Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve (BICATOR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 10
- 主要终点
- Change of the diameter of ascending aorta by CT (Computed Tomography).
研究概览
简要总结
Bicuspid Aortic Valve (BAV) is the most common congenital heart disease affecting 1-2% of the population. The aortic dilation and aortic valve degeneration are common complications in patients with BAV. Statins have shown a reduction in the expression of metalloproteinases of the extracellular matrix observed in aortic aneurisms. Several retrospective studies have suggested the benefit of the statins to reduce aortic dilation in patients with BAV. Moreover, although statins did not show to be useful in the progression of aortic stenosis, different studies have suggested a higher profit when the valve affection is not severe. The objective of this study is to determine whether atorvastatin is effective at reducing the progression of aortic dilation in patients with BAV.
详细描述
BICATOR is a multicentre (8 centres), randomised, double-blind and placebo-controlled clinical trial aimed at evaluating the effect of atorvastatin in reducing progression of aortic dilation in patients with BAV. The primary outcome is to determine whether atorvastatin is effective in reducing aortic dilation in BAV and secondary outcome is to define if atorvastatin treatment slows the progression of aortic valve degeneration (valve calcification) in a 3 year follow-up period. 220 patients will be included (110 atorvastatin - 110 placebo).
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
- 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
- •Patients ≥ 18 years old with BAV confirmed by transthoracic echocardiography (in case of doubts other techniques will be required: transesophageal echocardiography or CT to confirm diagnosis).
- •Valve dysfunction only moderate: in case of aortic stenosis with average gradient < 30 mmHg and in case of aortic regurgitation a vena contracta < 7 mm or a jet with < 10 mm.
- •Aortic valve not show severe calcification by transthoracic echocardiography.
- •Ascending aortic diameter (Valsalva sinus or tubular ascending aorta) ≤ 50 mm.
- •The patient must give the consent form signed.
排除标准
- •Patients younger than
- •Patients with uncontrolled hypertension and a history or risk of diabetes mellitus.
- •Patients who receive statins treatment or other lipid lowering drug or if they have indication to be treated according to the current clinical practice guidelines.
- •Previous cardiac surgery or any surgery of other segments of the aorta.
- •Previous aortic dissection and/or aortic coarctation.
- •NYHA functional class III or IV.
- •Presence or antecedent of liver failure (transaminase > 2 fold the superior limit of normal levels according to local laboratory), renal failure (creatinine clearance < 30ml/min or creatinine > 2.5mg/dl), myopathy or creatine kinase levels > 5 fold the superior limit of normality, or other gastrointestinal, hematologic or endocrine diseases or any other situation that according to the investigator criteria could affect the study treatment evaluation.
- •Hypersensitivity, intolerance or contraindication to any component of the study drug or to the contrast used in CT.
- •Pregnancy, breastfeeding or desire for pregnancy during the study period. A negative pregnancy test (negative gonadotropin) will be required in all fertile women to participate in the study.
- •Participation in another drug study.
研究组 & 干预措施
Atorvastatin
Oral administration Atorvastatin 20 mg per day
干预措施: Atorvastatin (Drug)
Control
Oral administration of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change of the diameter of ascending aorta by CT (Computed Tomography).
时间窗: 3 years
Determination of the progression of ascending aortic dilation assessed by measuring the change of the diameter of ascending aorta by CT (Computed Tomography).The change of the aortic diameter will be defined by the major difference between the measurements taken in the aortic root and ascending aorta in the initial and final study.
次要结局
- Change of the final maximum diameter of the tubular ascending aorta and the basal measured by CT.(3 years)
- Change of the final area of the aortic root and the basal measured by CT.(3 years)
- Change of the final planimetry area of the aortic valve and the basal measured by CT.(3 years)
- Change of the transvalvular pressure gradient of the aortic valve(3 years)
- Change of aortic regurgitation jet width basal and final.(3 years)
- Change of the maximum aortic velocity(3 years)
- Change of aortic valve area(3 years)
- Ocurrence of Serious Adverse Clinical Events leading to hospitalization and death(3 years)
- Change of the the final area of ascending aorta and the basal measured by CT.(3 years)
- Change of the valve Agatston final score and the basal assessed by CT.(3 years)
- Change of the final maximum diameter of the aortic root and the basal measured by CT.(3 years)