NCT01022463已完成3 期
Effect of Ivabradine vs Atenolol on Heart Rate and Effort Tolerance in Patients With Mild to Moderate Mitral Stenosis and Normal Sinus Rhythm
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks
研究概览
简要总结
The purpose of this study is to study the effect of Ivabradine vs Atenolol on heart rate and effort tolerance in patients with mild to moderate mitral stenosis and normal sinus rhythm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate mitral stenosis (Mitral valve area: 1.0 cm2 - 2.0 cm2 on echocardiography) with normal sinus rhythm
- •Age >18 years
- •Need for rate control therapy for symptoms
排除标准
- •Atrial fibrillation
- •Other significant valvular lesions (More than mild AS/AR/MR)
- •Denial of consent
- •Unable to do TMT/Contraindication for TMT
- •Need for surgical treatment or BMV
- •Presence of significant non-cardiac co-morbidities
研究组 & 干预措施
Ivabradine
Active Comparator
Crossover study to compare ivabradine and atenolol
干预措施: Ivabradine (Drug)
Ivabradine
Active Comparator
Crossover study to compare ivabradine and atenolol
干预措施: Atenolol (Drug)
Atenolol
Placebo Comparator
干预措施: Atenolol (Drug)
结局指标
主要结局
Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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