NCT01127945已完成不适用
A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- hsCRP levels
研究概览
简要总结
This is a prospective, single-center, randomized, controlled, open-label, pilot study to evaluate the effectiveness of high dose statin loading in acute 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
- •Acute coronary Syndrome
- •Hospitalization plan for PTCA or CABG
- •Cardiogenic shock (Systolic Blood Pressure < 80mmHg)
- •Uncontrolled hypertension (Systolic Blood Pressure > 180mmHg)
- •Allergy, adverse drug reaction, hypersensitivity to statin
- •Troponin > 5 times upper limit of normal (ULN)
- •Creatinine kinase-MB level > 3 times ULN
- •AST, ALT > 3 times ULN or acute hepatitis
- •Current or past history of muscle disease, rhabdomyolysis
- •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
atorvastatin 80mg
Experimental
干预措施: statin (Drug)
conventional therapy (for heart failure)
Active Comparator
干预措施: statin (Drug)
结局指标
主要结局
hsCRP levels
时间窗: at hospital day #4
to investigate the effect of high dose statin loading on the change of serum NT-proBNP, hsCRP levels in patients with acute heart failure
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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