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

Sponsors and Collaborators:	University of Calgary Heart and Stroke Foundation of Alberta, NWT & Nunavut
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00317967

Purpose

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 III

Genetics Home Reference related topics: short QT syndrome

MedlinePlus related topics: Cardiomyopathy Statins

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Statin Induced Regression of Cardiomyopathy Trial - SirCat

Further study details as provided by University of Calgary:

Primary Outcome Measures:

Change in left ventricular mass at 12 months from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

a decrease in maximal ventricular wall cross sectional width [ Time Frame: 12 months ] [ Designated as safety issue: No ]
a decrease in the incidence of nonsustained ventricular tachycardia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
a decrease in T-wave alternans [ Time Frame: 12 months ] [ Designated as safety issue: No ]
a decrease in the volume of dense myocardial fibrosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
parameters of diastolic function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Atorvastatin	Drug: Atorvastatin 80 mg pills daily
2: Placebo Comparator Placebo	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317967

Contacts

Contact: Robert S. Sheldon, MD, PhD

403-220-8191

sheldon@ucalgary.ca

Locations

Canada, Alberta
University of Calgary, Faculty of Medicine	Recruiting
Calgary, Alberta, Canada, T2N 4N1
Principal Investigator: Robert S. Sheldon, MD, PhD

Sponsors and Collaborators

University of Calgary

Heart and Stroke Foundation of Alberta, NWT & Nunavut

Investigators

Principal Investigator:

Robert S. Sheldon, MD, PhD

University of Calgary

More Information

Responsible Party:	University of Calgary ( Dr. Robert S. Sheldon )
Study ID Numbers:	1-Sheldon
Study First Received:	April 24, 2006
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00317967
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

Hypertrophic cardiomyopathy
Statin therapy
Regression

Heart failure
Arrhythmias
Sudden cardiac death

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Heart Failure
Death
Heart Diseases
Constriction, Pathologic
Aortic valve stenosis
Cardiomyopathies

Heart Valve Diseases
Hypertrophy
Cardiomyopathy, Hypertrophic
Death, Sudden, Cardiac
Aortic Valve Stenosis
Atorvastatin
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Antimetabolites
Aortic Stenosis, Subvalvular
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009