of hospitals at different levels, and analyze factors affecting blood pressure or lipid levels associated with treatment compliance. Therefore, the study would provide clinical data from the real world for future prevention and control of CVD in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: November 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients meeting the following criteria will be included:

1. Age =18 years, male or female;

2. Agreement for blood pressure and lipid testing;

3. Initial diagnosis of primary hypertension, with blood pressure conforming to the diagnostic criteria of the 2018 Guidelines for the Prevention and Treatment of Hypertension in China [14] (with no antihypertensive drugs, SBP = 140 mmHg and/or DBP = 90 mmHg after three tests performed on different days); or a history of primary hypertension but incompliant blood pressure;

4. Willingness to participate in the study and signing of informed consent.

Exclusion Criteria:

• Patients meeting the following criteria will be excluded:

1. Involvement in an interventional clinical research;

2. Pregnancy or lactation in women;

3. Complication with malignant tumors;

4. Diagnosis of non-primary hypertension by researchers;

5. Impaired cognitive ability;

6. Researchers believing that the patients have other conditions not suitable for the study.

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
China	Wuhan Asia Heart Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
China Cardiovascular Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be compliance of blood pressure in hypertensive patients after 3 months of treatment in hospitals at different levels.	Blood pressure measurement: Blood pressure in both upper arms will be measured with a sphygmomanometer, with the patient in the sitting position. The mean value of three tests will be used for statistics. When left and right upper arms show different blood pressures, the higher value will be used for statistics.	3 months
Secondary	Percentage of outpatients with abnormal blood lipid levels in hospitals at different levels	On a CardioChek dry-type biochemical analyzer, the levels of total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) in fingertip blood samples will be measured after 12-h fasting	3 months
Secondary	Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels	Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels	3 months
Secondary	Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels	Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels	3 months
Secondary	Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events	Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events	3 months
Secondary	Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment	Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment	1 months