NCT01447069Unknown不适用
Use of Beta-agonists in Stable Severe Congestive Heart Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in plasma level of N-terminal pro-BNP at twelve weeks relative to baseline pro-BNP.
研究概览
简要总结
The purpose of this study is to determine whether Salbutamol is effective in the treatment of severe heart failure due to ischemic and non- ischemic cardiomyopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory Patients with a diagnosis of ischemic and non-ischemic cardiomyopathy with a measured EF <35%, class III as defined by the NYHA with ICD and who receive optimal pharmacological therapy.
排除标准
- •Heart Failure class I, II, IV
- •atrial fibrillation
- •any significant valvular disease
- •chronic obstructive pulmonary disease who treated with inhaled β2 agonist
- •significant kidney disease with eGFR <30%
- •severe uncontrolled electrolyte abnormalities
- •prior allergic reaction to Salbutamol
- •Pregnancy and nursing women
研究组 & 干预措施
Salbutamol
Active Comparator
The patients in the study groups will receive the selective β2 agonist, Salbutamol, in addition to their ongoing optimal heart failure therapy.
干预措施: Salbutamol (Drug)
结局指标
主要结局
Changes in plasma level of N-terminal pro-BNP at twelve weeks relative to baseline pro-BNP.
时间窗: 12 weeks from baseline pro-BNP assessment
次要结局
- Adverse cardiovascular event: Death, ICD discharge, significant ventricular arrhythmias and hospitalization due to heart failure exacerbation(12 weeks after baseline assessment)
- NYHA class changes(12 weeks after baseline assessment)
- Echocardiography parameters changes(12 weeks after baseline assessment)
- Minnesota Living with Heart Failure Questionnaire changes(12 weeks after baseline assessment)
- Non-ventricular arrhythmias and electrolytes disturbances(baseline, 1 week, 4 weeks, 8 weeks and 12 weeks)
研究者
研究点 (1)
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