A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy (ODYSSEY-HCM)

July 29, 2026 updated by: Bristol-Myers Squibb

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

580

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Local Institution - 0063
      • Darlinghurst, New South Wales, Australia, 2010
        • Local Institution - 0085
      • Sydney, New South Wales, Australia, 2170
        • Local Institution - 0369
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Local Institution - 0080
      • Milton, Queensland, Australia, 4064
        • Local Institution - 0078
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Local Institution - 0050
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0076
  • Austria
      • Graz, Austria, 8036
        • Local Institution - 0062
      • Vienna, Austria, 1090
        • Local Institution - 0429
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Local Institution - 0090
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Local Institution - 0075
    • Upper Austria (Oberösterreich)
      • Braunau am Inn, Upper Austria (Oberösterreich), Austria, 5280
        • Local Institution - 0069
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Local Institution - 0462
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Local Institution - 0034
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Local Institution - 0476
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Local Institution - 0319
  • Brazil
      • Rio de Janeiro, Brazil, 22061-080
        • Local Institution - 0451
      • Rio de Janeiro, Brazil, 20551-030
        • Local Institution - 0446
      • São Paulo, Brazil, 04012-180
        • Local Institution - 0418
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40170-130
        • Local Institution - 0413
    • Federal District
      • Brasília, Federal District, Brazil, 70710-140
        • Local Institution - 0438
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30220-140
        • Local Institution - 0488
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
        • Local Institution - 0447
      • Porto Alegre, Rio Grande do Sul, Brazil, 90620-001
        • Local Institution - 0450
    • São Paulo
      • Bragança Paulista, São Paulo, Brazil, 12916-542
        • Local Institution - 0430
      • Ribeirão Preto, São Paulo, Brazil, 14026-900
        • Local Institution - 0422
      • São Paulo, São Paulo, Brazil, 05403-000
        • Local Institution - 0412
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Local Institution - 0381
    • British Columbia
      • Vancouver, British Columbia, Canada, V6E 1M7
        • Local Institution - 0467
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Local Institution - 0414
      • London, Ontario, Canada, N6A 5A5
        • Local Institution - 0411
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Local Institution - 0093
  • China
      • Beijing, China, 100730
        • Local Institution - 0502
      • Beijing, China, 102218
        • Local Institution - 0553
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100083
        • Local Institution - 0535
      • Beijing, Beijing Municipality, China, 100730
        • Local Institution - 0534
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Local Institution - 0503
      • Chongqing, Chongqing Municipality, China, 400016
        • Local Institution - 0541
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Local Institution - 0539
      • Guangzhou, Guangdong, China, 510515
        • Local Institution - 0543
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Local Institution - 0549
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Local Institution - 0542
    • Hunan
      • Changsha, Hunan, China, 410011
        • Local Institution - 0548
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Local Institution - 0545
    • Jiangxi
      • Nanchang, Jiangxi, China, 330008
        • Local Institution - 0550
    • Jilin
      • Changchun, Jilin, China, 130041
        • Local Institution - 0544
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Local Institution - 0540
      • Shenyang, Liaoning, China, 110016
        • Local Institution - 0501
      • Shenyang, Liaoning, China, 110016
        • Local Institution - 0538
    • Shan1xi
      • Xi'an, Shan1xi, China, 710061
        • Local Institution - 0547
    • Shandong
      • Jinan, Shandong, China, 250021
        • Local Institution - 0546
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Local Institution - 0537
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Local Institution - 0533
      • Chengdu, Sichuan, China, 610015
        • Local Institution - 0552
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Local Institution - 0536
