Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317967
Status:
COMPLETED
Last Update Posted:
2013-12-09
First Post:
2006-04-24
Brief Title:
Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the Heart
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Statin Induced Regression of Cardiomyopathy Trial - SirCat
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 01 to 02 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 27 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None