NCT02047422撤回不适用
A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Compare the Effectiveness and Safety of DIuretics Add-On Strategy in Acute Decompensated Heart Failure Patients (DIOS II)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- urine output change
研究概览
简要总结
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dyspnea at rest or minimal activity
- •tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray
排除标准
- •hospitalization for acute heart failure decompensation
- •cardiogenic shock (Systolic Blood Pressure < 80mmHg)
- •Need or plan for renal replacement therapy (dialysis, kidney transplant)
- •serum creatine level > 2.5mg/dl
- •serum potassium (K+) > 5.5mg/dl
- •Age > 80 years old or poor compliance patients
- •allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics
- •life expectancy < 6 months (e.g. metastatic malignancy, liver cirrhosis)
- •pregnancy or women at age of childbearing potential
研究组 & 干预措施
Add furosemide/no spironolactone
Experimental
干预措施: Furosemide (Drug)
Add metolazone/no spironolactone
Experimental
干预措施: metolazone (Drug)
Add furosemid/spironolactone
Experimental
干预措施: furosemid/spironolactone (Drug)
Add metolazone/spironolactone
Experimental
干预措施: metolazone/spironolactone (Drug)
结局指标
主要结局
urine output change
时间窗: from admission to Hospital Day (HOD)#4
efficacy of diuretics add-on therapy, urine output change
次要结局
- serum creatinine change(from admission to HOD#4)
研究者
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