Statin Therapy in Asymptomatic Aortic Stenosis

Study Overview
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Brief Summary
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There is evidence that the degenerative changes leading to aortic stenosis are caused by a chronic inflammatory process. Furthermore the development of aortic stenosis is partially dependent on typical cardiovascular risk factors. An inflammatory process as well as those risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase inhibitors) would be an appealing concept to reduce both those risks for development of aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the progression of aortic stenosis.

Detailed Description
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This study will be a prospective, double-blind, placebo-controlled, two-armed clinical trial trial to test the influence of statin therapy on the progression of calcified aortic stenosis in patients with asymptomatic mild to moderate aortic stenosis. After completion of all baseline investigations patients will be randomly assigned to the verum group (fluvastatin group) or to the control group (placebo group). Patients in the verum group will receive fluvastatin in a starting dose of 40 mg per day. The dose should be increased up to 80 mg per day. The treatment should be continued until the study end (24 months). Follow up investigations will be performed after 6, 12, and 18 months. After 24 months the final investigations will be performed.

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Drug: fluvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 21 years Mild to moderate aortic stenosis No symptoms caused by aortic stenosis Written informed consent to participate in the study Aortic valve leaflet thickening with reduced systolic opening Reduced aortic valve area > 0,8 cm2 and < 1,5 cm2 Maximum aortic jet velocity at rest > 2,5 m/s Exclusion Criteria: Symptoms caused by aortic stenosis Aortic valve area < 0,7 cm2 Severe aortic regurgitation Reduced left ventricular ejection fraction (< 50%) Any valve disease with indication for surgery Coronary artery disease Therapy refractory arterial hypertension Comorbid noncardiac diseases or other reasons which make a regular follow-up impossible Other indication for treatment with statins Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding Known sensitivity to study drug(s) or class of study drug(s) Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required) Use of any other investigational agent in the last 30 days

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluvastatin|40mg fluvastatin daily|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of calcified aortic stenosis measured by: |  | 24 months | 
| Transthoracic echocardiography (P max/ mean; V max; AVA) |  | 24 months | 
| Catheterization (peak to peak gradient, LV-function, compliance) |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cardiovascular events |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve stenosis, statin therapy