Clinical trial NCT00317967: Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the Heart
Official title: Statin Induced Regression of Cardiomyopathy Trial - SirCat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertrophic Cardiomyopathy
Keywords: Hypertrophic cardiomyopathy
Statin therapy
Regression
Heart failure
Arrhythmias
Sudden cardiac death
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2006-04-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Change in left ventricular mass at 12 months from baseline
timeFrame: 12 months
Secondary outcomes:
measure: a decrease in maximal ventricular wall cross sectional width
timeFrame: 12 months
measure: a decrease in the incidence of nonsustained ventricular tachycardia
timeFrame: 12 months
measure: a decrease in T-wave alternans
timeFrame: 12 months
measure: a decrease in the volume of dense myocardial fibrosis
timeFrame: 12 months
measure: parameters of diastolic function
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary, Faculty of Medicine
state: Alberta
Study officials:
affiliation: University of Calgary
name: Robert S. Sheldon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.