Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ♦ Phase I: To study changes on inflammatory markers after aortic valve replacement. ♦ Phase II: To study changes in left ventricular mass at the end of the study (12 months).
研究概览
简要总结
The purpose of the study is to see if statin therapy will optimize myocardial response to cardiopulmonary bypass during aortic valve replacement (AVR) for aortic valve stenosis (AVS) (Phase I) and optimize left ventricular reverse remodeling following AVR (Phase II). Preliminary evidence indicates that perioperative statin therapy reduce mortality and morbidity following cardiac surgery. Pleiotropic effects of statins may induce myocardial preconditioning and optimize myocardial and systemic responses to cardiopulmonary bypass during AVR. Furthermore statin therapy after AVR may contribute to an optimal left ventricular reverse remodeling.
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
- 70 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > or = 70 years and < 80 years
- •Severe aortic valve stenosis
- •Indication for aortic valve replacement by bioprothesis
- •Ejection fraction > or = 50%
- •Without treatment with statin- No renal failure
- •Informed consent signed
排除标准
- •Ischemic heart disaese
- •Concomitant surgery to aortic valve replacement
- •Emergency surgery- Known intolerance for statin
- •Pregnant woman
研究组 & 干预措施
1: Atorvastatin 80 mg.
Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
干预措施: Atorvastatin 80 mg (Drug)
结局指标
主要结局
♦ Phase I: To study changes on inflammatory markers after aortic valve replacement. ♦ Phase II: To study changes in left ventricular mass at the end of the study (12 months).
时间窗: 1 year
次要结局
- Phase I: To study changes on mitochondrial function, reactive oxygen species, and perioperative systolic and diastolic functions. Phase II: To study changes on clinical status, systolic and diastolic functions during the one-year follow-up.(1 year)