Rosuvastatin Affecting Aortic Valve Endothelium
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00114491|
Recruitment Status : Completed
First Posted : June 16, 2005
Last Update Posted : October 31, 2006
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis Hypercholesterolemia||Drug: Rosuvastatin||Phase 4|
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≥ 1.0 cm2), (mean age 73.7±8.9 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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Rosuvastatin Affecting Aortic Valve Endothelium - RAAVE|
|Study Start Date :||September 2003|
|Estimated Study Completion Date :||May 2005|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114491
|Hospital Pedro Hispano|
|Principal Investigator:||Luis M Moura||Hospital Pedro Hispano|