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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Atorvastatin 80 mg. | Experimental | Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement. |
|
| 2: No Atrovastatine | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 80 mg | Drug | Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel KINDO, MD | Contact | 33.3.69.55.08.11 | michel.kindo@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Michel KINDO, MD | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Cardio-VasculaireHôpital Civil | Recruiting | Strasbourg | 67 091 | France |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D014694 |
| Ventricular Outflow Obstruction |
| D006332 | Cardiomegaly |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |