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A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

Study acronym: ODYSSEY-HCM
StatusTerminated
PhasePhase 3
Started2022-12-14
View on ClinicalTrials.gov ↗

Amendment history

The 49 most recent of 63 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-19
Reclassified as terminated (was completed)
Trial terminated: Trial terminated because of lack of efficacy in the short term acute phase
2026-07-29
Study Status, Participant Flow, Baseline Characteristics, Outcome Measures (Results) v62
Results first postednot stated→2026-08-20
2026-06-01
Study Status, Outcome Measures, Participant Flow, Outcome Measures (Results) v61
Secondary endpointsdetails revised at 1 of 4 entries
2026-04-17
Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results) v60
Secondary endpointsdetails revised at 1 of 4 entries
2026-03-03
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v59
Secondary endpoints4 entries, revised
Change fromFrom baselineBaseline in ventilatory efficiency (VE/VCO2) slopeSlope at Week 48 Mean Change From Baseline in NT-proBNP to Week 48 ProportionPercentage of participantsParticipants withWith at leastLeast 1 classClass of NewNYHA YorkImprovement HeartFrom AssociationBaseline (NYHA) improvement from baseline toat Week 48 Mean Change fromFrom baselineBaseline in N-terminalHCMSQ proSoB B-typeDomain natriureticScore peptide (NT-proBNP) toat Week 48 Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48
Primary endpoints2 entries, revised
Change fromFrom baselineBaseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48 Change fromFrom baselineBaseline in peak oxygen consumption (pVO2) at Week 48
Show 45 earlier versions
2025-11-13
Active, Not Recruiting→Completed Study Status, References v58
Trial statusActive, Not Recruiting→Completed
Completion dateestimated 2029-06-29→confirmed 2025-10-20
2025-05-21
Study Status, Study Design v57
Enrollment targetestimated 420→confirmed 580
2025-03-25
Study Status, Contacts/Locations v56
Primary completion dateestimated 2025-03-31→confirmed 2025-03-06
Completion date2025-03-31→2029-06-29
Study sites225→224
2024-10-24
Study Identification, Study Status, Outcome Measures, Contacts/Locations, References v55
Study sites220→225
Secondary endpoints6 to 4 entries
Change from baseline in cardiac troponin-T (cTn-T) to Week 48 Time to first major adverse cardiovascular events (MACE)-plus events
2024-06-06
Study Status, Contacts/Locations v54
Study sites219→220
2024-05-31
Study Status, Contacts/Locations v53
Study sites218→219
2024-05-16
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v52
Trial statusRecruiting→Active, Not Recruiting
Study sites214→218
2024-04-15
Study Status, Contacts/Locations v51
Study sites213→214
2024-03-29
Study Status, Contacts/Locations v50
Study sites211→213
2024-02-23
Study Status, Contacts/Locations v49
Study sites211 entries, revised
Baylor ScottUniversity Medical Center Medanta Heart Institute Narayana Institute of Cardiac Science Post Graduate Institute of Medical Education and White Research Institute(PGIMER) LocalInha InstitutionUniversity -Hospital Pusan 0330National University Hospital LocalSeoul InstitutionNational -University 0480 LocalBundang Institution - 0483 Local Institution - 0518 Local Institution - 0517 Local Institution - 0508Hospital
2024-02-15
Study Status, Contacts/Locations v48
Study sites531→211
2024-02-09
Study Status, Contacts/Locations v47
Study sites531 entries, revised
MedStarLocal Washington Hospital CenterInstitution - Cardiovascular Research Institute (CRI) South Florida Heart Institute Great Lakes Clinical Trials, LLC - Flourish - 5149 North Ashland Ave - PPDS Christ Hospital Physicians Heart & Vascular Center McGinnis Thoracic & Cardiovascular Associates - Greensburg0491 Local Institution - 00760529 Local Institution - 04500499 Local Institution - 04670493 Local Institution - 00930522 LocalFiona InstitutionStanley Hospital Fundação Universitária de Cardiologia St Paul's Hospital Institut Universitaire de Cardiologie et de Pneumologie de Quebec - 0052Uni [...] [...]
2024-02-05
Study Status, Eligibility, Contacts/Locations, References v46
Eligibility criteria+12 characters
Inclusion Criteria: Diagnosis of HCM consistent with current American College o [...] pathy [HCM]) as determined by core laboratory interpretation. Peak left ventricular outflow tract (LVOT) pressure gradien [...] provocation (Valsalva maneuver and stress echocardiography). New York Heart Association (NYHA) Class II or III. Exclusion Criteria: Known infiltrative or storage disorder causing cardiac hype [...] disease, amyloidosis, or Noonan syndrome with LV hypertrophy. History of unexplained syncope within 6 months prior to screening. History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months [...] [...]
Study sites531 entries, revised
BaptistLocal Health Medical CenterInstitution - Little Rock University of Rochester Medical Center - PPDS University of Rochester - Rochester General Hospital - PPDS University Hospitals Cleveland Medical Center - 11100 Euclid Ave St. Luke's University Health Network Virginia Mason Medical Center - 1100 9th Ave0507 Local Institution - 04220530 Local Institution - 03810523 Local Institution - 00050510 Local Institution - 04040020 Local Institution - 02080509 LocalCLINICOR InstitutionClinica Radiologica Ribeirao Preto University of Calgary Medicine Hôpital de Rangueil Universitätsklinikum Ulm Hy [...] [...]
