search
Back to results

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

Primary Purpose

Hypertrophic Cardiomyopathy

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Cardiomyopathy focused on measuring Hypertrophic cardiomyopathy, Statin therapy, Regression, Heart failure, Arrhythmias, Sudden cardiac death

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Calgary, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Atorvastatin

Placebo

Outcomes

Primary Outcome Measures

Change in left ventricular mass at 12 months from baseline

Secondary Outcome Measures

a decrease in maximal ventricular wall cross sectional width
a decrease in the incidence of nonsustained ventricular tachycardia
a decrease in T-wave alternans
a decrease in the volume of dense myocardial fibrosis
parameters of diastolic function

Full Information

First Posted
April 24, 2006
Last Updated
December 5, 2013
Sponsor
University of Calgary
Collaborators
Heart and Stroke Foundation of Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT00317967
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Heart and Stroke Foundation of Canada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
Keywords
Hypertrophic cardiomyopathy, Statin therapy, Regression, Heart failure, Arrhythmias, Sudden cardiac death

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Atorvastatin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
80 mg pills daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
80 mg pills daily
Primary Outcome Measure Information:
Title
Change in left ventricular mass at 12 months from baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
a decrease in maximal ventricular wall cross sectional width
Time Frame
12 months
Title
a decrease in the incidence of nonsustained ventricular tachycardia
Time Frame
12 months
Title
a decrease in T-wave alternans
Time Frame
12 months
Title
a decrease in the volume of dense myocardial fibrosis
Time Frame
12 months
Title
parameters of diastolic function
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S. Sheldon, MD, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary, Faculty of Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28400935
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs