Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-26 @ 2:25 PM
Study NCT ID:
NCT06372457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
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': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis', 'timeFrame': 'Baseline, index date'}, {'measure': 'Participant age at mavacamten treatment initiation', 'timeFrame': 'Index date'}, {'measure': 'Participant sex', 'timeFrame': 'Baseline'}, {'measure': 'Participant race/ethnicity', 'timeFrame': 'Baseline'}, {'measure': 'Participant insurance coverage', 'timeFrame': 'Baseline'}, {'measure': 'Participant employment status', 'timeFrame': 'Baseline'}, {'measure': 'Participant educational level', 'timeFrame': 'Baseline'}, {'measure': 'Date of Hypertrophic Cardiomyopathy (HCM) diagnosis', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis', 'timeFrame': 'Baseline or index date'}, {'measure': 'Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis', 'timeFrame': 'Baseline or index date, and up to 33 months'}, {'measure': 'Participant New York Heart Association (NYHA) class', 'timeFrame': 'Baseline or index date, and up to 33 months'}, {'measure': 'Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis', 'timeFrame': 'Baseline'}, {'measure': 'Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis', 'timeFrame': 'Baseline'}, {'measure': 'Participant height', 'timeFrame': 'Baseline'}, {'measure': 'Participant weight', 'timeFrame': 'Baseline'}, {'measure': 'Participant blood pressure', 'timeFrame': 'Baseline'}, {'measure': 'Participant heart rate', 'timeFrame': 'Baseline'}, {'measure': 'Participant Hypertrophic Cardiomyopathy (HCM) symptoms', 'timeFrame': 'Baseline or index date, and up to 33 months'}, {'measure': 'European participant CYP2C19 genotype', 'timeFrame': 'Baseline or index date, and up to 33 months'}, {'measure': 'Participant family history of Hypertrophic Cardiomyopathy (HCM)', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM)', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant family history of sudden cardiac death (SCD)', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant smoking status', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant alcohol use', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant recreational drug use', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT)', 'timeFrame': 'Baseline or index date, and up to 33 months'}, {'measure': 'Participant cardiovascular (CV) and CV-related comorbidities', 'timeFrame': 'Baseline and index date', 'description': "Comorbidities include:\n\n* Aortic stenosis\n* Cardiomyopathies, other (dilated, restrictive, arrhythmogenic right ventricular dysplasia, takotsubo cardiomyopathy)\n* Chronic kidney disease\n* Coronary heart disease\n* Deep venous thrombosis (DVT)\n* Heart failure\n* Hyperlipidemia\n* Hypertension\n* Hypertensive renal disease\n* Mitral valve prolapse\n* Peripheral vascular disease\n* Pulmonary hypertension\n* Phenocopy disorders (athlete's heart, hypertensive heart disease, Fabry disease, Pompe disease, Danon disease, amyloidosis)"}, {'measure': 'Participant non-cardiovascular (CV)-related comorbidities', 'timeFrame': 'Baseline or index date', 'description': 'Including:\n\n* Anxiety/panic attacks\n* Asthma\n* COPD\n* Depression\n* Diabetes\n* Liver diseases'}, {'measure': 'Participant electrocardiogram (ECG) rhythm results', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant cardiac magnetic resonance imaging (MRI) results', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant cardiac troponin results', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant cardiopulmonary exercise test (CPET) results', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant cardiac monitoring results', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant exercise test results', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant blood creatine levels', 'timeFrame': 'Baseline or index date'}, {'measure': 'Participant cardiovascular (CV) events', 'timeFrame': 'Baseline', 'description': 'Cardiovascular events include:\n\n* Atrial fibrillation\n* Atrial flutter\n* Myocardial infarction (MI)\n* Stroke\n* Transient ischemic attack (TIA)\n* Cardiac arrest\n* Sudden cardiac death (SCD)\n* Arrhythmia\n* Heart failure exacerbation\n* Incident heart failure\n* Ventricular fibrillation\n* Syncope'}, {'measure': 'Type of procedures received by participants', 'timeFrame': 'Baseline or index date, and up to 33 months', 'description': 'Procedures include:\n\n* Septal reduction therapy (SRT)\n* Implantable cardioverter defibrillator (ICD), including CRT-D\n* Pacemaker\n* Cardiac resynchronization therapy (CRT)\n* Atrial fibrillation ablation\n* Cardioversion\n* Heart transplant/use of ventricular assist device\n* Heart failure monitoring (e.g., CardioMEMS)\n* Percutaneous cutaneous intervention (PCI)'}, {'measure': 'Cardiovascular treatments prescribed to participants', 'timeFrame': 'Baseline, and up to 33 months'}, {'measure': 'Date of mavacamten prescription', 'timeFrame': 'Baseline'}, {'measure': 'Date of mavacamten treatment initiation', 'timeFrame': 'Index date'}, {'measure': 'Date of mavacamten dosage change', 'timeFrame': 'Up to 33 months'}, {'measure': 'Reason for mavacamten dosage change', 'timeFrame': 'Up to 33 months'}, {'measure': 'Occurrence of mavacamten stable dose (a period of 6-months with the same dose)', 'timeFrame': 'Up to 33 months'}, {'measure': 'Dates of follow-up after mavacamten treatment initiation', 'timeFrame': 'Up to 33 months'}, {'measure': 'Date of mavacamten treatment interuption or