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

• Conditions: Hypertension

• Registration Number: NCT04015843
• Lead Sponsor: China Cardiovascular Association

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-11
• Study Start: 2019-08-22
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25
• Primary Completion: 2020-08-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be compliance of blood pressure in hypertensive patients after 3 months of treatment in hospitals at different levels.	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of outpatients with abnormal blood lipid levels in hospitals at different levels	3 months	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
Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels	3 months	Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels
Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events	3 months	Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events
Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels	3 months	Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels
Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment	1 months	Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment

Trial Locations

Locations (1)

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China