Rosuvastatin Affecting Aortic Valve Endothelium

Sponsor

Hospital Pedro Hispano (Other)

Overall Status

Completed

CT.gov ID

NCT00114491

Collaborator

Northwestern University (Other)

200

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Hypercholesterolemia	Drug: Rosuvastatin

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 Design

Study Type:

Observational

Observational Model:

Defined Population

Time Perspective:

Prospective

Official Title:

Rosuvastatin Affecting Aortic Valve Endothelium - RAAVE

Study Start Date :

Sep 1, 2003

Study Completion Date :

May 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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