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

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

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

Study Overview

• Status: Unknown
• Conditions: Hypertension

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 Type: Observational
• Enrollment (Anticipated): 1800

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Asia Heart Hospital
      • Contact: Hu Daqing, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Initial diagnosis of primary hypertension

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: China Cardiovascular Association

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Anticipated): August 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: GUSU18006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No