Rosuvastatin Affecting Aortic Valve Endothelium - Full Text View

Sponsors and Collaborators:	Hospital Pedro Hispano Northwestern University
Information provided by:	Hospital Pedro Hispano
ClinicalTrials.gov Identifier:	NCT00114491

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 IV

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

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

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

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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 of Results:

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. 2005 Jun;91(6):806-10.

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(4):631-3. No abstract available.

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

Rajamannan NM, Edwards WD, Spelsberg TC. Hypercholesterolemic aortic-valve disease. N Engl J Med. 2003 Aug 14;349(7):717-8. No abstract available.

Otto CM. Why is aortic sclerosis associated with adverse clinical outcomes? J Am Coll Cardiol. 2004 Jan 21;43(2):176-8. No abstract available.

Rajamannan NM, Otto CM. Targeted therapy to prevent progression of calcific aortic stenosis. Circulation. 2004 Sep 7;110(10):1180-2. No abstract available.

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 2003 Apr 28.

Publications indexed to this study:

Moura LM, Ramos SF, Zamorano JL, Barros IM, Azevedo LF, Rocha-Goncalves F, Rajamannan NM. Rosuvastatin affecting aortic valve endothelium to slow the progression of aortic stenosis. J Am Coll Cardiol. 2007 Feb 6;49(5):554-61. Epub 2007 Jan 22.

Study ID Numbers:	22352
Study First Received:	June 15, 2005
Last Updated:	October 30, 2006
ClinicalTrials.gov Identifier:	NCT00114491
Health Authority:	Portugal: National Pharmacy and Medicines Institute

Keywords provided by Hospital Pedro Hispano:

Aortic Stenosis
Statins
Hypercholesterolemia

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Hyperlipidemias
Metabolic Diseases
Vascular Diseases
Constriction, Pathologic
Arteriosclerosis

Aortic valve stenosis
Rosuvastatin
Aortic Valve Stenosis
Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009