NCT00421005Unknown4 期
Safety and Efficacy of Fluvastatin in Heart Transplant Recipients
University of Bologna1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2004年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 56
- 试验地点
- 1
研究概览
简要总结
Statin therapy is a treatment with a proven positive impact on survival after heart transplantation. However, it is unclear whether the beneficial effect of this class of drugs depends solely on their LDL-lowering properties or on anti-inflammatory and immuno-modulatory properties. Thus, this study was designed to compare safety and efficacy of two different strategies: 1. high fixed statin dose vs. 2. low starting dose with LDL-driven doses adjustments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •De novo heart transplantation
排除标准
- •Known allergy/intolerance to fluvastatin;
- •Preexisting neuromuscular disorders;
- •Significant liver disease and/or elevation of transaminase exceeding 3 times the ULN
- •Severe renal impairment : creatinine > 3 mg/dL
- •Intellectual/cognitive impairment likely to compromise informed consent or adherence to protocol or age <18 years.
- •Patients refusal
- •Pregnancy
研究组 & 干预措施
1
Experimental
Fluvastatin 80mg
干预措施: fluvastatin (Drug)
2
Active Comparator
Fluvastatin 20, tapered up according to LDL concentration
干预措施: fluvastatin (Drug)
研究者
研究点 (1)
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