Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-26 @ 1:50 PM
Study NCT ID:
NCT00317967
Status:
COMPLETED
Last Update Posted:
2013-12-09
First Post:
2006-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the Heart
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2006-04-24', 'studyFirstSubmitQcDate': '2006-04-24', 'lastUpdatePostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in left ventricular mass at 12 months from baseline', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'a decrease in maximal ventricular wall cross sectional width', 'timeFrame': '12 months'}, {'measure': 'a decrease in the incidence of nonsustained ventricular tachycardia', 'timeFrame': '12 months'}, {'measure': 'a decrease in T-wave alternans', 'timeFrame': '12 months'}, {'measure': 'a decrease in the volume of dense myocardial fibrosis', 'timeFrame': '12 months'}, {'measure': 'parameters of diastolic function', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypertrophic cardiomyopathy', 'Statin therapy', 'Regression', 'Heart failure', 'Arrhythmias', 'Sudden cardiac death'], 'conditions': ['Hypertrophic Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '28400935', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and over with HCM in the absence of another cardiac or systemic disease capable of producing a prespecified wall thickening\n\nExclusion Criteria:\n\n* Required use of statin therapy or intolerance\n* A clinical diagnosis of hypertension\n* Indication for statin therapy for primary or secondary prevention of coronary artery disease\n* Current or anticipated indication in ≤ 1 year for implantable cardioverter defibrillators or other metallic devices preventing cardiac magnetic resonance imaging (MRI).'}, 'identificationModule': {'nctId': 'NCT00317967', 'briefTitle': 'Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the Heart', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Statin Induced Regression of Cardiomyopathy Trial - SirCat', 'orgStudyIdInfo': {'id': '1-Sheldon'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Atorvastatin', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'description': '80 mg pills daily', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '80 mg pills daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary, Faculty of Medicine', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Robert S. Sheldon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiac Sciences, Medicine and Medical Genetics', 'investigatorFullName': 'Dr. Bob Sheldon', 'investigatorAffiliation': 'University of Calgary'}}}}