Ivabradine for Rate Control in Permanent Atrial Fibrillation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percent Pacing in Daily Life
研究概览
简要总结
Ivabradine may be useful as a rate controlling agent in atrial fibrillation without negative effects on hemodynamics and inotropy. The objective in this proof of concept study is to investigate the hypothesis that ivabradine will slow the ventricular response in patients with permanent atrial fibrillation and previously-implanted pacemakers.
详细描述
In a simple cross-over study, the investigators will evaluate the impact of oral Ivabradine on exercise treadmill test, percent pacing as stored in pacemaker diagnostics, and 6 minute walk test.
Aim/Hypotheses
• To determine if the addition of Ivabradine to baseline cardiac medications slows mean and maximum heart rates in permanent atrial fibrillation
- Ivabradine will lower mean and maximum heart rates on treadmill exercise test, without lowering blood pressure
- Ivabradine will increase percent pacing, and lower rates over time as shown on pacemaker diagnostic data
- Ivabradine will improve exertional symptoms and exercise tolerance due to atrial fibrillation as measured by the Borg's scale during a six-minute walk test.
Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with stable blood pressures with permanent atrial fibrillation and implanted pacemaker pacing less than 50% of the time, with or without concomitant beta blocker or calcium channel blocker use
排除标准
- •Patients with uncontrolled hypertension will be excluded
- •To eliminate confounding effects, patients on Digoxin therapy will be excluded
- •Patients on anti-arrhythmic therapy
- •Patients with pre-excitation on EKG
- •Patients who pace > 50% of the time
- •Patients with severe Child-Pugh C hepatic impairment
研究组 & 干预措施
Ivabradine
Patients with permanent atrial fibrillation and previously implanted pacemakers who will be started on ivabradine.
干预措施: Ivabradine (Drug)
结局指标
主要结局
Percent Pacing in Daily Life
时间窗: 2 weeks
Average percent pacing derived using pacemaker interrogation over 2 weeks
Heart Rate in Daily Life
时间窗: 2 weeks
Average ventricular heart rate derived using pacemaker interrogation over 2 weeks
Heart Rate on Treadmill
时间窗: 2 weeks
Average ventricular heart rate will be recorded after the patient exercises on a treadmill using a heart rate monitor
Symptoms and Exercise Tolerance
时间窗: 2 weeks
Patients will undergo a 6 minute walk test, and symptoms and distance walked as measured by standard 6 minute walk protocol
次要结局
- Blood Pressure(2 weeks)