Statin Induced Regression of Cardiomyopathy Trial - SirCat

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

Sponsors

Lead sponsor: University of Calgary

Collaborator: Heart and Stroke Foundation of Canada

Source 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.

Overall Status Completed
Start Date April 2007
Completion Date November 2010
Primary Completion Date October 2010
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in left ventricular mass at 12 months from baseline 12 months
Secondary Outcome
Measure 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
Enrollment 22
Condition
Intervention

Intervention type: Drug

Intervention name: Atorvastatin

Description: 80 mg pills daily

Arm group label: 1

Intervention type: Drug

Intervention name: Placebo

Description: 80 mg pills daily

Arm group label: 2

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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Robert S. Sheldon, MD, PhD Principal Investigator University of Calgary
Location
facility
University of Calgary, Faculty of Medicine
Location Countries

Canada

Verification Date

December 2013

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Calgary

Investigator full name: Dr. Bob Sheldon

Investigator title: Professor of Cardiac Sciences, Medicine and Medical Genetics

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: 1

Arm group type: Experimental

Description: Atorvastatin

Arm group label: 2

Arm group type: Placebo Comparator

Description: Placebo

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov