A Double-blind, Placebo-controlled, Randomized Trial Investigating the Safety and Efficacy of Additive Renin Inhibition With Aliskiren on Renal Blood Flow and Neurohormonal Activation in Patients With Chronic Heart Failure and Renal Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in renal blood flow as assessed by 131I-Hippuran clearance
研究概览
简要总结
The main purpose of this study is to examine the effect of add-on therapy with the direct renin inhibitor Aliskiren in comparison to placebo on renal blood flow in patients with heart failure and reduced renal function.
- Primary outcome measure: change in renal blood flow at 6 months
- Secondary outcome measures: changes in renal function, N-terminal pro Brain natriuretic peptide, left ventricular function, blood pressure and neurohormones
详细描述
This study is a randomized, double-blind, placebo controlled, parallel group comparison trial, enrolling 100 patients (67 vs. 33) with stable CHF. Patients will be randomized to Aliskiren 300 mg once daily or corresponding Placebo for a period of 6 months. Efficacy measures will be performed at baseline and at the end of the study. Primary efficacy outcome is change in renal blood flow as measured by 131I-Hippuran clearance. Secondary outcome include change in renal function, neurohormones, left ventricular function and blood pressure. Safety assessments include renal function, changes in electrolytes, and blood pressure. Patients will be uptitrated to maximum tolerated doses of Aliskiren, and safety visits are planned 1 week after initiation and on a 2 month interval afterwards. A total of 8 visits are planned during the entire study period.
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
- •NYHA II-IV Heart Failure
- •Left ventricular ejection fraction < 45%
- •Stable heart failure medication
- •eGFR by sMDRD formula between 30 and 60 mL/min/1.73m2
排除标准
- •Known hypersensitivity to study drug or ACEi
- •Concomitant treatment with both ARB and Aldosterone Receptor Antagonist
- •Symptomatic Hypotension
- •Acute Heart Failure
- •History of stroke, acute coronary syndrome, PCI or angioplasty within past 3 months
- •Serum potassium > 5.2 mmol/L
- •Right heart failure due to severe pulmonary disease
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Aliskiren
干预措施: Aliskiren (Drug)
结局指标
主要结局
Change in renal blood flow as assessed by 131I-Hippuran clearance
时间窗: 6 months
次要结局
- change in glomerular filtration rate (GFR) as assessed by 125I-Iothalamate(6 months)
- Change in systolic and diastolic blood pressure(6 months)
- change in N-terminal pro brain natriuretic peptide levels (NT-proBNP)(6 months)
- Change in left ventricular ejection fraction(6 months)
- change in NYHA class, change in filtration fraction, change in albumin excretion, change in tubular function parameters, change in neurohormonal activation(6 months)
研究者
H.L. Hillege
Prof.dr.
University Medical Center Groningen