Study of Triple Blockade of the Renin Angiotensin Aldosterone System (RAAS) in Diabetic (Type 1&2) Proteinuric Patients With (ACE-, ARB, DRI)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Reduction in albuminuria/proteinuria
研究概览
简要总结
Study Hypothesis:
Reduction in albuminuria has been shown to decrease progression of diabetic
nephropathy. In diabetic nephropathy patients treated with maximal
antihypertensive doses with dual RAAS blockade (total daily dose valsartan 320
mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg), persistent
albuminuria reflects further additional RAAS activation. Microvascular renal
disease due to increased RAAS activation may be more effectively treated with
triple blockade by the addition of a direct renin inhibitor (DRI) Aliskiren.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Macroalbuminuria > 300mg/g
- •Microalbuminuria 30-300mg/g
- •Stable on max dose of an ACE-I or ARB (Can also be titrated to max dosage of ACE-I and ARB and stable on those doses for at least 2 weeks)
- •Blood pressure <130/80 mm Hg at time of enrollment
- •Diabetic either Type 1 or 2
排除标准
- •GFR <60 m/min
- •Potassium > 5mg/dl at time of enrollment
- •History of Angioedema
- •ACE-I cough
- •Allergic to ARB, ACE-I, DRI
- •A1C > 9%
研究组 & 干预措施
Aliskiren in Macroalbuminuria
Aliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks.
干预措施: Aliskiren (Drug)
Aliskiren Microalbuminuria
Aliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks
干预措施: Aliskiren (Drug)
结局指标
主要结局
Reduction in albuminuria/proteinuria
时间窗: 6 weeks
次要结局
- Safety of Triple RAAS inhibition with ACE-I, ARB and DRI(6 weeks)
研究者
Pete Antonopoulos
Clinical Pharmacist
Cook County Health