NCT01394770Unknown4 期
Cardiovascular Events in Hypertensive Hemodialysed Patients: Aliskiren Versus Amlodipine. A Randomized, Double-blind Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- composite end-point of: all-cause mortality; cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke
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 aliskiren, a direct renin inhibitor, compared with amlodipine, a calcium channel blocker, reduces mortality and cardiovascular events in these high-risk patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemodialysed patients
- •predialytic blood pressure greater or equal to 140/90 mmHg
排除标准
- •history of heart failure
- •history of ischemic heart disease
- •severe aortic stenosis
- •known allergy to aliskiren or amlodipine
- •severe disorders of liver function
研究组 & 干预措施
Aliskiren
Experimental
干预措施: Aliskiren (Drug)
Amlodipine
Active Comparator
干预措施: Aliskiren (Drug)
结局指标
主要结局
composite end-point of: all-cause mortality; cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke
时间窗: 30 months
次要结局
- composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation(30 months)
研究者
Gennaro Cice
MD
University of Campania "Luigi Vanvitelli"
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Hemodynamics in Chronic Hemodialysis Patients Undergoing Isolated Ultrafiltration Compared to Conventional HemodialysisEnd Stage Kidney DiseaseNCT05642156Medical University of Graz32
Unknown
4 期
RAAS Inhibitor Drugs in Dialysis PatientsEnd Stage Renal DiseaseHypertensionNCT01635387University of Campania "Luigi Vanvitelli"350
尚未招募
不适用
Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis UnitsChronic Kidney Disease 5DNCT06695611University of Manitoba60
已完成
不适用
Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk FactorsPulmonary HypertensionNCT03310229Assiut University80
已完成
不适用
Blood Pressure in Dialysis PatientsRenal Failure Chronic Requiring HemodialysisBlood PressureDialysisHypertensionNCT01421771University of New Mexico126