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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.
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

April 24, 2006
December 5, 2013
April 2007
October 2010   (final data collection date for primary outcome measure)
Change in left ventricular mass at 12 months from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in left ventricular mass at 12 months from baseline.
Complete list of historical versions of study NCT00317967 on ClinicalTrials.gov Archive Site
  • 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 ]
A decrease in the incidence of nonsustained ventricular tachycardia, in T-wave alternans; in maximal ventricular wall cross-sectional width; in volume of dense myocardial fibrosis, and parameters of diastolic function at 12 months from baseline.
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertrophic Cardiomyopathy
  • Drug: Atorvastatin
    80 mg pills daily
  • Drug: Placebo
    80 mg pills daily
  • Experimental: 1
    Atorvastatin
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2010
October 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00317967
1-Sheldon
Yes
Dr. Bob Sheldon, University of Calgary
University of Calgary
Heart and Stroke Foundation of Canada
Principal Investigator: Robert S. Sheldon, MD, PhD University of Calgary
University of Calgary
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP