Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve
Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve
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.
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).
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  Patients younger than 18.

 -  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.