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

Statin Induced Regression of Cardiomyopathy Trial - SirCat

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Cardiomyopathy
• Intervention / Treatment: Drug: Atorvastatin; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • University of Calgary, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; 80 mg pills daily
Experimental: 1; Atorvastatin	Drug: Atorvastatin; 80 mg pills daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in left ventricular mass at 12 months from baseline	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Heart and Stroke Foundation of Canada
• Investigators: Principal Investigator: Robert S. Sheldon, MD, PhD, University of Calgary

Publications and helpful links

General Publications

• Hersi A, Giannoccaro JP, Howarth A, Exner D, Weeks S, Eitel I, Herman RC, Duff H, Ritchie D, Mcrae M, Sheldon R. Statin Induced Regression of Cardiomyopathy Trial: A Randomized, Placebo-controlled Double-blind Trial. Heart Views. 2016 Oct-Dec;17(4):129-135. doi: 10.4103/1995-705X.201784.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: April 24, 2006
• First Submitted That Met QC Criteria: April 24, 2006
• First Posted (Estimate): April 25, 2006

Study Record Updates

• Last Update Posted (Estimate): December 9, 2013
• Last Update Submitted That Met QC Criteria: December 5, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Heart failure; Sudden cardiac death; Arrhythmias; Hypertrophic cardiomyopathy; Statin therapy; Regression
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 1-Sheldon