Kindo 2008.

Trial name or title	Interest of statin in surgical aortic stenosis: from myocardial preconditioning to ventricular reverse remodeling
Methods	Randomised controlled trial. Allocation: Randomised. Endpoint Classification: Efficacy study. Intervention Model: Parallel assignment. Masking: Single‐blind (participant). Primary Purpose: Treatment. Phase: 3.
Participants	Inclusion Criteria: 1. Age > or = 70 years and < 80 years. 2. Severe aortic valve stenosis. 3. Indication for aortic valve replacement by bioprosthesis. 4. Ejection fraction > or = 50%. 5. Without treatment with statin and no renal failure. 6. Informed consent signed. Exclusion Criteria: 1. Ischemic heart disease. 2. Concomitant surgery to aortic valve replacement. 3. Emergency surgery and known intolerance for statin. 4. Pregnant woman.
Interventions	Atorvastatin 80 mg per day.
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 ] [ Designated as safety issue: No ]. 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. [ Time Frame: 1 year ] [Designated as safety issue: No ].
Starting date	December 2008.
Contact information	Michel KINDO, MD. University Hospital, Strasbourg. France. E‐mail: michel.kindo@chru‐strasbourg.fr.
Notes	ClinicalTrials.gov Identifier: NCT00811330. This study is currently recruiting participants. First received: December 17, 2008. Last updated: June 18, 2015. Last verified: June 2015.