Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 2,600
- 试验地点
- 1
- 主要终点
- Combined cardiovascular events
研究概览
简要总结
The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs.
The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. The study subjects are 40-79 years old hypertensive patients. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (morning home BP <140 mmHg) or (2) strict control group (morning home BP <130 mmHg), and to (a) amlodipine group or (b) losartan group. Additional antihypertensive drugs can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. The participants will be followed up for 5 years.
详细描述
The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs.
The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. Inclusion criteria are 40-79 years old treated or untreated hypertensive patients without serious medical conditions. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (target morning home BP <140 mmHg) or (2) strict control group (morning home BP <130 mmHg), and to (a) amlodipine group (2.5-5 mg od) or (b) losartan group (25-50 mg od). Additional antihypertensive drugs (diuretics, beta-blockers and alpha-blockers) can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. Primary end point is combined cardiovascular events.The participants will be followed up for 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of hypertension
排除标准
- •Severe hypertension (treated with 3 or more antihypertensive drugs)
- •Unable to change antihypertensive drugs to a calcium antagonist or an angiotensin antagonist
- •Serious medical conditions
- •Women who may become to be pregnant
研究组 & 干预措施
1
target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)
干预措施: Amlodipine, Losartan (Drug)
2
antihypertensive drug (amlodipine vs losartan)
干预措施: Amlodipine, Losartan (Drug)
结局指标
主要结局
Combined cardiovascular events
时间窗: 5 years
次要结局
- Total mortality(5 years)
- Cardiovascular mortality(5 years)
- Myocardial infarction and new-onset angina(5 years)
- Stroke and transient ischemic attack(5 years)
- Renal failure(5 years)
- Aortic and peripheral artery diseases(5 years)
- Left ventricular mass and function(5 years)
- Urinary albumin and renal function(5 years)