Contact information
Type
Scientific
Primary contact
Dr Kwan-Leung Chan
ORCID ID
Contact details
Dr. K. L. Chan & Adult Congenital Heart Clinic
Room 3411
University of Ottawa Heart Institute
40 Ruskin Street
Ottawa
K1Y 4W7
Canada
+1 613 761 4189
kchan@ottawaheart.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DCT-42878
Study information
Scientific title
Effect of cholesterol lowering on progression of aortic stenosis in patients with mild to moderate aortic stenosis: a randomised controlled trial
Acronym
ASTRONOMER
Study hypothesis
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
University of Ottawa Heart Institute Ethics Committee gave approval on the 3rd October 2002.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Aortic stenosis (AS)
Intervention
Rosuvastatin 40 mg daily versus placebo
Intervention type
Drug
Phase
Not Applicable
Drug names
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 trial start date
01/12/2002
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
264
Participant 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
Recruitment start date
01/12/2002
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Canada
Trial participating centre
Dr. K. L. Chan & Adult Congenital Heart Clinic
Ottawa
K1Y 4W7
Canada
Sponsor information
Organisation
University of Ottawa (Canada)
Sponsor details
451 Smyth Road
P.O. Box 450
Station A
Ottawa
K1N 6N5
Canada
Sponsor type
Not defined
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-42878)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 trial design in http://www.ncbi.nlm.nih.gov/pubmed/17540192
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20048204
Publication citations
-
Results
Chan KL, Teo K, Dumesnil JG, Ni A, Tam J, , Effect of Lipid lowering with rosuvastatin on progression of aortic stenosis: results of the aortic stenosis progression observation: measuring effects of rosuvastatin (ASTRONOMER) trial., Circulation, 2010, 121, 2, 306-314, doi: 10.1161/CIRCULATIONAHA.109.900027.
-
Chan KL, Teo K, Tam J, Dumesnil JG, , Rationale, design, and baseline characteristics of a randomized trial to assess the effect of cholesterol lowering on the progression of aortic stenosis: the Aortic Stenosis Progression Observation: Measuring Effects of Rosuvastatin (ASTRONOMER) trial., Am. Heart J., 2007, 153, 6, 925-931, doi: 10.1016/j.ahj.2007.03.011.