AzTrials
AzTrials

Cardiomyopathy, HypertrophicPhase 3ODYSSEY-HCMNCT05582395

A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

A Phase 3 study testing Mavacamten in people with Cardiomyopathy, Hypertrophic, run by Bristol-Myers Squibb at 224 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiomyopathy, Hypertrophic
What is being tested?
Mavacamten
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
580 participants
Where
224 sitesin 23 countries
Study dates
14 Dec 2022to 20 Oct 2025
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

224 sites in 23 countries.

224 sites in 23 countries

United States41 sites

  • Local Institution - 0464

    Ann Arbor, Michigan, 48109

  • Local Institution - 0092

    Atlanta, Georgia, 30322

  • Local Institution - 0127

    Baltimore, Maryland, 21287

  • Local Institution - 0082

    Birmingham, Alabama, 35233-1900

  • Local Institution - 0479

    Boston, Massachusetts, 02114

  • Local Institution - 0500

    Boston, Massachusetts, 02118-2908

  • Local Institution - 0094

    Charlotte, North Carolina, 28204-2826

  • Local Institution - 0478

    Charlottesville, Virginia, 22908-0001

  • Local Institution - 0083

    Cleveland, Ohio, 44195

  • Local Institution - 0089

    Dallas, Texas, 75246

  • Local Institution - 0365

    Dallas, Texas, 75390

  • Local Institution - 0064

    Detroit, Michigan, 48202-2608

  • Local Institution - 0065

    Durham, North Carolina, 27710

  • Local Institution - 0468

    Gainesville, Florida, 32608-1134

  • Local Institution - 0207

    Germantown, Tennessee, 38138-1727

  • Local Institution - 0455

    Grand Rapids, Michigan, 49525

  • Local Institution - 0047

    Hershey, Pennsylvania, 17033

  • Local Institution - 0424

    Indianapolis, Indiana, 46202-1243

  • Local Institution - 0070

    Iowa City, Iowa, 52242-1009

  • Local Institution - 0410

    Kansas City, Kansas, 66160-8500

  • Local Institution - 0409

    La Jolla, California, 92037-1337

  • Local Institution - 0444

    Lancaster, Pennsylvania, 17602-2250

  • Local Institution - 0010

    Los Angeles, California, 90048-3311

  • Local Institution - 0484

    Louisville, Kentucky, 40217-1363

  • Local Institution - 0449

    Manhasset, New York, 11030-3816

  • Local Institution - 0490

    Morristown, New Jersey, 07962

  • Local Institution - 0486

    New York, New York, 10019-1147

  • Local Institution - 0435

    Omaha, Nebraska, 68198-2265

  • Local Institution - 0263

    Philadelphia, Pennsylvania, 19104

  • Local Institution - 0458

    Phoenix, Arizona, 85054

  • Local Institution - 0081

    Pittsburgh, Pennsylvania, 15213-2536

  • Local Institution - 0492

    Plano, Texas, 75093

  • Local Institution - 0095

    Richmond, Virginia, 23298-5024

  • Local Institution - 0431

    Rochester, Minnesota, 55905

  • Local Institution - 0402

    Salt Lake City, Utah, 84132-0001

  • Local Institution - 0406

    San Francisco, California, 94143-2204

  • Local Institution - 0461

    St Louis, Missouri, 63110

  • Local Institution - 0079

    Stanford, California, 94305-2200

  • Local Institution - 0007

    Stony Brook, New York, 11790-3407

  • Local Institution - 0281

    Tampa, Florida, 33606-3603

  • Local Institution - 0426

    Valhalla, New York, 10595

Other trials in United States

China23 sites

  • Local Institution - 0535

    Beijing, Beijing Municipality, 100083

  • Local Institution - 0534

    Beijing, Beijing Municipality, 100730

  • Local Institution - 0502

    Beijing, 100730

  • Local Institution - 0553

    Beijing, 102218

  • Local Institution - 0544

    Changchun, Jilin, 130041

  • Local Institution - 0548

    Changsha, Hunan, 410011

  • Local Institution - 0533

    Chengdu, Sichuan, 610000

  • Local Institution - 0552

    Chengdu, Sichuan, 610015

  • Local Institution - 0503

    Chongqing, Chongqing Municipality, 400016

  • Local Institution - 0541

    Chongqing, Chongqing Municipality, 400016

  • Local Institution - 0540

