Rosuvastatin Affecting Aortic Valve Endothelium

This study has been completed.
Sponsor:
Collaborator:
Northwestern University
Information provided by:
Hospital Pedro Hispano
ClinicalTrials.gov Identifier:
NCT00114491
First received: June 15, 2005
Last updated: October 30, 2006
Last verified: October 2006

June 15, 2005
October 30, 2006
September 2003
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Complete list of historical versions of study NCT00114491 on ClinicalTrials.gov Archive Site
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Rosuvastatin Affecting Aortic Valve Endothelium
Rosuvastatin Affecting Aortic Valve Endothelium - RAAVE

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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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  • Atherosclerosis
  • Hypercholesterolemia
Drug: Rosuvastatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 2005
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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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT00114491
22352
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Hospital Pedro Hispano
Northwestern University
Principal Investigator: Luis M Moura Hospital Pedro Hispano
Hospital Pedro Hispano
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP