The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal Failure
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation
研究概览
简要总结
Carperitide (alpha-human atrial natriuretic peptide) improves systemic hemodynamics in patients with heart failure through a vasodilatory action, a natriuretic action, and inhibition of the renin-angiotensin-aldosterone system and has been widely-used in Japan. However, a paucity of report is available on the effects of carperitide on short and long-term prognosis in patients with both cardiac and renal failure. The purpose of this study is to evaluate the effects of carperitide therapy on short and long-term prognosis in patients with both cardiac and renal failure, in comparison with standard therapy.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure of any etiology, diagnosed according to Framingham criteria
- •Estimated GFR </= 60 ml/min/1.73 m2)
排除标准
- •Severe heart failure required percutaneous cardiopulmonary bypass support (PCPS)
- •End-stage renal failure on maintenance dialysis
- •Severe hepatic dysfunction
- •Severe anemia
- •Allergic history of carperitide
- •Pregnant women
研究组 & 干预措施
Standard Therapy
Standard heart failure therapy excluding carperitide administration
干预措施: Standard heart failure therapy (Drug)
Carperitide Therapy
Addition of carperitide administration to standard heart failure therapy
干预措施: Carperitide heart failure therapy (Drug)
结局指标
主要结局
Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation
时间窗: at 6 months and 2 years
次要结局
- All cause mortality(at discharge, 6 months, and 2 years)
- Sudden death(at discharge, 6 months, and 2 years)
- Cardiovascular death(at discharge, 6 months, and 2 years)
- Plasma B-type natriuretic peptide concentration(at discharge, 6 months, and 2 years)
- Estimated GFR(at discharge, 6 months, and 2 years)