Effect of cholesterol lowering on progression of aortic stenosis in patients with mild to moderate aortic stenosis
| ISRCTN | ISRCTN32424163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32424163 |
| Secondary identifying numbers | DCT-42878 |
- Submission date
- 05/09/2005
- Registration date
- 05/09/2005
- Last edited
- 06/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kwan-Leung Chan
Scientific
Scientific
Dr. K. L. Chan & Adult Congenital Heart Clinic
Room 3411
University of Ottawa Heart Institute
40 Ruskin Street
Ottawa
K1Y 4W7
Canada
| Phone | +1 613 761 4189 |
|---|---|
| kchan@ottawaheart.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Effect of cholesterol lowering on progression of aortic stenosis in patients with mild to moderate aortic stenosis: a randomised controlled trial |
| Study acronym | ASTRONOMER |
| Study objectives | Primary hypothesis is that patients taking a statin will experience a smaller increase in aortic transvalvular gradients and a smaller decrease in aortic valve area than patients taking placebo over a three-year follow-up period. Secondary hypotheses are that: 1. The event rate (cardiac death and aortic valve replacement) at the end of three years will be lower 2. The time to outcome events is longer in patients taking a statin than in patients taking placebo |
| Ethics approval(s) | University of Ottawa Heart Institute Ethics Committee gave approval on the 3rd October 2002. |
| Health condition(s) or problem(s) studied | Aortic stenosis (AS) |
| Intervention | Rosuvastatin 40 mg daily versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Rosuvastatin |
| Primary outcome measure | Changes in peak transvalvular aortic velocity, transvalvular gradients and aortic valve area |
| Secondary outcome measures | 1. Cardiac death measured at the end of three years of follow-up 2. Aortic valve replacement |
| Overall study start date | 01/12/2002 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 264 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2002 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
Dr. K. L. Chan & Adult Congenital Heart Clinic
Ottawa
K1Y 4W7
Canada
K1Y 4W7
Canada
Sponsor information
University of Ottawa (Canada)
Not defined
Not defined
451 Smyth Road
P.O. Box 450
Station A
Ottawa
K1N 6N5
Canada
| Website | http://www.uottawa.ca/ |
|---|---|
"ROR" |
https://ror.org/03c4mmv16 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-42878)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | trial design | 01/06/2007 | Yes | No | |
| Results article | results | 19/01/2010 | Yes | No |
