跳至主要内容
临床试验/NCT03540992
NCT03540992Unknown不适用

Development of Diagnostic and Treatment Strategy for Resistant Hypertension

Yonsei University1 个研究点 分布在 1 个国家目标入组 780 人开始时间: 2018年2月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
780
试验地点
1
主要终点
Major adverse cardiac events

研究概览

简要总结

This study is a registry study to examine the clinical features, blood pressure control rate, and clinical prognosis of resistant hypertension in Koreans. This study will register patients with resistance hypertension in eight tertiary hospitals in Korea and follow up them for three years. The prognosis will be analysed according to etiologies, achieved blood pressure, and types of antihypertensive medication.

详细描述

This study will enroll hypertensive patients who are in treatment or those who are referred from primary clinic based on inclusion or exclusion criteria. Basic clinical information, compliance with antihypertensive medications, concomitant use of other medications will be investigated and all patients will perform 24-hr ambulatory blood pressure measurement. Screening for renal artery stenosis and primary aldosteronism will be conducted. Office blood pressure will be taken every 3-6 months. Home blood pressure measurement and 24-hr ambulatory blood pressure measurement will be performed every year. The primary outcome is the newly developed MACE during the follow-up period. The secondary outcomes are newly developed target organ damage (LVH confirmed by echocardiography or EKG, carotid femoral PWV≥ 12m/s, microalbuminuria (Urine albumin-creatinine ratio ≥30 mg/g)) and decline of renal function (doubling of serum creatinine, dialysis). The follow-up period is 3 years.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 20 years and older
  • Office SBP>130 mmHg or office DBP >90 mmHg with 3 antihypertensive medications of different classes
  • Treated hypertensive patients with 4 antihypertensive medications of difference classes including diuretics

排除标准

  • desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis)
  • women with pregnancy or on nursing
  • within the first three months after transplantation
  • acute renal allograft rejection
  • within six months after discharge from hospitalization for acute coronary syndrome (myocardial infarction, unstable angina) or acute stroke
  • systolic heart failure (LVEF ≤40%)

结局指标

主要结局

Major adverse cardiac events

时间窗: 3 years

Composite of cardiovascular death, myocardial infarction, stroke, admission for heart fails

次要结局

  • Target blood pressure achievement(3 years)
  • Progression of CKD(3 years)
  • Target organ damages(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Development of Diagnostic and Treatment Strategy for... | 临床试验