    Dalian, Liaoning, 116011

  • Local Institution - 0539

    Guangzhou, Guangdong, 510120

  • Local Institution - 0543

    Guangzhou, Guangdong, 510515

  • Local Institution - 0546

    Jinan, Shandong, 250021

  • Local Institution - 0550

    Nanchang, Jiangxi, 330008

  • Local Institution - 0537

    Shanghai, Shanghai Municipality, 200127

  • Local Institution - 0501

    Shenyang, Liaoning, 110016

  • Local Institution - 0538

    Shenyang, Liaoning, 110016

  • Local Institution - 0545

    Suzhou, Jiangsu, 215006

  • Local Institution - 0536

    Wenzhou, Zhejiang, 325000

  • Local Institution - 0542

    Wuhan, Hubei, 430060

  • Local Institution - 0547

    Xi'an, Shan1xi, 710061

  • Local Institution - 0549

    Zhengzhou, Henan, 450003

Other trials in China

Germany18 sites

  • Local Institution - 0013

    Bad Nauheim, Hesse, 61231

  • Local Institution - 0439

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • Local Institution - 0403

    Berlin, 13353

  • Local Institution - 0174

    Bielefeld, North Rhine-Westphalia, 33604

  • Local Institution - 0273

    Cologne, North Rhine Wesrphalia, 50924

  • Local Institution - 0071

    Freiburg im Breisgau, 79106

  • Local Institution - 0496

    Göttingen, Lower Saxony, 37075

  • Local Institution - 0032

    Hamburg, 20246

  • Local Institution - 0448

    Hanover, Lower Saxony, 30625

  • Local Institution - 0077

    Heidelberg, 69120

  • Local Institution - 0016

    Jena, Thuringia, 07747

  • Local Institution - 0066

    Lübeck, Schleswig-Holstein, 23538

  • Local Institution - 0420

    Mainz, Rhineland-Palatinate, 55131

  • Local Institution - 0022

    München, Bavaria, 81377

  • Local Institution - 0454

    München, 80636

  • Local Institution - 0046

    Münster, 48149

  • Local Institution - 0440

    Regensburg, Bavaria, 93053

  • Local Institution - 0404

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Japan18 sites

  • Local Institution - 0477

    Bunkyo-ku, Tokyo, 1138603

  • Local Institution - 0505

    Chuo-Ku, Tokyo, 104-0044

  • Local Institution - 0521

    Fukuoka, 810-0001

  • Local Institution - 0168

    Hamamatsu, Shizuoka, 431-3192

  • Local Institution - 0208

    Himeji-Shi, Hyōgo, 672-8044

  • Local Institution - 0224

    Itabashi-Ku, Tokyo, 173-0003

  • Local Institution - 0457

    Kanazawa, Ishikawa-ken, 920-8641

  • Local Institution - 0466

    Koto-Ku, Tokyo, 135-0061

  • Local Institution - 0119

    Nankoku-shi, Kochi, 783-8505

  • Local Institution - 0452

    Osaka, Osaka, 545-0051

  • Local Institution - 0456

    Sendai, Miyagi, 980-8574

  • Local Institution - 0314

    Shinjuku-ku, Tokyo, 160-8582

  • Local Institution - 0475

    Shinjuku-ku, Tokyo, 162-8666

  • Local Institution - 0315

    Suita, Osaka, 564-8565

  • Local Institution - 0471

    Takatsuki-Shi, Osaka, 569-8686

  • Local Institution - 0453

    Tsu, Mie-ken, 514-8507

  • Local Institution - 0370

    Uwajima, Ehime, 798-8510

  • Local Institution - 0107

    Yokohama, Kanagawa, 227-8501

Other trials in Japan

Spain14 sites

  • Local Institution - 0043

    A Coruña, 15006

  • Local Institution - 0087

    Alicante, 03010

  • Local Institution - 0018

    Barcelona, 08035

  • Local Institution - 0056

    Barcelona, 08036

  • Local Institution - 0237

    El Palmar, Murcia, 30120

  • Local Institution - 0060

    Granada, 18014

  • Local Institution - 0299

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Local Institution - 0421

    Madrid, 28034

  • Local Institution - 0021

    Majadahonda, Madrid, 28222

  • Local Institution - 0041

    Málaga, 29010

  • Local Institution - 0040

    Palma de Mallorca, Balearic Islands, 07198

  • Local Institution - 0031

    Salamanca, 37007

  • Local Institution - 0051

    Seville, 41009

  • Local Institution - 0027

    Valencia, 46026

Other trials in Spain

Brazil11 sites

  • Local Institution - 0488

    Belo Horizonte, Minas Gerais, 30220-140

  • Local Institution - 0430

