Statin Therapy in Asymptomatic Aortic Stenosis
Statin Therapy in Asymptomatic Aortic Stenosis
There is evidence that the degenerative changes leading to aortic stenosis are caused by a
 chronic inflammatory process. Furthermore the development of aortic stenosis is partially
 dependent on typical cardiovascular risk factors. An inflammatory process as well as those
 risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase
 inhibitors) would be an appealing concept to reduce both those risks for development of
 aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the
 progression of aortic stenosis.
This study will be a prospective, double-blind, placebo-controlled, two-armed clinical trial
 trial to test the influence of statin therapy on the progression of calcified aortic stenosis
 in patients with asymptomatic mild to moderate aortic stenosis. After completion of all
 baseline investigations patients will be randomly assigned to the verum group (fluvastatin
 group) or to the control group (placebo group). Patients in the verum group will receive
 fluvastatin in a starting dose of 40 mg per day. The dose should be increased up to 80 mg per
 day. The treatment should be continued until the study end (24 months). Follow up
 investigations will be performed after 6, 12, and 18 months. After 24 months the final
 investigations will be performed.
Inclusion Criteria:

 1. Age ≥ 21 years

 2. Mild to moderate aortic stenosis

 3. No symptoms caused by aortic stenosis

 4. Written informed consent to participate in the study

 5. Aortic valve leaflet thickening with reduced systolic opening

 6. Reduced aortic valve area > 0,8 cm2 and < 1,5 cm2

 7. Maximum aortic jet velocity at rest > 2,5 m/s

 Exclusion Criteria:

 1. Symptoms caused by aortic stenosis

 2. Aortic valve area < 0,7 cm2

 3. Severe aortic regurgitation

 4. Reduced left ventricular ejection fraction (< 50%)

 5. Any valve disease with indication for surgery

 6. Coronary artery disease

 7. Therapy refractory arterial hypertension

 8. Comorbid noncardiac diseases or other reasons which make a regular follow-up
 impossible

 9. Other indication for treatment with statins

 10. Women of childbearing potential not using the contraception method(s) specified in
 this study (specify), as well as women who are breastfeeding

 11. Known sensitivity to study drug(s) or class of study drug(s)

 12. Patients with severe medical condition(s) that in the view of the investigator
 prohibits participation in the study (specify as required)

 13. Use of any other investigational agent in the last 30 days