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

AORTICA Group

Status and phase: Terminated; Phase 4

Conditions: Aortic Valve Stenosis

Treatments: Drug: Fluvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00404287

EudraCT number 2005-003666-42

CXUO320BES04

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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164 participants in 2 patient groups, including a placebo group

fluvastatin

Active Comparator group

Description:

fluvastatin 80 mg

Treatment:

Drug: Fluvastatin

placebo

Placebo Comparator group

Treatment:

Drug: Fluvastatin