  • Czechia
      • Brno, Czechia, 656 91
        • Local Institution - 0188
    • Hradec Králové Region
      • Broumov, Hradec Králové Region, Czechia, 550 01
        • Local Institution - 0086
    • Praha, Hlavní Mesto
      • Prague, Praha, Hlavní Mesto, Czechia, 140 21
        • Local Institution - 0033
      • Prague, Praha, Hlavní Mesto, Czechia, 128 21
        • Local Institution - 0052
  • Denmark
      • Aarhus N, Denmark, 8200
        • Local Institution - 0019
    • North Denmark
      • Aalborg, North Denmark, Denmark, DK-9000
        • Local Institution - 0045
    • Sønderjylland
      • Aabenraa, Sønderjylland, Denmark, 6200
        • Local Institution - 0428
  • France
      • Nantes, France, 44093
        • Local Institution - 0009
      • Paris, France, 75013
        • Local Institution - 0004
      • Paris, France, 75015
        • Local Institution - 0006
      • Pessac, France, 33604
        • Local Institution - 0053
      • Rennes, France, 35000
        • Local Institution - 0008
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06000
        • Local Institution - 0001
    • Finistère
      • Brest, Finistère, France, 29200
        • Local Institution - 0463
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31400
        • Local Institution - 0005
    • Indre-et-Loire
      • Chambray-lès-Tours, Indre-et-Loire, France, 37044
        • Local Institution - 0003
    • Isère
      • La Tronche, Isère, France, 38700
        • Local Institution - 0489
    • Rhône
      • Bron, Rhône, France, 69500
        • Local Institution - 0067
  • Germany
      • Berlin, Germany, 13353
        • Local Institution - 0403
      • Freiburg im Breisgau, Germany, 79106
        • Local Institution - 0071
      • Hamburg, Germany, 20246
        • Local Institution - 0032
      • Heidelberg, Germany, 69120
        • Local Institution - 0077
      • München, Germany, 80636
        • Local Institution - 0454
      • Münster, Germany, 48149
        • Local Institution - 0046
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Local Institution - 0404
    • Bavaria
      • München, Bavaria, Germany, 81377
        • Local Institution - 0022
      • Regensburg, Bavaria, Germany, 93053
        • Local Institution - 0440
    • Hesse
      • Bad Nauheim, Hesse, Germany, 61231
        • Local Institution - 0013
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Local Institution - 0496
      • Hanover, Lower Saxony, Germany, 30625
        • Local Institution - 0448
    • North Rhine Wesrphalia
      • Cologne, North Rhine Wesrphalia, Germany, 50924
        • Local Institution - 0273
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
        • Local Institution - 0439
      • Bielefeld, North Rhine-Westphalia, Germany, 33604
        • Local Institution - 0174
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Local Institution - 0420
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Local Institution - 0066
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Local Institution - 0016
  • Hungary
      • Budapest, Hungary, 1096
        • Local Institution - 0048
      • Budapest, Hungary, 1097
        • Local Institution - 0039
      • Budapest, Hungary, 1122
        • Local Institution - 0035
      • Szeged, Hungary, 6720
        • Local Institution - 0417
    • Veszprém megye
      • Balatonfüred, Veszprém megye, Hungary, 8230
        • Local Institution - 0423
  • India
      • Chandigarh, India, 160012
        • Local Institution - 0483
      • Gurgaon, India, 122 001
        • Local Institution - 0330
    • Gujarat
      • Ahmedabad, Gujarat, India, 380060
        • Local Institution - 0482
    • Karnataka
      • Bengaluru, Karnataka, India, 560099
        • Local Institution - 0480
    • Kerala
      • Kochi, Kerala, India, 682001
        • Local Institution - 0481
  • Israel
      • Haifa, Israel, 3109601
        • Local Institution - 0419
      • Petah Tikva, Israel, 49100
        • Local Institution - 0427
      • Ramat Gan, Israel, 5265601
        • Local Institution - 0074
      • Rehovot, Israel, 76100
        • Local Institution - 0054
      • Safed, Israel, 13100
        • Local Institution - 0253
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 90000
        • Local Institution - 0025
      • Jerusalem, Jerusalem, Israel, 9103102
        • Local Institution - 0057
    • Tel Aviv
      • Ashkelon, Tel Aviv, Israel, 7830604
        • Local Institution - 0026
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Local Institution - 0037
  • Italy
      • Pisa, Italy, 56124
        • Local Institution - 0171
      • Roma, Italy, 00189
        • Local Institution - 0028
    • Tuscany
      • Florence, Tuscany, Italy, 50139
