Contact information
Type
Scientific
Primary contact
Dr Robert S. Sheldon
ORCID ID
Contact details
Faculty of Medicine
University of Calgary
3330 Hospital Drive NW
Calgary
T2N 4N1
Canada
+1 403 220 8191
sheldon@ucalgary.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00317967
Protocol/serial number
001
Study information
Scientific title
Acronym
Sir Cat
Study hypothesis
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.
Ethics approval
Conjoint Health Research Ethics Board, approved on 24 August 2006. Ref: 20044.
Study design
Proof of concept, prospective, parallel design, placebo-controlled, multi-center, randomized clinical trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Hypertrophic cardiomyopathy.
Intervention
Oral administration of atorvastatin vs placebo 80 mg once daily for 12 months.
Intervention type
Drug
Phase
Not Specified
Drug names
atorvastatin
Primary outcome measures
Change in left ventricular mass at 12 months from baseline, assessed by 3-dimensional cardiac magnetic resonance imaging at baseline, 6 and 12 months.
Secondary outcome measures
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
Overall trial start date
01/05/2007
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
38
Participant exclusion criteria
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)
Recruitment start date
01/05/2007
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Canada
Trial participating centre
Faculty of Medicine
Calgary
T2N 4N1
Canada
Funders
Funder type
Not defined
Funder name
Heart and Stroke Foundation of Alberta, NWT and Nunavut (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer Cardiovascular Research Award (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer Canada Inc. donation in kind of study drug (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary