Management of Chronic Heart Failure: Role of the Handled Echocardiography in Home Monitoring Care Programs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events
研究概览
简要总结
The aim of the study is to compare two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations, the other one using also periodical handled echocardiographic examinations.
详细描述
Randomized, blinded, controlled, monocentric study comparing two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations every three months, the other one using also periodical handheld echocardiographic examinations at the 6th, 12th and 18th month.
The events occurring during the 18 month follow up and the results of the final echocardiography performed in all the patients will be transmitted to and evaluated by an independent observer, unaware of the features of the follow up. At the end of the trial, the randomization code will be opened and the events will be ascribed to the two groups. The primary end point is rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events during the 18 months follow up. Secondary end points include home treated vascular events, cardiovascular death and the composite end point death + rehospitalization.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Heart Failure in functional class NYHA III
- •At least once hospitalization during the last year for worsening of clinical symptoms or for the appearance of acute cardiovascular events
- •Patients who cannot easily reach the pertaining Sanitary District for different reasons (i.e. the presence of architectural barriers, the absence of a lift, a too great distance between home and Sanitary District without someone helping)
- •age ≥ 70 years
- •written informed consent
排除标准
- •Patients who were waiting for cardiac surgery or patients who had undergone a cardiac operation within three months
结局指标
主要结局
Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events
时间窗: 18 months
次要结局
- Home treated major vascular events(18 months)
- Cardiovascular death(18 months)
- Composite end point death + rehospitalization(18 months)