Atrial Fibrillation Rate Control Therapy Guided By Continuous Ambulatory Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to adequate heart rate (HR) control, defined as resting heart rate ≤ 80 bpm and average heart rate over 24 hours < 100 and no recorded HR > 110% of maximum age-adjusted predicted HR.
研究概览
简要总结
The purpose of this study is to demonstrate that the use of a continuous ambulatory monitoring device will reduce both the time to effective rate control and the health care expenditures associated with standard methods of rate control monitoring in patients presenting with atrial fibrillation with a rapid heart rate.
详细描述
This is an open, randomized controlled trial to compare a standard rate-control strategy with one using the Cardionet device to guide therapy for the management of atrial fibrillation. Patients presenting to an outpatient clinic or to the Emergency Department with atrial fibrillation with a ventricular rate greater than 100 bpm at rest will be enrolled.
Treatment:
Patients will be prescribed either a beta blocker or a calcium channel blocker, or have their baseline dose increased if already taking one of these agents at the discretion of the treating physician. This is consistent with standard outpatient treatment guidelines for rate control in atrial fibrillation.
Randomization:
At the time of enrollment, patients will be randomized to a standard rate control protocol or a rate-control protocol guided by the Cardionet device.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrial fibrillation with resting ventricular rate > 100 with rate control strategy indicated
- •Atrial fibrillation is likely to be recurrent or persistent in the clinical judgment of the physician
- •Patient able to be managed out of the hospital
- •Ability to sign informed consent
- •Ability to wear electrodes for the Cardionet device
- •Patient willing to have home patient educator install Cardionet monitor in their home
排除标准
- •Inability to follow up with prescribed schedule of monitoring
- •Concomitant use of antiarrhythmic drug
- •Indication for hospitalization
结局指标
主要结局
Time to adequate heart rate (HR) control, defined as resting heart rate ≤ 80 bpm and average heart rate over 24 hours < 100 and no recorded HR > 110% of maximum age-adjusted predicted HR.
次要结局
- Total health care costs associated with conventional and Cardionet based monitoring strategy.
研究者
Peter Zimetbaum
Richard A. and Susan F. Smith Professor of Medicine in the Field of Cardiovascular Medicine
Beth Israel Deaconess Medical Center