- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00811330
Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis
June 18, 2015 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michel KINDO, MD
- Phone Number: 33.3.69.55.08.11
- Email: michel.kindo@chru-strasbourg.fr
Study Locations
-
-
-
Strasbourg, France, 67 091
- Recruiting
- Service de Chirurgie Cardio-VasculaireHôpital Civil
-
Contact:
- Michel KINDO, MD
- Phone Number: 33.3.69.55.08.11
- Email: michel.kindo@chru-strasbourg.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years to 80 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
Atorvastatin 80 mg PO every day for one year.
The treatment will start 4 weeks before aortic valve replacement.
|
No Intervention: 2: No Atrovastatine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
♦ 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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michel KINDO, MD, Hôpitaux Universitaires de Strasbourg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Anticipated)
January 1, 2018
Study Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
December 17, 2008
First Submitted That Met QC Criteria
December 18, 2008
First Posted (Estimate)
December 19, 2008
Study Record Updates
Last Update Posted (Estimate)
June 19, 2015
Last Update Submitted That Met QC Criteria
June 18, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Pathological Conditions, Anatomical
- Aortic Valve Disease
- Heart Valve Diseases
- Ventricular Outflow Obstruction
- Aortic Valve Stenosis
- Hypertrophy
- Constriction, Pathologic
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- 3963
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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