Rosuvastatin Affecting Aortic Valve Endothelium

Completed

• Conditions: Atherosclerosis; Hypercholesterolemia

• Registration Number: NCT00114491
• Lead Sponsor: Hospital Pedro Hispano

Brief Summary

Recent studies support the hypothesis that aortic stenosis (AS) develops due to atherosclerosis affecting the aortic valve endothelium. The study's 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≥ 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 Timeline

• Study Start: 2003-09
• Study Completion: 2005-05
• Study First Submitted: 2005-06-15
• Study First Submitted QC: 2005-06-15
• Study First Posted: 2005-06-16
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-30
• Last Update Posted: 2006-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Asymptomatic AS
• Normal ejection fraction
• Elevated LDL >130 mg/dl

Exclusion Criteria

• Echocardiographic evidence of rheumatic mitral valve disease,
• Previous statin therapy,
• Congenital heart disease (bicuspid aortic valve),
• Subaortic obstruction,
• Creatinine ≥ 2,0 mg/dl (to avoid the potential confounder of an elevated serum [CaP04]),
• Evidence of liver disease,
• Greater than mild aortic regurgitation and previous aortic valve surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Hospital Pedro Hispano; 🇵🇹 Porto, Portugal