Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114491
Status:
COMPLETED
Last Update Posted:
2006-10-31
First Post:
2005-06-15
Brief Title:
Rosuvastatin Affecting Aortic Valve Endothelium
Sponsor:
Hospital Pedro Hispano
Organization:
Hospital Pedro Hispano
Study Overview
Official Title:
Rosuvastatin Affecting Aortic Valve Endothelium - RAAVE
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
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:
Recent studies support the hypothesis that aortic stenosis AS develops due to atherosclerosis affecting the aortic valve endothelium The studys aim was to assess Rosuvastatin on the hemodynamic progression and inflammatory markers of AS by treating low-density lipoprotein LDL in patients with AS according to the National Cholesterol Education Program Adult Treatment Panel III NCEP-ATPIII guidelines for one year
Detailed Description:
Background Recent retrospective studies support the hypothesis that statins slow the progression of aortic stenosis The aim of this study was to assess the effect of Rosuvastatin on hemodynamic progression of aortic stenosis by treating patients with aortic stenosis and elevated LDL-cholesterol for 18 months
Methods We performed an open-label prospective study evaluating 121 consecutive patients with asymptomatic moderate to severe aortic stenosis AVA 10 cm2 mean age 73789 years 57 men and 64 women treated with and without Rosuvastatin according to the NCEP-ATPIII guidelines Echocardiographic serum lipid and inflammatory markers were measured at baseline and every 6 months for 18 months
Methods We performed an open-label prospective study evaluating 121 consecutive patients with asymptomatic moderate to severe aortic stenosis AVA 10 cm2 mean age 73789 years 57 men and 64 women treated with and without Rosuvastatin according to the NCEP-ATPIII guidelines Echocardiographic serum lipid and inflammatory markers were measured at baseline and every 6 months for 18 months
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