Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the Heart
Tracking Information | |||||
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First Received Date ICMJE | April 24, 2006 | ||||
Last Updated Date | April 24, 2012 | ||||
Start Date ICMJE | April 2007 | ||||
Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in left ventricular mass at 12 months from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Change in left ventricular mass at 12 months from baseline. | ||||
Change History | Complete list of historical versions of study NCT00317967 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
A decrease in the incidence of nonsustained ventricular tachycardia, in T-wave alternans; in maximal ventricular wall cross-sectional width; in volume of dense myocardial fibrosis, and parameters of diastolic function at 12 months from baseline. | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the Heart | ||||
Official Title ICMJE | Statin Induced Regression of Cardiomyopathy Trial - SirCat | ||||
Brief Summary | The purpose of this study is to determine if a drug called atorvastatin will reduce the size and stiffness of the muscle in the left ventricle of the heart. |
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Detailed Description | Hypertrophic cardiomyopathy (HCM) is a primary disorder of the heart characterized by a thickened, fibrotic myocardium, with or without a dynamic left ventricular outflow tract gradient. It is a common heritable cardiovascular disease, with a population prevalence of 0.1% to 0.2%. Symptoms of congestive heart failure are extremely common in patients with HCM. Progression to disabling and debilitating symptoms [New York Heart Association (NYHA) class III and IV] is relatively common, occurring in 15% to 20% of unselected populations. The rate of progression to NYHA class III or IV or death from heart failure or stroke is high, with a relative risk 2.7. Management of symptoms can be very challenging, involve multiple medications, and 5% of patients may develop drug refractory heart failure, requiring invasive intervention. HCM is the most common cause of sudden death among young competitive athletes. Ventricular tachyarrhythmias appear to be the primary mechanism; however, other arrhythmias involved include asystole, rapid atrial fibrillation, and electrical mechanical dissociation. Patients may develop progressive myocardial wall thinning, a reduction in systolic performance, and an increase in left ventricular dimensions. Progressive wall thinning may be especially common in patients with initially severe hypertrophy. There is no cure for this condition. There is now evidence from both animal and human studies of a treatment that promises to reverse hypertrophy - HMG CoA reductase inhibitors. Clearly, studies of treatments that might cause regression of hypertrophy are timely and important. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Hypertrophic Cardiomyopathy | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 22 | ||||
Completion Date | November 2010 | ||||
Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00317967 | ||||
Other Study ID Numbers ICMJE | 1-Sheldon | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Dr. Bob Sheldon, University of Calgary | ||||
Study Sponsor ICMJE | University of Calgary | ||||
Collaborators ICMJE | Heart and Stroke Foundation of Canada | ||||
Investigators ICMJE |
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Information Provided By | University of Calgary | ||||
Verification Date | April 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |