The Comparison With Clinical Impacts on Functional Capacity and Symptom Improvement According to the Rhythm Control in Patients With Heart Failure and Recent Onset Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation
研究概览
简要总结
Prospective randomized (rhythm control or rate control in heart failure patients with new onset atrial fibrillation) Objective of study 1. To analyze long term outcome of patients with heart failure with new onset atrial fibrillation according to the rhythm control 2. To analyze remodeling of atrium and ventricle by the new onset AF in heart failure patients 3. To analyze the change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF
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
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Heart failure and Atrial fibrillation within 1year (20~80 years old)
- •LA diameter < 5mm
- •LVEF 20~49%
- •patients possible to anticoagulation and anti arrhythmic drug
- •Expected survival >1yr
排除标准
- •Impossible to anticoagulation or anti arrhythmic drug
- •valvular atrial fibrillation ( Mitral valve stenosis, Mitral valve plasty, valve replacement)
- •LV ejection fraction < 20%
- •Structural cardiac disease
- •Catheter ablation history for AF, maze surgery
- •patient with severe medical disease
- •Impossible to anticoagulation or anti arrhythmic drug
研究组 & 干预措施
Sinus Rhythm Control group
- Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation
- Cardioversion after 1 month
- Rhythm FU schedule (2012 ACC/AHA/ESC guidelines)
- If AF recur, RFCA
干预措施: Sinus Rhythm control (Procedure)
Pulse Rate Control Group
- No AAD, just anticoagulation
- HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin)
- Without the treatment about antiarrhythmia and rhythm control, diffraction of rate control, the subject will be drop out for study.
干预措施: Pulse Rate control (Procedure)
结局指标
主要结局
improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation
时间窗: 1 year
ejection fraction change (echocardiography)
functional capacity according to the rhythm control in patient with heart failure and new onset atrial fibrillation
时间窗: 1 year
peak VO2 (cardio pulmonary test ; CPX)
次要结局
- remodeling of atrium by the new onset AF in heart failure patients The change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF(1 years late)
- remodeling of ventricle by the new onset AF in heart failure patients The change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF(1 years late)