protocolSection identificationModule nctId: NCT06372457, orgStudyIdInfo id: CV027-1107, briefTitle: COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM), acronym: COLLIGO-HCM, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice., conditionsModule conditions: Hypertrophic Cardiomyopathy (HCM), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Approved Hypertrophic Cardiomyopathy drug treatments, interventions name: Mavacamten, outcomesModule primaryOutcomes measure: Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Participant age at mavacamten treatment initiation, primaryOutcomes measure: Participant sex, primaryOutcomes measure: Participant race/ethnicity, primaryOutcomes measure: Participant insurance coverage, primaryOutcomes measure: Participant employment status, primaryOutcomes measure: Participant educational level, primaryOutcomes measure: Date of Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis, primaryOutcomes measure: Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Participant New York Heart Association (NYHA) class, primaryOutcomes measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Participant height, primaryOutcomes measure: Participant weight, primaryOutcomes measure: Participant blood pressure, primaryOutcomes measure: Participant heart rate, primaryOutcomes measure: Participant Hypertrophic Cardiomyopathy (HCM) symptoms, primaryOutcomes measure: European participant CYP2C19 genotype, primaryOutcomes measure: Participant family history of Hypertrophic Cardiomyopathy (HCM), primaryOutcomes measure: Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM), primaryOutcomes measure: Participant family history of sudden cardiac death (SCD), primaryOutcomes measure: Participant smoking status, primaryOutcomes measure: Participant alcohol use, primaryOutcomes measure: Participant recreational drug use, primaryOutcomes measure: Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT), primaryOutcomes measure: Participant cardiovascular (CV) and CV-related comorbidities, primaryOutcomes measure: Participant non-cardiovascular (CV)-related comorbidities, primaryOutcomes measure: Participant electrocardiogram (ECG) rhythm results, primaryOutcomes measure: Participant cardiac magnetic resonance imaging (MRI) results, primaryOutcomes measure: Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results, primaryOutcomes measure: Participant cardiac troponin results, primaryOutcomes measure: Participant cardiopulmonary exercise test (CPET) results, primaryOutcomes measure: Participant cardiac monitoring results, primaryOutcomes measure: Participant exercise test results, primaryOutcomes measure: Participant blood creatine levels, primaryOutcomes measure: Participant cardiovascular (CV) events, primaryOutcomes measure: Type of procedures received by participants, primaryOutcomes measure: Cardiovascular treatments prescribed to participants, primaryOutcomes measure: Date of mavacamten prescription, primaryOutcomes measure: Date of mavacamten treatment initiation, primaryOutcomes measure: Date of mavacamten dosage change, primaryOutcomes measure: Reason for mavacamten dosage change, primaryOutcomes measure: Occurrence of mavacamten stable dose (a period of 6-months with the same dose), primaryOutcomes measure: Dates of follow-up after mavacamten treatment initiation, primaryOutcomes measure: Date of mavacamten treatment interuption or discontinuation, primaryOutcomes measure: Reason for mavacamten treatment interuption or discontinuation, primaryOutcomes measure: Supportive care provided to participants, primaryOutcomes measure: Heath care resource utilization (HCRU), primaryOutcomes measure: Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation, secondaryOutcomes measure: Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms, secondaryOutcomes measure: Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM), secondaryOutcomes measure: Participant family history of sudden cardiac death (SCD), secondaryOutcomes measure: Cardiovascular (CV) and CV-related comorbidities, secondaryOutcomes measure: Non-cardiovascular (non-CV) comorbidities, secondaryOutcomes measure: Participant electrocardiogram (ECG) rhythm results, secondaryOutcomes measure: Participant echocardiogram (ECHO) results, secondaryOutcomes measure: Participant cardiac MRI results, secondaryOutcomes measure: Participant NT-proBNP results, secondaryOutcomes measure: Participant cardiac tropin results, secondaryOutcomes measure: Participant cardiopulmonary exercise test (CPET) results, secondaryOutcomes measure: Participant cardiac monitoring results, secondaryOutcomes measure: Participant exercise test results, secondaryOutcomes measure: Hypertrophic Cardiomyopathy (HCM) subtype, secondaryOutcomes measure: Participant symptoms at Hypertrophic Cardiomyopathy (HCM), secondaryOutcomes measure: Participant New York Heart Association (NYHA) class, secondaryOutcomes measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis, secondaryOutcomes measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IQVIA, city: Durham, state: North Carolina, zip: 27703, country: United States, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False