A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- stroke
研究概览
简要总结
The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment, will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.
详细描述
Several recent clinical trials have demonstrated that angiotensin II receptor blockers (ARBs) have cardiovascular as well as renal protective effects. However, it is a problem that the number of Asian patients is very little in these trials. The researchers examine the treatment meaning by ARB about the prognosis of the patient who amalgamates either among high blood pressure, the ischemic heart disease, and congestive heart failures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 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, ischemic heart disease and congestive heart failure
排除标准
- •Pregnancy
- •Severe renal damage
- •Severe liver damage
- •Acute myocardial infarction
结局指标
主要结局
stroke
new or recurrent transient ischemic attack
new or recurrent acute myocardial infarction
new occurrence or exacerbation of heart failure
new occurrence or exacerbation angina pectoris
dissecting aneurysm of the aorta
lower limb arterial obstruction
transition to dialysis
doubling of plasma creatinine (Cr) levels
次要结局
- blood pressure and heart rate
- death from any cause
- left ventricular hypertrophy
- changes in ECG
- proteinuria
- B-type natriuretic peptide (BNP)
- heart failure symptoms
- heart failure syndrome (edema, rales on auscultation)