Aortic Stenosis
Conditions
Keywords
progression of aortic stenosis
Brief summary
The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year recruitment period, and a treatment duration of a minimum of 3 years from the time of the last patient randomized to a maximum of 5 years.
Interventions
DRUGRosuvastatin
40 mg, oral, single dose
DRUGPlacebo
oral, single dose
Sponsors
Ottawa Heart Institute Research Corporation
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate AS defined by peak Doppler aortic valve velocity 2.5 to 4 m/sec * Baseline LDL-C value must be within targeted level for all risk categories according to the Canadian Guidelines * Baseline triglyceride levels must be within target level for the risk categories
Exclusion criteria
* Very mild AS defined by peak Doppler AS velocity \<2.5m/sec, because the rate of progression is not well defined; Females of child bearing potential who do not practice adequate contraception. * Severe AS defined by peak Doppler AS velocity \> 4m/sec. These patients are excluded because they will have a high probability of aortic valve replacement even without further AS progression. * Greater than moderate aortic regurgitation, defined as aortic jet width to aortic outflow tract ratio \>0.45; Patients with diabetes or with a fasting blood sugar level \> 7.0 mmol/L (must be confirmed with one repeat assay within 14 days). * Significant concomitant mitral valve disease, defined by \> moderate mitral regurgitation (MR) or mitral valve area (MVA)\< 1.5 cm2; A very high risk of CAD (10 year risk \> 30%), according to the Canadian Guidelines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in transvalvular aortic velocities and the changes in aortic valve area. | Between baseline and close-out measurments. |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups. | Baseline and minimum of 3 year follow-up. |
Countries
Canada
Outcome results
None listed