Hyperemic Efficacy of Intravenous Infusion of Adenosine in Heart Failure With Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Failure to induce maximal hyperemia
研究概览
简要总结
Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment using a coronary pressure wire.
详细描述
Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment using a coronary pressure wire. Patients with an angiographically intermediate lesion (40-70% diameter stenosis) in a major epicardial coronary artery and with left ventricle ejection fraction ≤40% will be prospectively enrolled. FFR under the various hyperemic stimulation using IV adenosine 140 & 180, IC adenosine, and IC nicorandil will be measured sequentially.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •angiographically proven epicardial intermediate stenosis (40-70%)
- •echocardiographically proven LV dysfunction (LVEF ≤40%)
排除标准
- •infarct-related artery, less than 2 weeks
- •Killip class 3 and 4
- •bronchial asthma
- •second degree or third degree AV block
- •any contraindications to adenosine
研究组 & 干预措施
Nicorandil followed by adenosine
干预措施: Maximal hyperemia with nicorandil followed by adenosine (Other)
Adenosine followed by nicorandil
干预措施: Maximal hyperemia with adenosine followed by nicorandil (Other)
结局指标
主要结局
Failure to induce maximal hyperemia
时间窗: less than 1 day
no hyperemia, cyclic hyperemia, and submaximal hyperemia
次要结局
- Fractional flow reserve(less than 1 day)
- time to maximal hyperemia(less than 1 day)