Effects of Rosuvastatin on Aortic Stenosis Progression

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Cholesterol Lowering on the Progression of Aortic Stenosis in Patients With Mild to Moderate Aortic Stenosis (ASTRONOMER)Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin and The Sub-Study Protocol.

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Rosuvastatin 40 mg | Drug: Rosuvastatin<br>* 40 mg, oral, single dose<br>|
| Placebo Comparator: 2<br>placebo | Drug: Placebo<br>* oral, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in transvalvular aortic velocities and the changes in aortic valve area. |  | Between baseline and close-out measurments. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 
| The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups. |  | Between baseline and close-out measurments. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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progression of aortic stenosis