Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

University Hospital, Strasbourg, France

Status and phase: Unknown; Phase 3

Conditions: Aortic Valve Stenosis; Ventricular Hypertrophy

Treatments: Drug: Atorvastatin 80 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00811330

3963

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 70 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

1: Atorvastatin 80 mg.

Experimental group

Description:

Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.

Treatment:

Drug: Atorvastatin 80 mg

2: No Atrovastatine

No Intervention group