Brief Title
Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis
Official Title
Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.
Brief Summary
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
♦ 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).
Secondary Outcome
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.
Condition
Aortic Valve Stenosis
Intervention
Atorvastatin 80 mg
Study Arms / Comparison Groups
1: Atorvastatin 80 mg.
Description: Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
December 2008
Completion Date
January 2018
Primary Completion Date
January 2018
Eligibility Criteria
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
Gender
All
Ages
70 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Michel KINDO, MD, 33.3.69.55.08.11, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00811330
Organization ID
3963
Responsible Party
Sponsor
Study Sponsor
University Hospital, Strasbourg, France
Study Sponsor
Michel KINDO, MD, Principal Investigator, Hôpitaux Universitaires de Strasbourg
Verification Date
June 2015