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Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

This study is currently recruiting participants.
Verified June 2015 by University Hospital, Strasbourg, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT00811330
First Posted: December 19, 2008
Last Update Posted: June 19, 2015
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  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 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • ♦ 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:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: December 2008
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00811330


Contacts
Contact: Michel KINDO, MD 33.3.69.55.08.11 michel.kindo@chru-strasbourg.fr

Locations
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   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Michel KINDO, MD Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00811330     History of Changes
Other Study ID Numbers: 3963
First Submitted: December 17, 2008
First Posted: December 19, 2008
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
Statins
Myocardial preconditioning
Left ventricular reverse remodeling

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