Skip to content

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00317967
Enrollment
22
Registered
2006-04-25
Start date
2007-04-30
Completion date
2010-11-30
Last updated
2013-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

Keywords

Hypertrophic cardiomyopathy, Statin therapy, Regression, Heart failure, Arrhythmias, Sudden cardiac death

Brief summary

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.

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.

Interventions

DRUGAtorvastatin

80 mg pills daily

DRUGPlacebo

80 mg pills daily

Sponsors

Heart and Stroke Foundation of Canada
CollaboratorOTHER
University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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).

Design outcomes

Primary

MeasureTime frame
Change in left ventricular mass at 12 months from baseline12 months

Secondary

MeasureTime frame
a decrease in T-wave alternans12 months
a decrease in the volume of dense myocardial fibrosis12 months
parameters of diastolic function12 months
a decrease in the incidence of nonsustained ventricular tachycardia12 months
a decrease in maximal ventricular wall cross sectional width12 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026