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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Statin Induced Regression of Cardiomyopathy Trial - SirCat

Conditions
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Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Atorvastatin | Drug: Atorvastatin<br>* 80 mg pills daily<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* 80 mg pills daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricular mass at 12 months from baseline |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a decrease in maximal ventricular wall cross sectional width |  | 12 months | 
| a decrease in the incidence of nonsustained ventricular tachycardia |  | 12 months | 
| a decrease in T-wave alternans |  | 12 months | 
| a decrease in the volume of dense myocardial fibrosis |  | 12 months | 
| parameters of diastolic function |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertrophic cardiomyopathy, Statin therapy, Regression, Heart failure, Arrhythmias, Sudden cardiac death