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

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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).
Sponsor: AORTICA Group

Current Primary Outcome: To study changes in CRP (mg/dL) concentration at the end of the study (12 months) [ Time Frame: 12 months ]

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

Current Secondary Outcome:

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


Original Secondary Outcome:

  • 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.


Information By: AORTICA Group

Dates:
Date Received: November 27, 2006
Date Started: October 2006
Date Completion: November 2014
Last Updated: October 13, 2014
Last Verified: October 2014