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Rosuvastatin Affecting Aortic Valve Endothelium

This study has been completed.
Northwestern University
Information provided by:
Hospital Pedro Hispano Identifier:
First received: June 15, 2005
Last updated: October 30, 2006
Last verified: October 2006
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 Intervention Phase
Atherosclerosis Hypercholesterolemia Drug: Rosuvastatin Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Rosuvastatin Affecting Aortic Valve Endothelium - RAAVE

Resource links provided by NLM:

Further study details as provided by Hospital Pedro Hispano:

Estimated Enrollment: 200
Study Start Date: September 2003
Estimated Study Completion Date: May 2005
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.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00114491

Hospital Pedro Hispano
Porto, Portugal
Sponsors and Collaborators
Hospital Pedro Hispano
Northwestern University
Principal Investigator: Luis M Moura Hospital Pedro Hispano
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00114491     History of Changes
Other Study ID Numbers: 22352
Study First Received: June 15, 2005
Last Updated: October 30, 2006

Keywords provided by Hospital Pedro Hispano:
Aortic Stenosis

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on September 21, 2017