NCT00701285已完成4 期
A Prospective, Randomized, Two Group Comparison Study to Evaluate the Effect of Statin on Heart Function in Patients With Chronic Ischemic Heart Failure.
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2008年7月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Rate and number of hospitalization for cardiovascular cause; Lipid profile
研究概览
简要总结
We want to evaluate the utility of statins on heart function according to potency. Patients with chronic ischemic heart failure are administered pitavastatin 4mg or pravastatin 10mg for 52 weeks. Then we evaluate the effect of pitavastatin and pravastatin primarily on rate of hospitalization for cardiovascular cause and lipid profile secondarily biomarker, echocardiography parameter, 6-minute walk, change of NYHA class distribution, cardiovascular mortality.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who accepted to enter the study by written informed consent
- •Age ≥ 30 years
- •LDL-cholesterol ≥ 70mg/dl
- •Chronic heart failure of :
- •NYHA class II ~ III
- •Ischemic etiology
- •Left ventricular ejection fraction < 45%
- •Optimal therapy for chronic heart failure and stable clinical condition over the two weeks.
排除标准
- •Patients who participated in other studies 3 months before enrollment
- •Statin treatment within 2 months before enrollment
- •Unstable decompensated heart failure at enrollment
- •Acute coronary syndrome or cerebral vascular disease within 3 months before enrollment
- •Coronary revascularization within 3 months before enrollment or planned at enrollment
- •Any other serious disease or condition which might effect life expectancy such as malignancy, life-threatening infectious disease.
- •Serum creatinine levels >= 3.0 mg/dl
- •AST or AST levels >=2.5 times of ULN
- •CK levels >=2 times of ULN
- •Uncontrolled hypothyroidism : TSH level >= 2 times of ULN
- •Pregnant or breastfeeding women, women who want to bearing
- •Patients who might to be unsuitable by the decision of investigators
研究组 & 干预措施
2
Active Comparator
mild statin
干预措施: pravastatin (Drug)
1
Active Comparator
strong statin
干预措施: pitavastatin (Drug)
结局指标
主要结局
Rate and number of hospitalization for cardiovascular cause; Lipid profile
时间窗: 52week
次要结局
- Biomarker : BNP, hsCRP, IL-6. TNF-α(52 week)
- Echocardiography : LVEF, E/A ratio, LVEDD, LVESD(52 week)
- Cardiac function evaluation (NYHA class distribution, 6-minute walk test)(52 week)
- Cardiovascular mortality(52 week)
研究者
研究点 (1)
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