discontinuation', 'timeFrame': 'Up to 33 months'}, {'measure': 'Reason for mavacamten treatment interuption or discontinuation', 'timeFrame': 'Up to 33 months'}, {'measure': 'Supportive care provided to participants', 'timeFrame': 'Up to 33 months'}, {'measure': 'Heath care resource utilization (HCRU)', 'timeFrame': 'Up to 33 months'}, {'measure': 'Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation', 'timeFrame': 'Up to 33 months'}], 'secondaryOutcomes': [{'measure': 'Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms', 'timeFrame': 'Baseline and index date'}, {'measure': 'Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM)', 'timeFrame': 'Baseline, index date, and up to 33 months'}, {'measure': 'Participant family history of sudden cardiac death (SCD)', 'timeFrame': 'Baseline, index date, and up to 33 months'}, {'measure': 'Cardiovascular (CV) and CV-related comorbidities', 'timeFrame': 'Baseline', 'description': "Including:\n\n* Aortic stenosis\n* Cardiomyopathies\n* Chronic kidney disease\n* Coronary heart disease\n* Heart failure\n* Hyperlipidemia\n* Hypertension (primary)\n* Hypertensive renal disease\n* Mitral valve prolapse\n* Peripheral vascular disease\n* Pulmonary hypertension\n* Phenocopy disorders (athlete's heart, hypertensive heart disease, Fabry disease, Pompe disease, Danon disease, amyloidosis)"}, {'measure': 'Non-cardiovascular (non-CV) comorbidities', 'timeFrame': 'Baseline', 'description': 'Including:\n\n* Anxiety/panic attacks\n* Asthma\n* COPD\n* Depression\n* Diabetes\n* Liver disease'}, {'measure': 'Participant electrocardiogram (ECG) rhythm results', 'timeFrame': 'Baseline'}, {'measure': 'Participant echocardiogram (ECHO) results', 'timeFrame': 'Baseline and index date'}, {'measure': 'Participant cardiac MRI results', 'timeFrame': 'Baseline'}, {'measure': 'Participant NT-proBNP results', 'timeFrame': 'Baseline'}, {'measure': 'Participant cardiac tropin results', 'timeFrame': 'Baseline'}, {'measure': 'Participant cardiopulmonary exercise test (CPET) results', 'timeFrame': 'Baseline'}, {'measure': 'Participant cardiac monitoring results', 'timeFrame': 'Baseline'}, {'measure': 'Participant exercise test results', 'timeFrame': 'Baseline'}, {'measure': 'Hypertrophic Cardiomyopathy (HCM) subtype', 'timeFrame': 'Baseline, index date, and up to 33 months'}, {'measure': 'Participant symptoms at Hypertrophic Cardiomyopathy (HCM)', 'timeFrame': 'Baseline, index date, and up to 33 months'}, {'measure': 'Participant New York Heart Association (NYHA) class', 'timeFrame': 'Baseline, index date, and up to 33 months'}, {'measure': 'Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis', 'timeFrame': 'Baseline'}, {'measure': 'Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mavacamten, oHCM, cardiac myosin inhibitor, NYHA class, echocardiogram parameters, patient-reported outcomes'], 'conditions': ['Hypertrophic Cardiomyopathy (HCM)']}, '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': 'COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice.', 'detailedDescription': 'The mavaCamten ObservationaL evIdence Global cOnsortium in hypertrophic cardiomyopathy (COLLIGO-HCM) is a global observational research initiative aiming to describe the real-world outcomes of treatments for obstructive hypertrophic cardiomyopathy (HCM), including mavacamten.\n\nThis retrospective study uses data from existing medical records and electronic registries from HCM centers around the world.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include adult patients who have been diagnosed with Hypertrophic Cardiomyopathy (HCM).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Source Cohort\n\n \\- Have at least one recorded encounter with a Hypertrophic Cardiomyopathy (HCM) diagnosis during or after 2018 (the first is defined as the index) and aged ≥18 years on the index date.\n\n \\- Disease-specific patient history documented in the medical record.\n* HCM Sub-Cohort\n\n \\- Participants in the source cohort with a known HCM diagnosis\n* Mavacamten Sub-Cohort - Participants who have their first mavacamten prescription after the index date\n\nExclusion Criteria:\n\n• HCM Sub-Cohort\n\n\\- HCM phenocopy (athlete's heart, hypertensive heart disease, Fabry disease, Pompe disease, Danon disease, amyloidosis) observed after the first observed HCM-associated encounter in the medical record."}, 'identificationModule': {'nctId': 'NCT06372457', 'acronym': 'COLLIGO-HCM', 'briefTitle': 'COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'mavaCamten ObservationaL evIdence Global cOnsortium in HCM (COLLIGO-HCM)', 'orgStudyIdInfo': {'id': 'CV027-1107'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Hypertrophic Cardiomyopathy (HCM)', 'description': 'Participants with an available HCM diagnosis date and without evidence of an HCM phenocopy', 'interventionNames': ['Drug: Approved Hypertrophic Cardiomyopathy drug treatments']}, {'label': 'Participants treated with mavacamten.', 'interventionNames': ['Drug: Mavacamten']}], 'interventions': [{'name': 'Approved Hypertrophic Cardiomyopathy drug treatments', 'type': 'DRUG', 'description': 'As per product label', 'armGroupLabels': ['Participants with Hypertrophic Cardiomyopathy (HCM)']}, {'name': 'Mavacamten', 'type': 'DRUG', 'description': 'As per product label', 'armGroupLabels': ['Participants treated with mavacamten.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27703', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'IQVIA', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], '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'}}}}