Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

Aortic Valve Stenosis Clinical Trial

Official title:

Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00811330
• Other study ID #: 3963
• Status: Recruiting
• Phase: Phase 3
• First received: December 17, 2008
• Last updated: June 18, 2015
• Start date: December 2008
• Est. completion date: January 2018

Study information

• Verified date: June 2015
• Source: University Hospital, Strasbourg, France
• Contact: Michel KINDO, MD
• Phone: 33.3.69.55.08.11
• Email: michel.kindo[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Hypertrophy
• Ventricular Hypertrophy

Intervention

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

Locations

Country	Name	City	State
France	Service de Chirurgie Cardio-VasculaireHôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	? 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	No
Secondary	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	No