NCT00114491

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2005

Completed
Last Updated

October 31, 2006

Status Verified

October 1, 2006

First QC Date

June 15, 2005

Last Update Submit

October 30, 2006

Conditions

AtherosclerosisHypercholesterolemia

Keywords

Aortic StenosisStatinsHypercholesterolemia

Interventions

RosuvastatinDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic AS
  • Normal ejection fraction
  • Elevated LDL \>130 mg/dl

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Pedro Hispano

Porto, Portugal

Location

Related Publications (8)

  • 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. doi: 10.1136/hrt.2003.029785.

    PMID: 15894785RESULT

  • 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. doi: 10.1016/j.jacc.2004.11.023. No abstract available.

    PMID: 15708716RESULT

  • Rajamannan NM. Is it time for medical therapy for aortic valve disease? Expert Rev Cardiovasc Ther. 2004 Nov;2(6):845-54. doi: 10.1586/14779072.2.6.845.

    PMID: 15500430RESULT

  • Rajamannan NM, Edwards WD, Spelsberg TC. Hypercholesterolemic aortic-valve disease. N Engl J Med. 2003 Aug 14;349(7):717-8. doi: 10.1056/NEJMc031360. No abstract available.

    PMID: 12917318RESULT

  • Otto CM. Why is aortic sclerosis associated with adverse clinical outcomes? J Am Coll Cardiol. 2004 Jan 21;43(2):176-8. doi: 10.1016/j.jacc.2003.10.027. No abstract available.

    PMID: 14736433RESULT

  • Rajamannan NM, Otto CM. Targeted therapy to prevent progression of calcific aortic stenosis. Circulation. 2004 Sep 7;110(10):1180-2. doi: 10.1161/01.CIR.0000140722.85490.EA. No abstract available.

    PMID: 15353511RESULT

  • 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. doi: 10.1161/01.CIR.0000070591.21548.69. Epub 2003 Apr 28.

    PMID: 12719282RESULT

  • 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. doi: 10.1016/j.jacc.2006.07.072. Epub 2007 Jan 22.

    PMID: 17276178DERIVED

MeSH Terms

Conditions

AtherosclerosisHypercholesterolemiaAortic Valve Stenosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Luis M Moura

    Hospital Pedro Hispano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2005

First Posted

June 16, 2005

Study Start

September 1, 2003

Study Completion

May 1, 2005

Last Updated

October 31, 2006

Record last verified: 2006-10

Locations

PT(1)