Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176410
Status:
UNKNOWN
Last Update Posted:
2010-01-14
First Post:
2005-09-13
Brief Title:
Statin Therapy in Asymptomatic Aortic Stenosis
Sponsor:
University of Leipzig
Organization:
University of Leipzig
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None