COR HF - Clinical Benefits in Optimized Remote HF Patient Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 21
- 主要终点
- Combined Endpoint on Patient Clinical Outcome
研究概览
简要总结
The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of recurrent atrial tachycardia or atrial fibrillation episodes and in the reduction of inappropriate shock therapies. The remote care allows early intervention in terms of drug therapy adjustment and cardiac resynchronization therapy (CRT-D) device reprogramming.
详细描述
The outcome measure of the study is a combined endpoint of:
- Proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months
- Proportion of patients with inappropriate Implantable Cardioverter-Defibrillator (ICD) therapies delivered at 12 months comparing optimized remote patient management to optimized standard patient management
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure patients already implanted with CRT-D devices (from 4 to 8 weeks), according to current guidelines1
- •1 hospitalization or access to emergency unit due to heart failure (including treatment with diuretic and/or cardioactive intravenous therapy) within the last 12 months
- •Left Bundle Branch Block (LBBB)
- •Patients must be able to provide written informed consent
- •Patients are mentally capable to participate in the Investigation (based on physician's discretion)
排除标准
- •Patients already implanted with CRT or CRT-D device to be replaced
- •Patients in long-standing persistent or permanent AT/AF
- •Patients in dialysis treatment at the time of enrollment
- •Patients in parenteral inotropic therapy at the time of enrollment
- •Patients with epicardial Left Ventricular (LV) lead
- •Patients with mechanical valvular prosthesis
- •Patients with life expectancy < 12 months
- •Patients actively considered for cardiac transplant
- •Patients < 18 years old
- •Pregnant women
结局指标
主要结局
Combined Endpoint on Patient Clinical Outcome
时间窗: 12 months follow up
Combined Endpoint: * proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months * proportion of patients with inappropriate Implantable Cardiac Defibrillator (ICD) therapies delivered at 12 months
次要结局
未报告次要终点