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临床试验/JPRN-UMIN000002567
JPRN-UMIN000002567已完成未知

Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study - Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study

DAIICHI SANKYO COMPANY, LIMITED0 个研究点目标入组 20,000 人开始时间: 2009年9月30日最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
20,000

研究概览

简要总结

A prospective observational study of 21 591 outpatients with essential hypertension (mean age, 64.9 years; women, 50.6%) enrolled between 2009 and 2010 at clinics and hospitals in Japan. After a mean follow-up period of 2.02 years, cardiovascular events occurred in 280 patients (incidence, 6.46/1000 patient years). The risk for the primary end point was significantly higher in patients with on-treatment morning home blood pressure >145 to 155 mmHg (hazard ratio, 1.83; 95% confidence interval, 1.12-2.99) and >155 mmHg (hazard ratio, 5.03; 95% confidence interval, 3.05-8.31) than <125 mmHg, and with on-treatment clinic blood pressure >150 to 160 mmHg (hazard ratio, 1.69; 95% confidence interval, 1.10-2.60) and >160 mmHg (hazard ratio, 4.38; 95% confidence interval, 2.84-6.75) than <130 mmHg. Morning home blood pressure associated with minimum risk was 124 mmHg by spline regression analysis. Cardiovascular risk was increased in patients with morning home blood pressure >145 mmHg and clinic blood pressure <130 mmHg (hazard ratio, 2.47; 95% confidence interval, 1.20-5.08) compared to morning home blood pressure <125 mmHg and clinic blood pressure <130 mmHg. In conclusion, it is essential to control morning home blood pressure to <145 mmHg, even in patients with controlled clinic blood pressure.

研究设计

研究类型
Observational

入排标准

年龄范围
ot applicable 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • (1)Patients with prior myocardial infarction, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, and stroke of unknown type (however, patients with TIA are eligible for inclusion) within the previous 6 months. (2)Patients undergoing coronary intervention surgery such as percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), and the like and those who had been hospitalized due to heart failure within the previous 6 months. (3)Patients scheduled to undergo coronary intervention surgery such as PCI, CABG, or the like when OLM is started to administer. (4)Patients with persistent or sustained atrial fibrillation. (5)Patients with history of or concurrent cardiac diseases such as congenital heart diseases, rheumatic heart disease, and moderate-to-severe valvular heart disease. (6)Patients with unstable angina pectoris or severe arrhythmia. (7)Pregnant or possibly pregnant patients. (8)Patients deemed inadequate for long-term monitoring (e.g. those under treatment for severe hepatic or renal dysfunction (patients undergoing kidney dialysis are not eligible), malignant neoplasm, and the like) as determined by physician.

研究者

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