Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 6 minute walking test
研究概览
简要总结
CRT and ICD has known as decreasing cardiac mortality in patient with heart failure. Especially, it has reported that CRT improved cardiac systolic function, quality of life of patients with heart failure. However, CRT and primary ICD was not generalized in Korea. So the investigators will register patients who implant CRT or ICD (primary), and follow them up. During scheduled follow up, all patients will perform echocardiography, 6 minute walking test, EKG, Holter monitoring and questionnaire on QOL.
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
- •LV ejection fraction <40% or Clinical HF Symptom with (LV ejection fraction >40%)
- •medication for at least 3month
排除标准
- •patient who refuse to enroll the study
结局指标
主要结局
6 minute walking test
时间窗: 12 month later afer enrollment
for functional capacity
Transthoracic echocardiography (TTE)
时间窗: 12 month later afer enrollment
EKG
时间窗: 12 month later after enrollment
for Ventricular arrhythmia events
NYHA(New York Heart Association) evaluation
时间窗: 12 month later after enrollment
For functional capacity - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.
次要结局
- Cardiac MRI or Cardiac CT(12 month later afer enrollment)
- Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)(12 month later afer enrollment)