Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

University Hospital, Strasbourg, France60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Aortic Valve Stenosis Ventricular Hypertrophy

Interventions

Eligibility

Sex: ALLMin age: 70 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

♦ 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).

Time frame: 1 year

Secondary Outcomes

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.