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

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Dr. Bob Sheldon, University of Calgary
ClinicalTrials.gov Identifier:
NCT00317967
First received: April 24, 2006
Last updated: December 5, 2013
Last verified: December 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ]

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
Atorvastatin
Drug: Atorvastatin
80 mg pills daily
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Principal Investigator: Robert S. Sheldon, MD, PhD University of Calgary
  More Information

No publications provided

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

Keywords provided by University of Calgary:
Hypertrophic cardiomyopathy
Statin therapy
Regression
Heart failure
Arrhythmias
Sudden cardiac death

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014