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

Phase 3

Completed

• Conditions: Hypertrophic Cardiomyopathy
• Interventions: Drug: Placebo; Drug: Atorvastatin

• Registration Number: NCT00317967
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study First Submitted: 2006-04-24
• Study First Submitted QC: 2006-04-24
• Study First Posted: 2006-04-25
• Study Start: 2007-04
• Primary Completion: 2010-10
• Study Completion: 2010-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Atorvastatin	Atorvastatin

Primary Outcome Measures

Name	Time	Method
Change in left ventricular mass at 12 months from baseline	12 months

Secondary Outcome Measures

Name	Time	Method
a decrease in the volume of dense myocardial fibrosis	12 months
parameters of diastolic function	12 months
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

Trial Locations

Locations (1)

University of Calgary, Faculty of Medicine; 🇨🇦 Calgary, Alberta, Canada