Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of biventricular pacing >95%
研究概览
简要总结
The purpose of this study is to determine the role of ivabradine in cardiac resynchronization recipients with an unsatisfactory percentage biventricular pacing.
The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV treated with optimal medical therapy as clinically indicated who received CRT-D device more than 3 months ago. Patients with biventricular pacing <95% will and heart rate <70 at rest and >50% of heart rate in device memory >70 will receive ivabradine. The minimal follow-up of patients in the study will be at least six months.
详细描述
Approximately 30% of CRT recipients do not respond to therapy. One of the causes ot that is unsatisfactory percentage of biventricular pacing. Patients may loose biventricular pacing because of inadequate sinus tachycardia.
Ivabradine may prevent inadequate sinus tachycardia and improve quality of live of CRT recipients.
According to current guidelines ivabradine is recommended in patients with symptomatic heart failure with heart rate at rest >70.
The hypothesis of this study is that ivabradine may increase percentage of biventricular pacing in CRT recipients who have unsatisfactory percentage of biventricular pacing and >50% of heart rate in device memory >70.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heart failure NYHA II-IV
- •left ventricular ejection fraction =<35%
- •CRT-D implanted over 3 months ago
- •optimal CRT-D parameters
- •biventricular pacing <95% despite the optimal parameters of the device
- •optimal pharmacotherapy with the highest well-tolerated beta-adrenolytic dosage
- •heart rate at rest below 70 bpm
- •over 50% of heart rhythm over 70 bpm at interrogation with the device
排除标准
- •persistent atrial fibrillation/flutter
- •device associated ineffective resynchronization
- •contraindications to ivabradine
研究组 & 干预措施
Ivabradine
Ivabradine 5 mg twice a day or 7,5 mg twice a day
干预措施: Ivabradine (Drug)
结局指标
主要结局
Percentage of biventricular pacing >95%
时间窗: 6 months
次要结局
- Percentage of biventricular pacing >98%(6 months)
- Time to first inappropriate shock(6 months)
- change of mean heart rate compared with baseline(6 months)
- Cardiovascular hospitalization(6 months)
- The change between baseline and final echocardiographic parameters(6 months)
- The assessment of quality of life (SF36)(6 months)
- The change between baseline and final NYHA class(6 months)
研究者
Marcin Grabowski
PhD
Medical University of Warsaw