Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-03-27 @ 8:43 AM
Study NCT ID:
NCT05582395
Status:
COMPLETED
Last Update Posted:
2025-11-14
First Post:
2022-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 580}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-10-14', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48', 'timeFrame': 'Up to Week 48'}, {'measure': 'Change from baseline in peak oxygen consumption (pVO2) at Week 48', 'timeFrame': 'Up to Week 48'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in ventilatory efficiency (VE/VCO2) slope to Week 48', 'timeFrame': 'Up to Week 48'}, {'measure': 'Proportion of participants with at least 1 class of New York Heart Association (NYHA) improvement from baseline to Week 48', 'timeFrame': 'Up to Week 48'}, {'measure': 'Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) to Week 48', 'timeFrame': 'Up to Week 48'}, {'measure': 'Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48', 'timeFrame': 'Up to Week 48'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mavacamten', 'non-obstructive HCM', 'non-obstructive hypertrophic cardiomyopathy (nHCM)'], 'conditions': ['Cardiomyopathy, Hypertrophic']}, 'referencesModule': {'references': [{'pmid': '40888717', 'type': 'DERIVED', 'citation': 'Desai MY, Owens AT, Abraham T, Olivotto I, Garcia-Pavia P, Lopes RD, Elliott P, Fernandes F, Verheyen N, Maier L, Meder B, Azevedo O, Kitaoka H, Wolski K, Wang Q, Jaber W, Mitchell L, Myers J, Rano T, Gong Z, Zhong Y, Carter-Bonanza S, Florea V, Aronson R, Nissen SE; ODYSSEY-HCM Investigators. Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy. N Engl J Med. 2025 Sep 11;393(10):961-972. doi: 10.1056/NEJMoa2505927. Epub 2025 Aug 30.'}, {'pmid': '40864018', 'type': 'DERIVED', 'citation': 'Desai MY, Olivotto I, Abraham T, Nissen SE, Garcia-Pavia P, Lopes RD, Elliott PM, Fernandes F, de Barros Correia E, Barriales-Villa R, Zorio E, Arad M, Shin SH, Verheyen N, Meder B, Azevedo O, Kitaoka H, Wolski K, Wang Q, Suryawanshi B, Wang Z, Florea V, Aronson R, Owens AT; ODYSSEY-HCM Investigators. Effects of Mavacamten on Cardiac Biomarkers in Nonobstructive Hypertrophic Cardiomyopathy: Insights From the ODYSSEY-HCM Trial. J Am Coll Cardiol. 2025 Aug 25:S0735-1097(25)07431-5. doi: 10.1016/j.jacc.2025.08.017. Online ahead of print.'}, {'pmid': '39909647', 'type': 'DERIVED', 'citation': 'Desai MY, Nissen SE, Abraham T, Olivotto I, Garcia-Pavia P, Lopes RD, Verheyen N, Wever-Pinzon O, Wolski K, Jaber W, Mitchell L, Davey D, Myers J, Rano T, Bhatia V, Zhong Y, Carter-Bonanza S, Florea V, Aronson R, Owens AT; ODYSSEY-HCM Investigators. Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Design, Rationale, and Baseline Characteristics of ODYSSEY-HCM. JACC Heart Fail. 2025 Feb;13(2):358-370. doi: 10.1016/j.jchf.2024.11.013.'}, {'pmid': '38625800', 'type': 'DERIVED', 'citation': "O'Malley PA. Mavacamten (CAMZYOS) First-in-Class Small-Molecule Myosin Inhibitor for Treatment of Obstructive Hypertrophic Cardiomyopathy. Clin Nurse Spec. 2024 May-Jun 01;38(3):119-121. doi: 10.1097/NUR.0000000000000821. No abstract available."}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Diagnosis of HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines: unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the absence of other cardiac or systemic disease which can produce the required magnitude of hypertrophy of a maximal left ventricular (LV) wall thickness ≥ 15 millimeters (mm) (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy \\[HCM\\]) as determined by core laboratory interpretation.\n* Peak left ventricular outflow tract (LVOT) pressure gradient \\< 30 millimeters mercury (mm Hg) at rest and \\< 50 mm Hg with provocation (Valsalva maneuver and stress echocardiography).\n* New York Heart Association (NYHA) Class II or III.\n\nExclusion Criteria\n\n* Known infiltrative or storage disorder causing cardiac hypertrophy that mimics non-obstructive hypertrophic cardiomyopathy (nHCM) such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.\n* History of unexplained syncope within 6 months prior to screening.\n* History of sustained ventricular tachyarrhythmia (\\> 30 seconds) within 6 months prior to screening.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT05582395', 'acronym': 'ODYSSEY-HCM', 'briefTitle': 'A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy', 'orgStudyIdInfo': {'id': 'CV027-031'}, 'secondaryIdInfos': [{'id': 'U1111-1269-8581', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': '2023-506352-24', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mavacamten', 'interventionNames': ['Drug: Mavacamten']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Mavacamten', 'type': 'DRUG', 'otherNames': ['BMS-986427', 'MYK-461'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Mavacamten']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-1900', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution - 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