Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- number of hospitalizations for heart failure
研究概览
简要总结
Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment.
详细描述
Patients with severe heart failure (New York Heart Association [NYHA] III-IV) and fluid overload will be randomized to ultrafiltration (UF group) or conventional medical treatment (Control group). Patients follow-up at least monthly visit for one year. Ultrafiltration will be repeated during follow-up in case of body weight gain due to fluid accumulation. Ultrafiltration will be performed during short term hospitalization.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe heart failure (NYHA III-IV) with fluid overload
- •Ejection fraction < 40%
- •Estimated fluid overload > 4 kg
排除标准
- •Severe renal insufficiency
- •Acute pulmonary edema and/or cardiogenic shock
结局指标
主要结局
number of hospitalizations for heart failure
时间窗: End of study
次要结局
- long term major adverse clinical events including death(End of study)
研究者
Piergiuseppe Agostoni
MD PhD
Centro Cardiologico Monzino