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ISRCTN
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ISRCTN79875836
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ClinicalTrials.gov identifier
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NCT00317967
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Public title
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Statin Induced Regression of Cardiomyopathy Trial
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Scientific title
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Acronym
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Sir Cat
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Serial number at source
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001
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Study hypothesis
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Treatment with atorvastatin will reduce left ventricular mass and left ventricular focal fibrosis volume, leading to decreased left ventricular wall thickness, decreased left ventricular outflow tract obstruction, improvement in symptoms, decreased propensity to ventricular arrhythmia, and improvement in myocardial relaxation.
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Lay summary
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Ethics approval
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Conjoint Health Research Ethics Board, approved on 24 August 2006. Ref: 20044.
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Study design
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Proof of concept, prospective, parallel design, placebo-controlled, multi-center, randomized clinical trial.
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Hypertrophic cardiomyopathy.
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Participants - inclusion criteria
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1. 18 years of age and over
2. Hypertrophic cardiomyopathy based on the 2-dimensional echocardiography identification of hypertrophied, nondilated left ventricle (wall thickness with septal-to-posterior wall thickness ratio of 1.3:1) in the absence of another cardiac or systematic disease capable of producing this magnitude of wall thickening
3. Patients may be enrolled > 6 months following either a myectomy or a septal ablation procedure
4. Negative pregnancy test at baseline if female of child bearing potential
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Participants - exclusion criteria
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1. Use of statin therapy or have statin intolerance
2. Clinical diagnosis of hypertension i.e. untreated blood pressure >140/90 on two occasions when measured supine after five minutes at rest
3. Less than six months following either a myectomy or a septal ablation procedure
5. Indication for statin therapy for primary or secondary prevention of coronary artery disease
6. Current or anticipated indication in =< 1 year for implantable cardioverter defibrillators or other metallic devices preventing cardiac Magnetic Resonance Imaging (MRI)
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Anticipated start date
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01/05/2007
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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38
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Interventions
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Oral administration of atorvastatin vs placebo 80 mg once daily for 12 months.
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Primary outcome measure(s)
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Change in left ventricular mass at 12 months from baseline, assessed by 3-dimensional cardiac magnetic resonance imaging at baseline, 6 and 12 months.
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Secondary outcome measure(s)
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1. Decrease in the incidence of NonSustained Ventricular Tachycardia (NSVT defined as greater than or equal to three consecutive ventricular extrasystoles at greater than or equal to 120 beats per minute), assessed by Holter monitor at baseline, 6 and 12 months
2. Decrease in T wave alternans, assessed by T wave alternans testing at baseline and 12 months
3. Decrease in maximal ventricular wall cross-sectional width
4. Decrease in the volume of dense myocardial fibrosis (absolute fibrotic mass and percentage) as quantified through cardiac magnetic resonance imaging at baseline, 6 and 12 months
5. Laboratory work: creatinine kinase, Creatine Kinase - Myocardial Bands (CKMB), ASpartate aminoTransferase (AST) and ALanine aminoTransferase (ALT) at baseline, 6 and 12 months
6. Quality of Life questionnaire at baseline, 6 and 12 months
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Sources of funding
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1. Heart and Stroke Foundation of Alberta, NWT and Nunavut (Canada)
2. Pfizer Cardiovascular Research Award (Canada)
3. Pfizer Canada Inc. donation in kind of study drug (Canada)
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Trial website
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Publications
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Contact name
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Dr
Robert S.
Sheldon
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Address
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Faculty of Medicine
University of Calgary
3330 Hospital Drive NW
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City/town
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Calgary
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Zip/Postcode
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T2N 4N1
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Country
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Canada
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Tel
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+1 403 220 8191
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Fax
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+1 403 270 0313
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Email
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sheldon@ucalgary.ca
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Sponsor
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University of Calgary (Canada)
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Address
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University of Calgary
3330 Hospital Drive NW
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City/town
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Calgary
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Zip/Postcode
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T2N 4N1
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Country
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Canada
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Date applied
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17/05/2007
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Last edited
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21/08/2007
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Date ISRCTN assigned
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21/08/2007
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