Condition category
Circulatory System
Date applied
17/05/2007
Date assigned
21/08/2007
Last edited
21/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University of Calgary (Canada)

Sponsor details

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

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes