Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis.

• Status: Terminated
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AORTICA Group
• Treatments: Fluvastatin

Criteria

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