    Bragança Paulista, São Paulo, 12916-542

  • Local Institution - 0438

    Brasília, Federal District, 70710-140

  • Local Institution - 0447

    Porto Alegre, Rio Grande do Sul, 90560-030

  • Local Institution - 0450

    Porto Alegre, Rio Grande do Sul, 90620-001

  • Local Institution - 0422

    Ribeirão Preto, São Paulo, 14026-900

  • Local Institution - 0446

    Rio de Janeiro, 20551-030

  • Local Institution - 0451

    Rio de Janeiro, 22061-080

  • Local Institution - 0413

    Salvador, Estado de Bahia, 40170-130

  • Local Institution - 0412

    São Paulo, São Paulo, 05403-000

  • Local Institution - 0418

    São Paulo, 04012-180

Other trials in Brazil

France11 sites

  • Local Institution - 0463

    Brest, Finistère, 29200

  • Local Institution - 0067

    Bron, Rhône, 69500

  • Local Institution - 0003

    Chambray-lès-Tours, Indre-et-Loire, 37044

  • Local Institution - 0489

    La Tronche, Isère, 38700

  • Local Institution - 0009

    Nantes, 44093

  • Local Institution - 0001

    Nice, Alpes-Maritimes, 06000

  • Local Institution - 0004

    Paris, 75013

  • Local Institution - 0006

    Paris, 75015

  • Local Institution - 0053

    Pessac, 33604

  • Local Institution - 0008

    Rennes, 35000

  • Local Institution - 0005

    Toulouse, Haute-Garonne, 31400

Other trials in France

Poland11 sites

  • Local Institution - 0030

    Bialystok, 15-276

  • Local Institution - 0017

    Katowice, Silesian Voivodeship, 40-555

  • Local Institution - 0042

    Krakow, Lesser Poland Voivodeship, 31-202

  • Local Institution - 0059

    Lodz, Łódź Voivodeship, 91-347

  • Local Institution - 0416

    Lódz, 93-338

  • Local Institution - 0072

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Local Institution - 0338

    Warsaw, Masovian Voivodeship, 02-097

  • Local Institution - 0203

    Warsaw, Masovian Voivodeship, 02-507

  • Local Institution - 0038

    Wroclaw, Lower Silesian Voivodeship, 50-556

  • Local Institution - 0091

    Wroclaw, Lower Silesian Voivodeship, 50-981

  • Local Institution - 0415

    Zabrze, Silesian Voivodeship, 41-800

Other trials in Poland

Israel9 sites

  • Local Institution - 0026

    Ashkelon, Tel Aviv, 7830604

  • Local Institution - 0419

    Haifa, 3109601

  • Local Institution - 0025

    Jerusalem, Jerusalem, 90000

  • Local Institution - 0057

    Jerusalem, Jerusalem, 9103102

  • Local Institution - 0427

    Petah Tikva, 49100

  • Local Institution - 0074

    Ramat Gan, 5265601

  • Local Institution - 0054

    Rehovot, 76100

  • Local Institution - 0253

    Safed, 13100

  • Local Institution - 0037

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

South Korea9 sites

  • Local Institution - 0517

    Busan, 49241

  • Local Institution - 0516

    Daegu, Daegu Gwang'yeogsi, 42601

  • Local Institution - 0518

    Incheon, Incheon Gwang'yeogsi, 22332

  • Local Institution - 0508

    Seongnam-si, 0

  • Local Institution - 0012

    Seoul, Seoul Teugbyeolsi, 03722

  • Local Institution - 0055

    Seoul, Seoul Teugbyeolsi, 6351

  • Local Institution - 0460

    Seoul, Seoul Teugbyeolsi, 6591

  • Local Institution - 0217

    Seoul, 03080

  • Local Institution - 0049

    Seoul, 05505

Other trials in South Korea

Australia7 sites

  • Local Institution - 0050

    Bedford Park, South Australia, 5042

  • Local Institution - 0080

    Chermside, Queensland, 4032

  • Local Institution - 0063

    Concord, New South Wales, 2139

  • Local Institution - 0085

    Darlinghurst, New South Wales, 2010

  • Local Institution - 0078

    Milton, Queensland, 4064

  • Local Institution - 0076

    Murdoch, Western Australia, 6150

  • Local Institution - 0369

    Sydney, New South Wales, 2170

Other trials in Australia

Portugal6 sites

  • Local Institution - 0015

    Almada, 2805-267

  • Local Institution - 0044

    Guimarães, Braga District, 4835-044

  • Local Institution - 0433

    Leiria, 2410-197

  • Local Institution - 0023