        • Local Institution - 0373
  • Japan
      • Fukuoka, Japan, 810-0001
        • Local Institution - 0521
    • Ehime
      • Uwajima, Ehime, Japan, 798-8510
        • Local Institution - 0370
    • Hyōgo
      • Himeji-Shi, Hyōgo, Japan, 672-8044
        • Local Institution - 0208
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Local Institution - 0457
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 227-8501
        • Local Institution - 0107
    • Kochi
      • Nankoku-shi, Kochi, Japan, 783-8505
        • Local Institution - 0119
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Local Institution - 0453
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Local Institution - 0456
    • Osaka
      • Osaka, Osaka, Japan, 545-0051
        • Local Institution - 0452
      • Suita, Osaka, Japan, 564-8565
        • Local Institution - 0315
      • Takatsuki-Shi, Osaka, Japan, 569-8686
        • Local Institution - 0471
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Local Institution - 0168
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138603
        • Local Institution - 0477
      • Chuo-Ku, Tokyo, Japan, 104-0044
        • Local Institution - 0505
      • Itabashi-Ku, Tokyo, Japan, 173-0003
        • Local Institution - 0224
      • Koto-Ku, Tokyo, Japan, 135-0061
        • Local Institution - 0466
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Local Institution - 0314
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Local Institution - 0475
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Local Institution - 0061
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Local Institution - 0442
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Local Institution - 0434
    • North Holland
      • Amsterdam-Zuidoost, North Holland, Netherlands, 1105 AZ
        • Local Institution - 0197
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Local Institution - 0213
  • Norway
      • Lørenskog, Norway, 1478
        • Local Institution - 0443
      • Oslo, Norway, 0424
        • Local Institution - 0441
      • Trondheim, Norway, 7030
        • Local Institution - 0473
  • Poland
      • Bialystok, Poland, 15-276
        • Local Institution - 0030
      • Lódz, Poland, 93-338
        • Local Institution - 0416
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-202
        • Local Institution - 0042
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
        • Local Institution - 0038
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-981
        • Local Institution - 0091
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-097
        • Local Institution - 0338
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • Local Institution - 0203
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
        • Local Institution - 0072
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-555
        • Local Institution - 0017
      • Zabrze, Silesian Voivodeship, Poland, 41-800
        • Local Institution - 0415
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 91-347
        • Local Institution - 0059
  • Portugal
      • Almada, Portugal, 2805-267
        • Local Institution - 0015
      • Leiria, Portugal, 2410-197
        • Local Institution - 0433
      • Lisbon, Portugal, 1500-650
        • Local Institution - 0023
      • Lisbon, Portugal, 1649-035
        • Local Institution - 0024
      • Vila Nova de Gaia, Portugal, 4434-502
        • Local Institution - 0014
    • Braga District
      • Guimarães, Braga District, Portugal, 4835-044
        • Local Institution - 0044
  • South Korea
      • Busan, South Korea, 49241
        • Local Institution - 0517
      • Seongnam-si, South Korea
        • Local Institution - 0508
      • Seoul, South Korea, 03080
        • Local Institution - 0217
      • Seoul, South Korea, 05505
        • Local Institution - 0049
    • Daegu Gwang'yeogsi
      • Daegu, Daegu Gwang'yeogsi, South Korea, 42601
        • Local Institution - 0516
    • Incheon Gwang'yeogsi
      • Incheon, Incheon Gwang'yeogsi, South Korea, 22332
        • Local Institution - 0518
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Local Institution - 0012
      • Seoul, Seoul Teugbyeolsi, South Korea, 6351
        • Local Institution - 0055
      • Seoul, Seoul Teugbyeolsi, South Korea, 6591
        • Local Institution - 0460
  • Spain
      • A Coruña, Spain, 15006
        • Local Institution - 0043
      • Alicante, Spain, 03010
        • Local Institution - 0087
      • Barcelona, Spain, 08035
        • Local Institution - 0018
      • Barcelona, Spain, 08036
        • Local Institution - 0056
      • Granada, Spain, 18014
        • Local Institution - 0060
      • Madrid, Spain, 28034
