Aortic stenosis (AS) Circulatory System Nonrheumatic aortic valve disorders
Conditions
Interventions
Rosuvastatin 40 mg daily versus placebo
Sponsors
University of Ottawa (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 82 years 2. Both men and women will be included 3. At least mild AS defined by peak Doppler aortic valve velocity = 2.5 m/sec 4. Moderate risk for coronary artery disease (CAD), with low density lipoprotein cholesterol (LDL-C) less than 4 mmol/l and total cholesterol: high density lipoprotein cholesterol (HDL-C) ratio less than 6 5. Low risk for CAD with LDL-C less than 5 mmol/l and total cholesterol: HDL-C less than 7
Exclusion criteria
Exclusion criteria: 1. Peak Doppler aortic valve velocity less than 2.5 m/sec, because of the rate of progression in these patients is not well defined 2. Severe AS (a mean aortic gradient = 40 mmHg or AVA = 0.9 cm^2). These patients are excluded because they will have a high probability of aortic valve replacement even without further AS progression. 3. Symptomatic AS 4. Greater than moderate aortic regurgitation 5. Patients with significant concomitant mitral valve disease, defined by greater than moderate MR or MVA less than 2.0 cm^2 6. Patients on cholesterol lowering agents 7. Symptomatic coronary artery disease 8. Diabetes mellitus either on oral agent or insulin 9. At high or very high risks for CAD (10 year risk greater than 20%) 10. Moderate risk for CAD, but LDL-C greater than 4 mmol/l or total cholesterol: HDL-C ratio greater than 6 11. Low risk for CAD, but LDL-C greater than 5 mmol/l or total cholesterol: HDL-C ratio greater than 7 12. Pregnant or lactating women 13. Inability to return for follow up visits 14. Concomitant medical conditions, which limit the survival in the next 5 years 15. Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in peak transvalvular aortic velocity, transvalvular gradients and aortic valve area | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cardiac death measured at the end of three years of follow-up 2. Aortic valve replacement | — |
Countries
Canada
Outcome results
None listed