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Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the Heart

This study has been completed.
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Dr. Bob Sheldon, University of Calgary Identifier:
First received: April 24, 2006
Last updated: December 5, 2013
Last verified: December 2013
The purpose of this study is to determine if a drug called atorvastatin will reduce the size and stiffness of the muscle in the left ventricle of the heart.

Condition Intervention Phase
Hypertrophic Cardiomyopathy Drug: Atorvastatin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Statin Induced Regression of Cardiomyopathy Trial - SirCat

Resource links provided by NLM:

Further study details as provided by Dr. Bob Sheldon, University of Calgary:

Primary Outcome Measures:
  • Change in left ventricular mass at 12 months from baseline [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • a decrease in maximal ventricular wall cross sectional width [ Time Frame: 12 months ]
  • a decrease in the incidence of nonsustained ventricular tachycardia [ Time Frame: 12 months ]
  • a decrease in T-wave alternans [ Time Frame: 12 months ]
  • a decrease in the volume of dense myocardial fibrosis [ Time Frame: 12 months ]
  • parameters of diastolic function [ Time Frame: 12 months ]

Enrollment: 22
Study Start Date: April 2007
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Atorvastatin
80 mg pills daily
Placebo Comparator: 2
Drug: Placebo
80 mg pills daily

Detailed Description:
Hypertrophic cardiomyopathy (HCM) is a primary disorder of the heart characterized by a thickened, fibrotic myocardium, with or without a dynamic left ventricular outflow tract gradient. It is a common heritable cardiovascular disease, with a population prevalence of 0.1% to 0.2%. Symptoms of congestive heart failure are extremely common in patients with HCM. Progression to disabling and debilitating symptoms [New York Heart Association (NYHA) class III and IV] is relatively common, occurring in 15% to 20% of unselected populations. The rate of progression to NYHA class III or IV or death from heart failure or stroke is high, with a relative risk 2.7. Management of symptoms can be very challenging, involve multiple medications, and 5% of patients may develop drug refractory heart failure, requiring invasive intervention. HCM is the most common cause of sudden death among young competitive athletes. Ventricular tachyarrhythmias appear to be the primary mechanism; however, other arrhythmias involved include asystole, rapid atrial fibrillation, and electrical mechanical dissociation. Patients may develop progressive myocardial wall thinning, a reduction in systolic performance, and an increase in left ventricular dimensions. Progressive wall thinning may be especially common in patients with initially severe hypertrophy. There is no cure for this condition. There is now evidence from both animal and human studies of a treatment that promises to reverse hypertrophy - HMG CoA reductase inhibitors. Clearly, studies of treatments that might cause regression of hypertrophy are timely and important.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years and over with HCM in the absence of another cardiac or systemic disease capable of producing a prespecified wall thickening

Exclusion Criteria:

  • Required use of statin therapy or intolerance
  • A clinical diagnosis of hypertension
  • Indication for statin therapy for primary or secondary prevention of coronary artery disease
  • Current or anticipated indication in ≤ 1 year for implantable cardioverter defibrillators or other metallic devices preventing cardiac magnetic resonance imaging (MRI).
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Please refer to this study by its identifier: NCT00317967

Canada, Alberta
University of Calgary, Faculty of Medicine
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
Heart and Stroke Foundation of Canada
Principal Investigator: Robert S. Sheldon, MD, PhD University of Calgary
  More Information

Responsible Party: Dr. Bob Sheldon, Professor of Cardiac Sciences, Medicine and Medical Genetics, University of Calgary Identifier: NCT00317967     History of Changes
Other Study ID Numbers: 1-Sheldon
Study First Received: April 24, 2006
Last Updated: December 5, 2013

Keywords provided by Dr. Bob Sheldon, University of Calgary:
Hypertrophic cardiomyopathy
Statin therapy
Heart failure
Sudden cardiac death

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on September 19, 2017