2024-01-30
Study Status, Contacts/Locations v45
Study sites531 entries, revised
BethLocal IsraelInstitution Deaconess- 0465 Local Institution - 0513 Local Institution - 0469 Local Institution - 0514 Local Institution - 0512 St Vincent's Hospital Sydney Instituto Cardiopulmonar da Bahia Ltda Sygehus Sønderjylland Hôpital de la Pitié Salpétrière University Medicine Göttingen Germany Medizinische Hochschule Hannover [...] Medical Center - 330PPDS Shaare BrooklineZedek AveMedical Center BrighamOsaka Medical and WomensPharmaceutical University Hospital SaintSt. Luke's International Hospital Tokyo ofWomen's Kansas City ColumbiaMedical University MedicalHospital Saiseikai Center Abin [...] [...]
2024-01-18
Study Status, Contacts/Locations v44
Study sites531 entries, revised
LocalPrince InstitutionCharles -Hospital Hospital 0080 LocalUniversitario InstitutionVirgen -de 0041la Victoria
2024-01-17
Study Status, Contacts/Locations, References v43
Study sites531 entries, revised
Oregon Health and Science University Local Institution - 00690084 LocalA.ö. InstitutionKrankenhaus St. Josef Braunau GmbH Hôpital Erasme McMaster University - 0034Hamilton Health Sciences LocalInstitut InstitutionKlinicke A Experimentalni Mediciny Groupement Hospitalier EST University Clinic Regensburg Universitätsklinikum Jena Uniklinik Köln University Clinic Heidelberg Szegedi Tudomanyegyetem Szent-Gyorgyi 0414Albert Klinikai Kozpont LocalAzienda InstitutionOspedaliera -Universitaria 0033Careggi LocalKochi InstitutionMedical -School 0067Hospital LocalAkershus InstitutionUniversitetssykehus O [...] [...]
2024-01-08
Study Status, Contacts/Locations v42
Study sites531 entries, revised
LocalMedizinische InstitutionUniversitat Wien (Medical University of Vienna) NUPEC-Núcleo 0429de Pesquisa Clínica LocalLondon InstitutionHealth -Science 0488 LocalCentre InstitutionResearch - 0411Inc.
2024-01-05
Study Status, Contacts/Locations v41
Study sitesdetails revised at 2 of 531 sites
2024-01-04
Study Status, Contacts/Locations v40
Study sites530→531
2024-01-02
Study Status, Contacts/Locations v39
Study sites529→530
2023-12-14
Study Status, Contacts/Locations, References v38
Study sites526→529
2023-12-06
Study Status, Contacts/Locations v37
Study sites523→526
2023-12-03
Study Status, Contacts/Locations v36
Study sitesdetails revised at 4 of 523 sites
2023-12-01
Study Status, Contacts/Locations v35
Study sitesdetails revised at 3 of 523 sites
2023-11-29
Study Status, Contacts/Locations v34
Study sites521→523
2023-11-17
Study Status, Contacts/Locations v33
Study sitesdetails revised at 1 of 521 sites
2023-11-15
Study Status, Contacts/Locations v32
Study sites517→521
2023-11-13
Study Status, Contacts/Locations v31
Study sites517 entries, revised
UsfUSF Health South Tampa Center For Advanced Healthcare
2023-11-07
Study Status, Contacts/Locations v30
Study sites503→517
2023-10-24
Study Status, Contacts/Locations v29
Study sites220→503
2023-09-29
Study Status, Contacts/Locations v28
Study sites218→220
2023-09-26
Study Status, Contacts/Locations v27
Study sites211→218
2023-09-01
Study Status, Contacts/Locations v26
Study sites211 entries, revised
University ofOf Iowa Hospitals And Clinics
2023-08-30
Study Status, Contacts/Locations v25
Study sitesdetails revised at 3 of 211 sites
2023-08-25
Study Status, Contacts/Locations v24
Study sites208→211
2023-08-16
Study Status, Contacts/Locations v23
Study sites207→208
2023-07-27
Study Status, Contacts/Locations v22
Study sites206→207
2023-07-25
Study Status, Contacts/Locations v21
Study sitesdetails revised at 8 of 206 sites
2023-07-20
Study Status, Contacts/Locations v20
Study sites205→206
2023-07-19
Study Status, Contacts/Locations v19
Study sites202→205
2023-07-10
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 202 sites
2023-07-03
Study Identification, Study Status, Outcome Measures, Contacts/Locations v17
Secondary endpoints22 to 6 entries
Change from baseline in ventilatory efficiency (VE/VCO2) slope to Week 5248 Proportion of participants with at least 1 class of New Yor [...] Heart Association (NYHA) improvement from baseline to Week 52 Proportion of participants with (1) pVO2 ≥ 1.5 milliliter per kilogram per minute (mL/kg/min) and NYHA improvement ≥ 1; or (2) pVO2 ≥ 3 mL/kg/min and NYHA no worsening, from baseline to Week 5248 Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) to Week 5248 Change from baseline in cardiac troponin-T (cTn-T) to Week 5248 Change from baseline in hypertrophic cardiomyopathy [...] [...]
Primary endpoints2 entries, revised
Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 5248 Change from baseline in peak oxygen consumption (pVO2) at Week 5248
Study sitesdetails revised at 15 of 202 sites
2023-06-05
Study Status, Contacts/Locations v16
Study sitesdetails revised at 7 of 202 sites
2023-05-30
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 202 sites
2023-05-25
Study Status, Contacts/Locations v14
Study sitesdetails revised at 2 of 202 sites
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).
Trial Details
NCT Number NCT05582395
Lead Sponsor Bristol-Myers Squibb
Conditions Cardiomyopathy, Hypertrophic
Enrollment 580 participants
Start Date 2022-12-14
Primary Completion 2025-03-06 (estimated)
Study Completion 2025-10-20 (estimated)
Updated on ClinicalTrials.gov 2026-09-18