NCT01635387Unknown4 期
Upstream Use of Aliskiren in Hypertensive Haemodialysis Patients: Effects on Cardiovascular Outcomes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 350
- 主要终点
- time to first clinical event (among mortality from any cause, cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke, new-onset heart failure, new-onset atrial fibrillation)
研究概览
简要总结
Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study was undertaken to ascertain whether the upstream of aliskirne, a direct renin inhibitor improves mortality and cardiovascular outcomes in these high-risk population.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic kidney disease stage 5
- •undergoing maintenance haemodialysis for a minimum of 3 months
- •existing arterial hypertension or
- •history of arterial hypertension or
- •resting blood pressure ≥140/90 mmHg or
- •antihypertensive medication
- •man and female
- •18 years and older.
排除标准
- •recent myocardial infarction (less than 3 months)
- •atrial fibrillation/atrial flutter
- •hypotension with systolic blood pressure of <90 mmHg
- •high-grade aortic stenosis
- •left ventricular ejection fration <50%
- •known allergy to aliskiren
- •severe disorders of liver function
研究组 & 干预措施
Aliskiren
Experimental
干预措施: aliskiren (Drug)
Placebo
Placebo Comparator
干预措施: aliskiren (Drug)
结局指标
主要结局
time to first clinical event (among mortality from any cause, cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke, new-onset heart failure, new-onset atrial fibrillation)
时间窗: 30 months
次要结局
未报告次要终点
研究者
Gennaro Cice
MD
University of Campania "Luigi Vanvitelli"
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