Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

Phase 3

• Conditions: Ventricular Hypertrophy; Aortic Valve Stenosis
• Interventions: Drug: Atorvastatin 80 mg

• Registration Number: NCT00811330
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-18
• Study First Posted: 2008-12-19
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-18
• Last Update Posted: 2015-06-19
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
♦ 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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service de Chirurgie Cardio-VasculaireHôpital Civil; 🇫🇷 Strasbourg, France