Double Blind Randomized Phase IV Clinical Trial to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in the Haemodynamic Progression of Degenerative Aortic Stenosis. The AORTICA 1 Study.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- To study changes in CRP (mg/dL) concentration at the end of the study (12 months)
研究概览
简要总结
Atherosclerosis and aortic stenosis share inflammatory etiopathogenic characteristics in common. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease.
详细描述
This study will be a prospective, phase IV-III, randomized, double blinded, active controlled study, to evaluate the efficacy of fluvastatin on inflammatory markers in the haemodynamic progression of degenerative aortic stenosis. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease. Eligible patients with degenerative aortic stenosis will be randomized 1:1 to fluvastatin 80 mg once daily or placebo. The treatment should be continued until the study end (12 months). Follow up investigations will be performed after 3 months and at the end of the study (12 months).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Asymptomatic
- •Aortic stenosis defined as aortic valve leaflet thickening with reduced systolic opening (maximum aortic jet velocity >2 m/s)
- •Written informed consent to participate in the study
- •Patients capable to follow all conditions along the study.
排除标准
- •Symptomatic patients caused by aortic stenosis.
- •Patients on statins anytime in the year before inclusion.
- •Patients diagnosed of dyslipidemia requiring statins.
- •Temperature ³37,8 ºC in the week before inclusion.
- •Any cardiovascular event succeeding in the three months before inclusion
- •Known thyrotoxicosis
- •Renal failure requiring hemodialysis
- •Any inflammatory noncardiac diseases or other reasons known to influence the study biomarkers concentrations.
- •Any surgery succeeding in the three months before inclusion.
- •Patients with any hepatopathy that in the view of the investigator prohibits participation in the study.
- •Patients with known muscular disease.
- •Patients with any severe medical condition that in the view of the investigator prohibits participation in the study
- •Use of corticoids, immunosuppressors or non steroid drugs.
- •Any known sensitivity to study drug (fluvastatin) or class of study drug.
- •Patients participating in any study in the last year.
- •Women of childbearing potential not using the contraception method(s) specified in this study, suspicion of pregnancy, as well as women who are breastfeeding
研究组 & 干预措施
fluvastatin
fluvastatin 80 mg
干预措施: Fluvastatin (Drug)
placebo
干预措施: Fluvastatin (Drug)
结局指标
主要结局
To study changes in CRP (mg/dL) concentration at the end of the study (12 months)
时间窗: 12 months
次要结局
- To study changes in other inflammatory biomarkers (specify in the protocol) at the end of the study (12 months)(12 months)
- To study changes in these biomarkers in the different grades of aortic stenosis at the end of the study (12 months)(12 months)
- To study the safety and tolerability of fluvastatin in patients with aortic stenosis.(12 months)
- To study changes change in aortic valve area and medium aortic transvalvular gradient at the end of the study (12 months)(12 months)
研究者
Pedro L Sanchez
MD, PhD
AORTICA Group