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临床试验/NCT04015843
NCT04015843Unknown不适用

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

China Cardiovascular Association1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2019年8月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,800
试验地点
1
主要终点
The primary endpoint will be compliance of blood pressure in hypertensive patients after 3 months of treatment in hospitals at different levels.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients meeting the following criteria will be included:
  • Age ≥18 years, male or female;
  • Agreement for blood pressure and lipid testing;
  • 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;
  • Willingness to participate in the study and signing of informed consent.

排除标准

  • Patients meeting the following criteria will be excluded:
  • Involvement in an interventional clinical research;
  • Pregnancy or lactation in women;
  • Complication with malignant tumors;
  • Diagnosis of non-primary hypertension by researchers;
  • Impaired cognitive ability;
  • Researchers believing that the patients have other conditions not suitable for the study.

结局指标

主要结局

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

时间窗: 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.

次要结局

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

研究者

发起方
China Cardiovascular Association
申办方类型
Other
责任方
Sponsor

研究点 (1)

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