Official Title: “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.”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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).

Intervention(s) in this Clinical Trial

• Drug: Fluvastatin

Primary Measures

• To study changes in CRP (mg/dL) concentration at the end of the study (12 months)

Secondary Measures

• To study changes in other inflammatory biomarkers (specify in the protocol) at the end of the study (12 months)
• To study changes in these biomarkers in the different grades of aortic stenosis at the end of the study (12 months)
• To study changes change in aortic valve area and medium aortic transvalvular gradient at the end of the study (12 months)
• To study the safety and tolerability of fluvastatin in patients with aortic stenosis.

Inclusion Criteria:

• 1. Age ≥ 18 years
• 2. Asymptomatic
• 3. Aortic stenosis defined as aortic valve leaflet thickening with reduced systolic opening (maximum aortic jet velocity >2 m/s)
• 4. Written informed consent to participate in the study
• 5. Patients capable to follow all conditions along the study.

Exclusion Criteria:

• 1. Symptomatic patients caused by aortic stenosis.
• 2. Patients on statins anytime in the year before inclusion.
• 3. Patients diagnosed of dyslipidemia requiring statins.
• 4. Temperature ³37,8 ºC in the week before inclusion.
• 5. Any cardiovascular event succeeding in the three months before inclusion
• 6. Known thyrotoxicosis
• 7. Renal failure requiring hemodialysis
• 8. Any inflammatory noncardiac diseases or other reasons known to influence the study biomarkers concentrations.
• 9. Any surgery succeeding in the three months before inclusion.
• 10. Patients with any hepatopathy that in the view of the investigator prohibits participation in the study.
• 11. Patients with known muscular disease.
• 12. Patients with any severe medical condition that in the view of the investigator prohibits participation in the study
• 13. Use of corticoids, immunosuppressors or non steroid drugs.
• 14. Any known sensitivity to study drug (fluvastatin) or class of study drug.
• 15. Patients participating in any study in the last year.
• 16. Women of childbearing potential not using the contraception method(s) specified in this study, suspicion of pregnancy, as well as women who are breastfeeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AORTICA Group

Overall Clinical Trial Officials and Contacts

Pedro L Sanchez, MD, PhD Principal Investigator Hospital Universitario Gregorio Marañón de Madrid  

Overall Contact: Pedro L Sanchez, MD, PhD 34-637971999 pedrolsanchez@secardiologia.es

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00404287

Study ID Number: CXUO320BES04

ClinicalTrials.gov Identifier: NCT00404287

Health Authority: Spain: Spanish Agency of Medicines