Status:
TERMINATED
Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis.
Lead Sponsor:
AORTICA Group
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Atherosclerosis and aortic stenosis share inflammatory etiopathogenic characteristics in common. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients wit...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Asymptomatic
- Aortic stenosis defined as aortic valve leaflet thickening with reduced systolic opening (maximum aortic jet velocity \>2 m/s)
- Written informed consent to participate in the study
- Patients capable to follow all conditions along the study.
Exclusion
- Symptomatic patients caused by aortic stenosis.
- Patients on statins anytime in the year before inclusion.
- Patients diagnosed of dyslipidemia requiring statins.
- Temperature ³37,8 ºC in the week before inclusion.
- Any cardiovascular event succeeding in the three months before inclusion
- Known thyrotoxicosis
- Renal failure requiring hemodialysis
- Any inflammatory noncardiac diseases or other reasons known to influence the study biomarkers concentrations.
- Any surgery succeeding in the three months before inclusion.
- Patients with any hepatopathy that in the view of the investigator prohibits participation in the study.
- Patients with known muscular disease.
- Patients with any severe medical condition that in the view of the investigator prohibits participation in the study
- Use of corticoids, immunosuppressors or non steroid drugs.
- Any known sensitivity to study drug (fluvastatin) or class of study drug.
- Patients participating in any study in the last year.
- Women of childbearing potential not using the contraception method(s) specified in this study, suspicion of pregnancy, as well as women who are breastfeeding
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00404287
Start Date
October 1 2006
End Date
January 1 2018
Last Update
June 7 2019
Active Locations (1)
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1
Hospital Universitario de Salamanca
Salamanca, Spain, 37002