Prospective Randomized Trial of the Effects of Rosuvastatin on the Progression of Stenosis in Adult Patients with Congenital Aortic Stenosis

Completed

• Conditions: Aortic valve stenosis, congenital heart defects; Circulatory System; Congenital malformations of aortic and mitral valves

• Registration Number: ISRCTN56552248
• Lead Sponsor: Erasmus Medical Center, Department of Cardiology (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Valvular congenital aortic stenosis with a maximum aortic jet velocity >2.5 m/s
2. Age 18-45 years

Exclusion Criteria

1. Use of statins or other study medication
2. Subvalvular or supravalvular aortic stenosis
3. Aortic regurgitation >2+
4. Malignancy within last 2 years
5. Aortic valve replacement in past
6. Rheumatic fever in past
7. Significant concomitant mitral valve disease (MR >2+ or MVA <1.5 cm2)
8. History of HMG-CoA reductase inhibitor hypersensitivity
9. Active liver disease
10. Muscular/neuromuscular disease
11. CPK >3 x upper limit of normal (>600 U/l)
12. Renal impairment (creatinine >200 umol/l)
13. Women contemplating pregnancy within next 5 years
14. Pregnant/breast-feeding women
15. Women of childbearing potential not using appropriate contraception
16. Use of cyclosporine

Study & Design

• Study Type: Interventional
• Study Design: Not specified