ISRCTN ISRCTN79875836
DOI https://doi.org/10.1186/ISRCTN79875836
ClinicalTrials.gov number NCT00317967
Secondary identifying numbers 001
Submission date
17/05/2007
Registration date
21/08/2007
Last edited
14/02/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Robert S. Sheldon
Scientific

Faculty of Medicine
University of Calgary
3330 Hospital Drive NW
Calgary
T2N 4N1
Canada

Phone +1 403 220 8191
Email sheldon@ucalgary.ca

Study information

Study designProof of concept, prospective, parallel design, placebo-controlled, multi-center, randomized clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleStatin Induced Regression of Cardiomyopathy Trial
Study acronymSir Cat
Study objectivesTreatment 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(s)Conjoint Health Research Ethics Board, 24/08/2006, ref: 20044
Health condition(s) or problem(s) studiedHypertrophic cardiomyopathy.
InterventionOral administration of atorvastatin vs placebo 80 mg once daily for 12 months.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Atorvastatin
Primary outcome measureChange 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 measures1. 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 study start date01/05/2007
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants38
Key inclusion criteria1. 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 childbearing potential
Key exclusion criteria1. 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)
Date of first enrolment01/05/2007
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Canada

Study participating centre

University of Calgary
Calgary
T2N 4N1
Canada

Sponsor information

University of Calgary (Canada)
University/education

University of Calgary
3330 Hospital Drive NW
Calgary
T2N 4N1
Canada

ROR logo "ROR" https://ror.org/03yjb2x39

Funders

Funder type

Charity

Heart and Stroke Foundation of Alberta, NWT and Nunavut (Canada)

No information available

Pfizer Cardiovascular Research Award (Canada)

No information available

Pfizer Canada Inc. donation in kind of study drug (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2016 14/02/2019 Yes No

Editorial Notes

14/02/2019: Publication reference added.