Rosuvastatin Affecting Aortic Valve Endothelium

Atherosclerosis Clinical Trial

Official title:

Rosuvastatin Affecting Aortic Valve Endothelium - RAAVE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114491
• Other study ID #: 22352
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2005
• Last updated: October 30, 2006
• Start date: September 2003
• Est. completion date: May 2005

Study information

• Verified date: October 2006
• Source: Hospital Pedro Hispano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: National Pharmacy and Medicines Institute
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Atherosclerosis
• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin

Locations

Country	Name	City	State
Portugal	Hospital Pedro Hispano	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Pedro Hispano	Northwestern University

Country where clinical trial is conducted

Portugal, 

References & Publications (7)

Makkena B, Salti H, Subramaniam M, Thennapan S, Bonow RH, Caira F, Bonow RO, Spelsberg TC, Rajamannan NM. Atorvastatin decreases cellular proliferation and bone matrix expression in the hypercholesterolemic mitral valve. J Am Coll Cardiol. 2005 Feb 15;45( — View Citation

Otto CM. Why is aortic sclerosis associated with adverse clinical outcomes? J Am Coll Cardiol. 2004 Jan 21;43(2):176-8. — View Citation

Rajamannan NM, Edwards WD, Spelsberg TC. Hypercholesterolemic aortic-valve disease. N Engl J Med. 2003 Aug 14;349(7):717-8. — View Citation

Rajamannan NM, Otto CM. Targeted therapy to prevent progression of calcific aortic stenosis. Circulation. 2004 Sep 7;110(10):1180-2. — View Citation

Rajamannan NM, Subramaniam M, Rickard D, Stock SR, Donovan J, Springett M, Orszulak T, Fullerton DA, Tajik AJ, Bonow RO, Spelsberg T. Human aortic valve calcification is associated with an osteoblast phenotype. Circulation. 2003 May 6;107(17):2181-4. Epub — View Citation

Rajamannan NM, Subramaniam M, Stock SR, Stone NJ, Springett M, Ignatiev KI, McConnell JP, Singh RJ, Bonow RO, Spelsberg TC. Atorvastatin inhibits calcification and enhances nitric oxide synthase production in the hypercholesterolaemic aortic valve. Heart. — View Citation

Rajamannan NM. Is it time for medical therapy for aortic valve disease? Expert Rev Cardiovasc Ther. 2004 Nov;2(6):845-54. — View Citation