Effects of Angiotensin II Receptor Blockers (ARB) and Angiotensin Converting Enzyme Inhibitors (ACEI) on Progression of Silent Brain Infarction and Cognitive Decline in Japanese Patients With Essential Hypertension in the Elderly
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Fatal and nonfatal stroke
研究概览
简要总结
The purpose of this study is to elucidate whether or not angiotensin II receptor blockers (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on development or progression of silent brain infarction and cognitive decline in Japanese patients with essential hypertension in the elderly.
详细描述
Hypertension plays a major role in the development of cardiovascular diseases. Treating hypertension has been associated with reduction in the risk of stroke and myocardial infarction. Angiotensin converting enzyme inhibitor (ACEI), ramipril, showed a 32 % in relative risk of reduction in the Heart Outcomes Prevention Evaluation (HOPE) trial. Angiotensin II receptor blocker (ARB), losartan, also showed a 25 % in relative risk of reduction in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE).
Elderly people, especially hypertensive patients, with silent brain infarction have an increased risk of stroke and cognitive decline. However, no reports are seen on comparison of the effects of ARBs and ACEIs on progression of silent brain infarction and cognitive decline in patients with essential hypertension in the elderly.
The researchers therefore longitudinally evaluate silent brain infarction using magnetic resonance imaging and cognitive decline by Mini-Mental State Examination twice at an interval of 2 years in patients with essential hypertension in the elderly who are received antihypertensive therapy by ARB or ACEI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with essential hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90, or treated with antihypertensive drugs)
- •Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging
排除标准
- •Secondary hypertension
- •Atrial fibrillation
- •History or signs of cerebral disorders other than cerebrovascular disease
- •Malignant tumor
- •Chronic renal failure
- •Severe congestive heart failure
- •Hyperkalemia
- •Stenosis of bilateral renal artery
研究组 & 干预措施
1
Angiotensin II Receptor Antagonists group
干预措施: Angiotensin II Receptor Antagonists (Drug)
2
Angiotensin-converting Enzyme Inhibitors group
干预措施: Angiotensin-converting Enzyme Inhibitors (Drug)
结局指标
主要结局
Fatal and nonfatal stroke
时间窗: two years
Progression of silent brain infarction or white matter lesion on magnetic resonance imaging
时间窗: two years
次要结局
- Fatal and nonfatal acute coronary syndrome(two years)
- Admission for heart failure(two years)
- All cause mortality(two years)
研究者
Yoshihiko Saito
Professor
Nara Medical University