Effect of cholesterol lowering on progression of aortic stenosis in patients with mild to moderate aortic stenosis

Completed

• Conditions: Aortic stenosis (AS); Circulatory System; Nonrheumatic aortic valve disorders

• Registration Number: ISRCTN32424163
• Lead Sponsor: niversity of Ottawa (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 264

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in peak transvalvular aortic velocity, transvalvular gradients and aortic valve area

Secondary Outcome Measures

Name	Time	Method
1. Cardiac death measured at the end of three years of follow-up<br>2. Aortic valve replacement