Rosuvastatin Affecting Aortic Valve Endothelium

October 30, 2006 updated by: Hospital Pedro Hispano

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal
        • Hospital Pedro Hispano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Defined Population
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Pedro Hispano

Collaborators

Northwestern University

Investigators

  • Principal Investigator: Luis M Moura, Hospital Pedro Hispano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

June 15, 2005

First Submitted That Met QC Criteria

June 15, 2005

First Posted (Estimate)

June 16, 2005

Study Record Updates

Last Update Posted (Estimate)

October 31, 2006

Last Update Submitted That Met QC Criteria

October 30, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22352

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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