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| Sponsored by: |
University Hospital, Strasbourg, France |
|---|---|
| Information provided by: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT00811330 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Aortic Valve Stenosis Ventricular Hypertrophy |
Drug: Atorvastatin 80 mg |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling. |
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Atorvastatin 80 mg.: Experimental
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.
|
| 2: No Atrovastatine: No Intervention |
Eligibility| Ages Eligible for Study: | 70 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michel KINDO, MD | 33.3.69.55.08.11 | michel.kindo@chru-strasbourg.fr |
| France | |
| Service de Chirurgie Cardio-VasculaireHôpital Civil | Recruiting |
| STRASBOURG, France, 67 091 | |
| Contact: Michel KINDO, MD 33.3.69.55.08.11 michel.kindo@chru-strasbourg.fr | |
| Contact: Michel KINDO, MD 33.3.69.55.08.11 michel.kindo@chru-strasbourg.fr | |
| Principal Investigator: | Michel KINDO, MD | Hôpitaux Universitaires de Strasbourg |
More Information
| Responsible Party: | University Hospital, Strasbourg, France ( C. GEILLER, Directeur Adjoint chargé de la Recherche Clinique et des Innovations ) |
| Study ID Numbers: | 3963 |
| Study First Received: | December 17, 2008 |
| Last Updated: | December 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00811330 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Left ventricular hypertrophy Aortic valve stenosis Aortic valve replacement Cardiopulmonary bypass |
Statins Myocardial preconditioning Left ventricular reverse remodeling |
|
Antimetabolites Pathological Conditions, Anatomical Hypertrophy, Left Ventricular Hypertrophy Heart Diseases Antilipemic Agents |
Constriction, Pathologic Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Aortic Valve Stenosis Atorvastatin Heart Valve Diseases |
|
Pathological Conditions, Anatomical Antimetabolites Heart Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Constriction, Pathologic Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Pharmacologic Actions Heart Valve Diseases Hypertrophy Therapeutic Uses Cardiovascular Diseases Aortic Valve Stenosis Atorvastatin Ventricular Outflow Obstruction |
