Statin Induced Regression of Cardiomyopathy Trial

Not Applicable

Completed

• Conditions: Hypertrophic cardiomyopathy.; Circulatory System; Hypertrophic cardiomyopathy

• Registration Number: ISRCTN79875836
• Lead Sponsor: niversity of Calgary (Canada)

Brief Summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/28400935 [added 14/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-21
• Study Completion: 2010-12-31
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 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<br> 2. Decrease in T wave alternans, assessed by T wave alternans testing at baseline and 12 months<br> 3. Decrease in maximal ventricular wall cross-sectional width<br> 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<br> 5. Laboratory work: creatinine kinase, Creatine Kinase - Myocardial Bands (CKMB), ASpartate aminoTransferase (AST) and ALanine aminoTransferase (ALT) at baseline, 6 and 12 months<br> 6. Quality of Life questionnaire at baseline, 6 and 12 months<br>