        • Local Institution - 0421
      • Málaga, Spain, 29010
        • Local Institution - 0041
      • Salamanca, Spain, 37007
        • Local Institution - 0031
      • Seville, Spain, 41009
        • Local Institution - 0051
      • Valencia, Spain, 46026
        • Local Institution - 0027
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07198
        • Local Institution - 0040
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Local Institution - 0299
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Local Institution - 0021
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Local Institution - 0237
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Local Institution - 0407
      • London, United Kingdom, EC1A 7BE
        • Local Institution - 0472
    • Greater London
      • London, Greater London, United Kingdom, SW3 6NP
        • Local Institution - 0445
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G51 4TF
        • Local Institution - 0073
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-1900
        • Local Institution - 0082
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Local Institution - 0458
    • California
      • La Jolla, California, United States, 92037-1337
        • Local Institution - 0409
      • Los Angeles, California, United States, 90048-3311
        • Local Institution - 0010
      • San Francisco, California, United States, 94143-2204
        • Local Institution - 0406
      • Stanford, California, United States, 94305-2200
        • Local Institution - 0079
    • Florida
      • Gainesville, Florida, United States, 32608-1134
        • Local Institution - 0468
      • Tampa, Florida, United States, 33606-3603
        • Local Institution - 0281
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0092
    • Indiana
      • Indianapolis, Indiana, United States, 46202-1243
        • Local Institution - 0424
    • Iowa
      • Iowa City, Iowa, United States, 52242-1009
        • Local Institution - 0070
    • Kansas
      • Kansas City, Kansas, United States, 66160-8500
        • Local Institution - 0410
    • Kentucky
      • Louisville, Kentucky, United States, 40217-1363
        • Local Institution - 0484
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0127
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0479
      • Boston, Massachusetts, United States, 02118-2908
        • Local Institution - 0500
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 0464
      • Detroit, Michigan, United States, 48202-2608
        • Local Institution - 0064
      • Grand Rapids, Michigan, United States, 49525
        • Local Institution - 0455
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 0431
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0461
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2265
        • Local Institution - 0435
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Local Institution - 0490
    • New York
      • Manhasset, New York, United States, 11030-3816
        • Local Institution - 0449
      • New York, New York, United States, 10019-1147
        • Local Institution - 0486
      • Stony Brook, New York, United States, 11790-3407
        • Local Institution - 0007
      • Valhalla, New York, United States, 10595
        • Local Institution - 0426
    • North Carolina
      • Charlotte, North Carolina, United States, 28204-2826
        • Local Institution - 0094
      • Durham, North Carolina, United States, 27710
        • Local Institution - 0065
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0083
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Local Institution - 0047
      • Lancaster, Pennsylvania, United States, 17602-2250
        • Local Institution - 0444
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0263
      • Pittsburgh, Pennsylvania, United States, 15213-2536
        • Local Institution - 0081
    • Tennessee
      • Germantown, Tennessee, United States, 38138-1727
        • Local Institution - 0207
    • Texas
      • Dallas, Texas, United States, 75246
        • Local Institution - 0089
      • Dallas, Texas, United States, 75390
        • Local Institution - 0365
      • Plano, Texas, United States, 75093
        • Local Institution - 0492
    • Utah
      • Salt Lake City, Utah, United States, 84132-0001
        • Local Institution - 0402
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0001
        • Local Institution - 0478
      • Richmond, Virginia, United States, 23298-5024
        • Local Institution - 0095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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.
  • 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).
  • New York Heart Association (NYHA) Class II or III.

