Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2008 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00811330
First received: December 17, 2008
Last updated: August 7, 2014
Last verified: December 2008

December 17, 2008
August 7, 2014
December 2008
January 2018   (final data collection date for primary outcome measure)
♦ 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 ]
Same as current
Complete list of historical versions of study NCT00811330 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis
Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Aortic Valve Stenosis
  • Ventricular Hypertrophy
Drug: Atorvastatin 80 mg
Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
  • Experimental: 1: Atorvastatin 80 mg.
    Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
    Intervention: Drug: Atorvastatin 80 mg
  • No Intervention: 2: No Atrovastatine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2018
January 2018   (final data collection date for primary outcome measure)

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
Both
70 Years to 80 Years
No
Contact: Michel KINDO, MD 33.3.69.55.08.11 michel.kindo@chru-strasbourg.fr
France
 
NCT00811330
3963
No
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Michel KINDO, MD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP