Statin Induced Regression of Cardiomyopathy Trial
| 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
Scientific
Faculty of Medicine
University of Calgary
3330 Hospital Drive NW
Calgary
T2N 4N1
Canada
| Phone | +1 403 220 8191 |
|---|---|
| sheldon@ucalgary.ca |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Statin Induced Regression of Cardiomyopathy Trial |
| Study acronym | Sir Cat |
| Study objectives | 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(s) | Conjoint Health Research Ethics Board, 24/08/2006, ref: 20044 |
| Health condition(s) or problem(s) studied | Hypertrophic cardiomyopathy. |
| Intervention | Oral administration of atorvastatin vs placebo 80 mg once daily for 12 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Atorvastatin |
| Primary outcome measure | 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 study start date | 01/05/2007 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 38 |
| Key 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 childbearing potential |
| Key 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) |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
University of Calgary
Calgary
T2N 4N1
Canada
T2N 4N1
Canada
Sponsor information
University of Calgary (Canada)
University/education
University/education
University of Calgary
3330 Hospital Drive NW
Calgary
T2N 4N1
Canada
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
