A Multi-center, Open, Longitudinal, Observational Study to Assess the Treatment Trend and the Proportion of Target BP Attainment in Patients Whose Antihypertensive Regimens Are Changed to ARB-based Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,542
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg)
研究概览
简要总结
The recent hypertension clinical practice guidelines published by American College of Cardiology (ACC) and American Heart Association (AHA) reduced the target BP to 130/80 mmHg, indicating the needs for more aggressive efforts in hypertension treatment. However, studies in Koreans must be preceded before applying such new overseas guidelines; thus, this study has been designed to establish clinical materials reflecting treatment setting in Korea. In this study, patients with uncontrolled hypertension whose antihypertensive regimens are changed to ARB-based therapy (ARB monotherapy or ARB-containing combination therapy) will be followed to assess the treatment trend, treatment effect, and risk of cardiovascular disease.
详细描述
This study will be performed in patients with blood pressure (BP) uncontrolled by existing antihypertensive drugs (including ARB) among hypertensive patients visiting outpatient clinic of medical institutions in Korea. The study enrollment number will be assigned to the subjects who provide a written consent to the use of personal information and meet the inclusion/exclusion criteria. Follow-up will be conducted for 12 weeks in total and prespecified study related data will be collected in the case report form.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided written consent to the use of personal information after receiving the explanation of the objective, methodology, etc. of this clinical study
- •Male or female adults ≥ 19 years who are diagnosed with essential hypertension
- •Receiving outpatient treatment at the time of study enrollment
- •Patients with hypertension uncontrolled by existing antihypertensive drugs (including ARB) whose antihypertensive regimens decided and scheduled to be changed to ARB monotherapy or ARB-containing combination therapy (the result of the arm with a higher mean BP [systolic BP preferred] when measured twice with at least a 2-minute interval in both arms at the medical office on the study enrollment date, will become the reference)
- •Definition of uncontrolled hypertension: Target BP (SBP <140 mmHg and DBP <90 mmHg) not achieved even after the treatment using the existing antihypertensive drugs for 4 weeks or longer
排除标准
- •Patients who were hospitalized or are scheduled to be hospitalized 4 weeks before or after the study enrollment date
- •Patients with suspected or confirmed secondary hypertension
- •Pregnant or breast-feeding women
- •Patients who received investigational product within 12 weeks or are scheduled to participate in another clinical study while participating in this study
- •Patients who are determined inappropriate for participating in the study by investigators for other reasons
结局指标
主要结局
Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg)
时间窗: Week 12 after the treatment regimen change
Percentage of patients who attain the target blood pressure (BP) (\<140(SBP)/90(DBP) mmHg) at Week 12 after the treatment regimen change
次要结局
- Percentage of Patients With Controlled BP According to 2018 KSH Guideline(Week 12 after the treatment regimen change)
- Percentage of Patients With Controlled BP According to 2017 ACC/AHA Guideline(Week 12 after the treatment regimen change)
- Prcentage of Patients With Controlled BP According to Investigator's Target BP(Week 12 after the treatment regimen change)