NCT00907673已完成不适用
The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure
NovaShunt AG2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- To evaluate safety of the Automated Fluid Shunt device during a 28-week follow-up and to evaluate its efficacy by measuring change in NT-proBNP from baseline to 16 weeks, in patients with chronic congestive heart failure, ascites and diuretic resistance.
研究概览
简要总结
A 28-week, feasibility study to investigate the safety and efficiency of the Automatic Fluid Shunt in patients with chronic congestive heart failure, ascites and diuretic resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Female or male patients ≥ 18 years of age
- •A clinical diagnosis of chronic congestive heart failure > 6 months
- •At least one episode of documented ADHF during the previous 6 months
- •NYHA functional class III-IV
- •Circulating levels of NT-proBNP ≥ 800 ng/L.
- •Stable, optimized therapy for heart failure for at least 4 weeks prior to enrollment
- •Echocardiography performed within 3 months
- •Detectable ascites by ultrasound and/or computed tomography
- •Diuretic resistance defined as a daily dose of furosemide > 80 mg, torsemide > 40 mg or bumetanide > 2 mg
- •Written informed consent
排除标准
- •Present or recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
- •Ongoing malignant disease with adverse prognosis
- •Evidence of firmly loculated peritoneal effusion.
- •Obstructive uropathy
- •Severely reduced renal function (S-Creatinine 300 mol/l) or end-stage renal disease requiring dialysis
- •Severe liver disease (ASAT and/or ALAT and/or total bilirubin three times upper limit of normal range laboratory values)
- •Pregnancy
- •Requirement for intravenous inotropes
- •Acute coronary syndrome or any condition requiring emergency treatment
- •Heart disease requiring surgical intervention during the course of the study
- •Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator
结局指标
主要结局
To evaluate safety of the Automated Fluid Shunt device during a 28-week follow-up and to evaluate its efficacy by measuring change in NT-proBNP from baseline to 16 weeks, in patients with chronic congestive heart failure, ascites and diuretic resistance.
时间窗: 16 and 28 weeks
次要结局
- To determine the effect of AFS-treatment on functional capacity (NYHA class and 6-min. walking distance) compared from baseline to 16 and 28 weeks(16 and 28 weeks)
- To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks(16 and 28 weeks)
- To determine change in ascites, hydrothorax and leg edema (based on CT evaluation) compared from baseline to 16 and 28 weeks(16 and 28 weeks)
- To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks(16 and 28 weeks)
- To determine change in quality of life based on Minnesota Living with Heart Failure Questionnaire (MLHFQ) compared from baseline to 4, 12 and 28 weeks(baseline to 4, 12 and 28 week)
研究者
研究点 (2)
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