TerminatedPhase 4

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

Stopped: Funding not enough to complete the study

Spain164 participantsStarted 2006-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

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

Timeframe: 12 months

Trial details

NCT IDNCT00404287

SponsorAORTICA Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11-01

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