Clinical Trial: Statin Therapy in Asymptomatic Aortic Stenosis

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title:

Brief Summary: There is evidence that the degenerative changes leading to aortic stenosis are caused by a chronic inflammatory process. Furthermore the development of aortic stenosis is partially dependent on typical cardiovascular risk factors. An inflammatory process as well as those risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase inhibitors) would be an appealing concept to reduce both those risks for development of aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the progression of aortic stenosis.

Detailed Summary: This study will be a prospective, double-blind, placebo-controlled, two-armed clinical trial trial to test the influence of statin therapy on the progression of calcified aortic stenosis in patients with asymptomatic mild to moderate aortic stenosis. After completion of all baseline investigations patients will be randomly assigned to the verum group (fluvastatin group) or to the control group (placebo group). Patients in the verum group will receive fluvastatin in a starting dose of 40 mg per day. The dose should be increased up to 80 mg per day. The treatment should be continued until the study end (24 months). Follow up investigations will be performed after 6, 12, and 18 months. After 24 months the final investigations will be performed.
Sponsor: University of Leipzig

Current Primary Outcome:

  • Progression of calcified aortic stenosis measured by: [ Time Frame: 24 months ]
  • Transthoracic echocardiography (P max/ mean; V max; AVA) [ Time Frame: 24 months ]
  • Catheterization (peak to peak gradient, LV-function, compliance) [ Time Frame: 24 months ]


Original Primary Outcome:

  • Progression of clacific aortic stenosis measured by:
  • Transthoracic echocardiography (P max/ mean; V max; AVA)
  • Catheterization (peak to peak gradient, LV-function, compliance)


Current Secondary Outcome: Number of cardiovascular events [ Time Frame: 24 months ]

Original Secondary Outcome: Number of cardiovascular events

Information By: University of Leipzig

Dates:
Date Received: September 13, 2005
Date Started: January 2003
Date Completion: December 2009
Last Updated: January 13, 2010
Last Verified: September 2006