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Rosuvastatin Affecting Aortic Valve Endothelium

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114491
First Posted: June 16, 2005
Last Update Posted: October 31, 2006
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.
Collaborator:
Northwestern University
Information provided by:
Hospital Pedro Hispano
  Purpose
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00114491     History of Changes
Other Study ID Numbers: 22352
First Submitted: June 15, 2005
First Posted: June 16, 2005
Last Update Posted: October 31, 2006
Last Verified: October 2006

Keywords provided by Hospital Pedro Hispano:
Aortic Stenosis
Statins
Hypercholesterolemia

Additional relevant MeSH terms:
Atherosclerosis
Hypercholesterolemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors