NCT00400582已完成4 期
Effect of ACE Inhibitor Plus High Dose Candesartan on BNP and Inflammation in Patients With LV Dysfunction: Impact of Renin-angiotensin-aldosterone System Genetic Polymorphisms
Montreal Heart Institute2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- BNP and NT-proBNP
研究概览
简要总结
The purpose of this study is to evaluate the impact of genetic variations on the response to candesartan in patients with heart failure who are already treated with an ACE inhibitor.
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
- •Principal Inclusion Criteria:
- •Male or female > or = 18 years old.
- •Symptomatic CHF corresponding to NYHA class II-IV symptoms for at least 4 weeks prior randomization.
- •LVEF < or = 40%
- •Treatment with an optimal and stable dose of ACE inhibitor for at least 4 weeks prior to enrolment in the study.
排除标准
- •Treatment with an ARB within 8 weeks prior to randomization.
- •Known hypersensitivity to ARBs or ACE inhibitors.
- •Creatinine clearance < 30 ml/min or serum creatinine > 221
- •Current serum potassium > or = 5.0 mmol/L or a history of marked ACE inhibitor or ARB induced hyperkalemia.
- •Known bilateral renal artery stenosis.
- •Current symptomatic hypotension and/or systolic B.P. < 90 mmHg.
- •Decompensated heart failure described as hospitalization or I.V. administration of medication in emergency room or heart failure clinic within 4 weeks
- •Stroke, acute coronary syndrome, PCI within the last 4 weeks before randomization.
- •Connective tissue disease or chronic inflammatory condition
- •Acute inflammatory process such as an infection or gout attack in the last 2 weeks.
- •Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception.
结局指标
主要结局
BNP and NT-proBNP
时间窗: 16 weeks
次要结局
- Blood pressure(16 weeks)
- CRP(16 weeks)
- Renin(16 weeks)
- Aldosterone(16 weeks)
- Insulin resistance/ glucose(16 weeks)
- NYHA functional class(16 weeks)
- Tolerability(16 weeks)
研究者
研究点 (2)
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