Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00811330
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : December 19, 2008
Last Update Posted : June 19, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Ventricular Hypertrophy Drug: Atorvastatin 80 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.
Study Start Date : December 2008
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: 1: Atorvastatin 80 mg.
Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
Drug: Atorvastatin 80 mg
Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.

No Intervention: 2: No Atrovastatine

Primary Outcome Measures :
  1. ♦ 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   70 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00811330

Contact: Michel KINDO, MD

Service de Chirurgie Cardio-VasculaireHôpital Civil Recruiting
Strasbourg, France, 67 091
Contact: Michel KINDO, MD   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Michel KINDO, MD Hôpitaux Universitaires de Strasbourg

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT00811330     History of Changes
Other Study ID Numbers: 3963
First Posted: December 19, 2008    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by University Hospital, Strasbourg, France:
Left ventricular hypertrophy
Aortic valve stenosis
Aortic valve replacement
Cardiopulmonary bypass
Myocardial preconditioning
Left ventricular reverse remodeling

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors