Beat-to-beat Variability in Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Atrial fibrillation symptoms
研究概览
简要总结
Heart rate variability (HRV) in patients with atrial fibrillation (AF) is hardly studied. Though a reduced HRV in patients with heart failure and reduced ejection fraction (HFrEF) has been associated with poor prognosis. Data on HRV in AF-patients without a reduced ejection fraction is lacking. We hypothesize that those patients with persistent atrial fibrillation and larger beat-to-beat variability would be more symptomatic than does those with smaller HRV. To asses this theory we intend to perform a prospective observational trial. Symptoms of Atrial fibrillation will be assessed using Quality of Life questionnaires and 6 minutes walking test. Heart rate variability will be assessed using 24 hour Holter ECG monitoring.
The correlation between symptoms and heart rate variability will be then assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Persistent atrial fibrillation
- •No previous ablation for atrial fibrillation
- •At least 18 years old
- •Signed written patient's informed consent
排除标准
- •Paroxysmal atrial fibrillation
- •Previous ablation therapy for atrial fibrillation
- •Reduced left ventricular ejection fraction (LVEF<35%)
- •Permanent ventricular pacing (including cardiac resynchronization therapy CRT)
- •Acute coronary syndrome (ACS) during past 6 weeks.
- •Stroke or TIA within past 6 weeks.
- •Cardiac surgical operation/ intervention within past 3 months.
- •Acute decompensated heart failure
- •Treatment with IV Inotropic medications (e.g. Dobutamine, Levosimendan)
- •Mitral valve replacement or rheumatic mitral valve stenosis
- •Neurological or psychological disease that may impair patient's judgement or compliance
- •Pregnancy or Breast-feeding women.
结局指标
主要结局
Atrial fibrillation symptoms
时间窗: 7 days
Whether atrial fibrillation symptoms assessed by Quality-of-Life questionnaires correlates with heart rate variability
次要结局
- Atrial fibrillation symptoms(7 days)
- Improvement in 6MWD (6 minutes walk distance)(7 days)