Exclusion Criteria

  • 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.
  • History of unexplained syncope within 6 months prior to screening.
  • History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days
Experimental: Mavacamten
Drug: Mavacamten
Specified dose on specified days
Other Names:
  • BMS-986427
  • MYK-461

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in KCCQ-23 CSS at Week 48
Time Frame: From First dose to week 48
The KCCQ-23 is a 23-item, self-administered questionnaire that measures the impact of a participant's cardiovascular disease or its treatment on 6 distinct domains using a 2-week recall period: symptoms/signs, physical limitation, quality of life (QoL), social limitations, self-efficacy, and symptom stability. The KCCQ 23 Clinical Summary Score (CSS) is derived from the Total Symptom Score (TSS) and the Physical Limitations (PL) score of the KCCQ 23. The CSS, TSS, and the PL score range from 0 to 100 with higher scores representing less severe symptoms and/or physical limitations. The CSS is a mean of the TSS and the PL score. Baseline is defined as the last non-missing assessment prior to the first dose of the study treatment if both the time of the measurement and the time of first dose are available otherwise it is the last non-missing assessment on or prior to the first dose of the study treatment.
From First dose to week 48
Change From Baseline in pVO2 at Week 48
Time Frame: From First dose to week 48
Clinically meaningful mean change from baseline(1.4ml/kg/min) of pVO2 at Week 48.
From First dose to week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in VE/VCO2 Slope at Week 48
Time Frame: From First dose to week 48
VE/VCO₂ slope was assessed using cardiopulmonary exercise testing (CPET). The slope was calculated as the linear regression of minute ventilation (VE) against carbon dioxide production (VCO₂). A decrease in VE/VCO₂ slope reflects improved ventilatory efficiency.
From First dose to week 48
Mean Change From Baseline in NT-proBNP to Week 48
Time Frame: From First dose to week 48
Blood samples were collected for assessing the concentration of NT-proBNP. Baseline is defined as last non-missing measurement prior to the first dose.
From First dose to week 48
Percentage of Participants With at Least 1 Class of NYHA Improvement From Baseline at Week 48
Time Frame: From First dose to week 48

Participants with \>= 1 NYHA function class improvement.

The NYHA Functional Classification of heart failure assigns participants to 1 of 4 categories based on the participant's symptoms.

Class 1: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

Class 2: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

Class 3: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

Class 4: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
From First dose to week 48
Mean Change From Baseline in HCMSQ SoB Domain Score at Week 48
Time Frame: From First dose to week 48

The HCMSQ is a self- administered, 9-item questionnaire that assesses the core symptoms of HCM (shortness of breath, tiredness/fatigue, heart palpitations, chest pain, dizziness, and syncope). At each visit, a 7-day period will be defined, ending on the last day with a non-missing HCMSQ score prior to the actual clinic visit (or first dose date if baseline). If the participant completes the HCMSQ for 4 or more days within this period, the weekly average HCMSQ score will be calculated. If fewer than 4 days are completed, other 7-day periods will be considered. For baseline, any 7-day period with at least 4 days of HCMSQ prior to the first dose or randomization date (if first dose date is missing) will be used.

Each domain of the SoB scale is scored 1 to 6. The scores are added together to give a total score. Lower scores indicating low to no shortness of breath, higher scores indicating frequent episodes of shortness of breath.

the lower the score the better.
From First dose to week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Actual)

March 6, 2025

Study Completion (Actual)

October 20, 2025

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

October 14, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV027-031
  • U1111-1269-8581 (Registry Identifier: WHO)
  • 2023-506352-24 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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