Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT06338202
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2024-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-World Effectiveness of Mavacamten in Canada
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000605992', 'term': 'MYK-461'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation', 'timeFrame': 'Up to 1.5 years', 'description': '* Proportion of patients in each New York Heart Association (NYHA) functional class following mavacamten treatment initiation\n* Proportion of patients with a reduction of ≥1 New York Heart Association (NYHA) functional class following mavacamten treatment initiation'}], 'secondaryOutcomes': [{'measure': 'Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Age', 'timeFrame': 'Baseline'}, {'measure': 'Sex at birth', 'timeFrame': 'Baseline'}, {'measure': 'Ethnicity', 'timeFrame': 'Baseline'}, {'measure': 'Employment status', 'timeFrame': 'Baseline'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Baseline'}, {'measure': 'Obstructive hypertrophic cardiomyopathy (oHCM) disease duration', 'timeFrame': 'Baseline'}, {'measure': 'Proportion of patients in each New York Heart Association (NYHA) functional class II and III', 'timeFrame': 'Baseline'}, {'measure': 'Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient', 'timeFrame': 'Baseline'}, {'measure': 'Left ventricular ejection fraction by 2D echocardiogram (LVEFb)', 'timeFrame': 'Baseline'}, {'measure': 'Mavacamten dose regimen', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Proportion of patients who discontinued mavacamten', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Duration of treatment prior to mavacamten discontinuation', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Reason for discontinuing mavacamten treatment', 'timeFrame': 'Up to 1.5 years'}, {'measure': 'Functional assessment schedule', 'timeFrame': 'Up to 1.5 years', 'description': '* Proportion of patients who undergo left ventricular outflow tract with Valsalva maneuver gradient (vLVOT) functional assessment\n* Proportion of patients who undergo left ventricular ejection fraction (LVEF) assessment'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Hypertrophic Cardiomyopathy (oHCM)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The observational study will include adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) who are enrolled in the Bristol Myers Squibb (BMS)-sponsored CAMZYOS Patient Support Program and who have initiated mavacamten as part of routine clinical care in Canada.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have initiated mavacamten, as part of routine clinical care, through the Bristol Myers Squibb CAMZYOS Patient Support Program for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM)\n* Adult patient (≥18 years of age or as defined per local province/territory) at Index Date (first prescribed dose of mavacamten).\n* Patient has been diagnosed with symptomatic oHCM of New York Heart Association (NYHA) class II to III at the time of mavacamten initiation.\n\nExclusion Criteria:\n\n* In the 6 weeks prior to baseline (i.e., Index Date; date of first prescribed dose of mavacamten), patient has received any cardiac myosin inhibitor (including mavacamten) for oHCM or any other medical condition as part of a clinical trial.'}, 'identificationModule': {'nctId': 'NCT06338202', 'acronym': 'MAVEN', 'briefTitle': 'Real-World Effectiveness of Mavacamten in Canada', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Real-World Effectiveness of MAVacamtEN in Canada (MAVEN): A Retrospective Physician Survey of Patient Charts', 'orgStudyIdInfo': {'id': 'CV027-1137'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with mavacamten', 'description': 'Patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA functional class II-III) who receive mavacamten as part of routine clinical care', 'interventionNames': ['Drug: Mavacamten']}], 'interventions': [{'name': 'Mavacamten', 'type': 'DRUG', 'description': 'As detailed in the product label', 'armGroupLabels': ['Patients treated with mavacamten']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Science Centre (LHSC)', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}