Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

Study Overview
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Brief Summary
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The purpose of the study is to see if statin therapy will optimize myocardial response to cardiopulmonary bypass during aortic valve replacement (AVR) for aortic valve stenosis (AVS) (Phase I) and optimize left ventricular reverse remodeling following AVR (Phase II). Preliminary evidence indicates that perioperative statin therapy reduce mortality and morbidity following cardiac surgery. Pleiotropic effects of statins may induce myocardial preconditioning and optimize myocardial and systemic responses to cardiopulmonary bypass during AVR. Furthermore statin therapy after AVR may contribute to an optimal left ventricular reverse remodeling.

Official Title
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Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.

Conditions
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Aortic Valve Stenosis, Ventricular Hypertrophy

Intervention / Treatment
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* Drug: Atorvastatin 80 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > or = 70 years and < 80 years Severe aortic valve stenosis Indication for aortic valve replacement by bioprothesis Ejection fraction > or = 50% Without treatment with statin- No renal failure Informed consent signed Exclusion Criteria: Ischemic heart disaese Concomitant surgery to aortic valve replacement Emergency surgery- Known intolerance for statin Pregnant woman

Ages Eligible for Study
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Minimum Age: 70 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Atorvastatin 80 mg.<br>Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement. | Drug: Atorvastatin 80 mg<br>* Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.<br>|
| No Intervention: 2: No Atrovastatine<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ♦ Phase I: To study changes on inflammatory markers after aortic valve replacement. ♦ Phase II: To study changes in left ventricular mass at the end of the study (12 months). |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: To study changes on mitochondrial function, reactive oxygen species, and perioperative systolic and diastolic functions. Phase II: To study changes on clinical status, systolic and diastolic functions during the one-year follow-up. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left ventricular hypertrophy, Aortic valve stenosis, Aortic valve replacement, Cardiopulmonary bypass, Statins, Myocardial preconditioning, Left ventricular reverse remodeling