Aortic valve stenosis, congenital heart defects
Conditions
Interventions
After completion of all baseline investigations (echocardiography, MRI and venous blood collection) patients will be randomly assigned to the statin group or to the placebo group. Patients in the stat
Sponsors
Erasmus Medical Center, Rotterdam, Department of Cardiology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Valvular congenital aortic stenosis with a maximum aortic jet velocity > 2.5 m/s; 2. Age 18-45 years.
Exclusion criteria
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 3 x upper limit of normal (>600 U/L); 12. Renal impairment (creatinin > 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 ciclosporin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of aortic stenosis measured by transthoracic echocardiography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression of aortic dilatation and development of left ventricular hypertrophy measured by MRI and transthoracic echocardiography. | — |
Contacts
Public ContactJ.W. Roos-Hesselink
Erasmus Medical Center, Department of Cardiology, P.O. Box 2040
Outcome results
None listed