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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00317967 |
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Date of registration:
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24/04/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the Heart
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Scientific title:
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Statin Induced Regression of Cardiomyopathy Trial - SirCat |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00317967 |
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Study type:
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Interventional |
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Study design:
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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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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Robert S. Sheldon, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Calgary |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years and over with HCM in the absence of another cardiac or systemic disease
capable of producing a prespecified wall thickening
Exclusion Criteria:
- Required use of statin therapy or intolerance
- A clinical diagnosis of hypertension
- Indication for statin therapy for primary or secondary prevention of coronary artery
disease
- Current or anticipated indication in = 1 year for implantable cardioverter
defibrillators or other metallic devices preventing cardiac magnetic resonance
imaging (MRI).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertrophic Cardiomyopathy
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Intervention(s)
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Drug: Atorvastatin
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Drug: Placebo
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Primary Outcome(s)
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Change in left ventricular mass at 12 months from baseline
[Time Frame: 12 months]
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Secondary Outcome(s)
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a decrease in the incidence of nonsustained ventricular tachycardia
[Time Frame: 12 months]
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parameters of diastolic function
[Time Frame: 12 months]
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a decrease in maximal ventricular wall cross sectional width
[Time Frame: 12 months]
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a decrease in T-wave alternans
[Time Frame: 12 months]
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a decrease in the volume of dense myocardial fibrosis
[Time Frame: 12 months]
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Secondary ID(s)
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1-Sheldon
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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