    Lisbon, 1500-650

  • Local Institution - 0024

    Lisbon, 1649-035

  • Local Institution - 0014

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Austria5 sites

  • Local Institution - 0069

    Braunau am Inn, Upper Austria (Oberösterreich), 5280

  • Local Institution - 0062

    Graz, 8036

  • Local Institution - 0090

    Innsbruck, Tyrol, 6020

  • Local Institution - 0075

    Linz, Upper Austria, 4020

  • Local Institution - 0429

    Vienna, 1090

Other trials in Austria

Canada5 sites

  • Local Institution - 0381

    Calgary, Alberta, T2N 1N4

  • Local Institution - 0414

    Hamilton, Ontario, L8L 2X2

  • Local Institution - 0411

    London, Ontario, N6A 5A5

  • Local Institution - 0093

    Québec, Quebec, G1V 4G5

  • Local Institution - 0467

    Vancouver, British Columbia, V6E 1M7

Other trials in Canada

Hungary5 sites

  • Local Institution - 0423

    Balatonfüred, Veszprém megye, 8230

  • Local Institution - 0048

    Budapest, 1096

  • Local Institution - 0039

    Budapest, 1097

  • Local Institution - 0035

    Budapest, 1122

  • Local Institution - 0417

    Szeged, 6720

Other trials in Hungary

India5 sites

  • Local Institution - 0482

    Ahmedabad, Gujarat, 380060

  • Local Institution - 0480

    Bengaluru, Karnataka, 560099

  • Local Institution - 0483

    Chandigarh, 160012

  • Local Institution - 0330

    Gūrgaon, 122 001

  • Local Institution - 0481

    Kochi, Kerala, 682001

Other trials in India

Netherlands5 sites

  • Local Institution - 0197

    Amsterdam-Zuidoost, North Holland, 1105 AZ

  • Local Institution - 0434

    Maastricht, Limburg, 6229 HX

  • Local Institution - 0442

    Nijmegen, Gelderland, 6525 GA

  • Local Institution - 0213

    Rotterdam, South Holland, 3015 GD

  • Local Institution - 0061

    Utrecht, 3584 CX

Other trials in Netherlands

Belgium4 sites

  • Local Institution - 0034

    Anderlecht, Brussels Capital, 1070

  • Local Institution - 0462

    Edegem, Antwerpen, 2650

  • Local Institution - 0476

    Genk, Limburg, 3600

  • Local Institution - 0319

    Leuven, Vlaams Brabant, 3000

Other trials in Belgium

Czechia4 sites

  • Local Institution - 0188

    Brno, 656 91

  • Local Institution - 0086

    Broumov, Hradec Králové Region, 550 01

  • Local Institution - 0052

    Prague, Praha, Hlavní Mesto, 128 21

  • Local Institution - 0033

    Prague, Praha, Hlavní Mesto, 140 21

Other trials in Czechia

United Kingdom4 sites

  • Local Institution - 0407

    Birmingham, B15 2TH

  • Local Institution - 0073

    Glasgow, Lanarkshire, G51 4TF

  • Local Institution - 0445

    London, Greater London, SW3 6NP

  • Local Institution - 0472

    London, EC1A 7BE

Other trials in United Kingdom

Denmark3 sites

  • Local Institution - 0428

    Aabenraa, Sønderjylland, 6200

  • Local Institution - 0045

    Aalborg, North Denmark, DK-9000

  • Local Institution - 0019

    Aarhus N, 8200

Other trials in Denmark

Italy3 sites

  • Local Institution - 0373

    Florence, Tuscany, 50139

  • Local Institution - 0171

    Pisa, 56124

  • Local Institution - 0028

    Roma, 00189

Other trials in Italy

Norway3 sites

  • Local Institution - 0443

    Lørenskog, 1478

  • Local Institution - 0441

    Oslo, 0424

  • Local Institution - 0473

    Trondheim, 7030

Other trials in Norway

About this study

Official title: 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).

Being tested
Mavacamten, Placebo
Keywords
Mavacamten, non-obstructive HCM, non-obstructive hypertrophic cardiomyopathy (nHCM)
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MavacamtenDrug

    Also called BMS-986427, MYK-461

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT05582395
Study groupRoleWhat they receive
MavacamtenExperimentalNot described
Receives: Drug: Mavacamten
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in KCCQ-23 CSS at 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.

    Measured: From First dose to week 48

  2. Change From Baseline in pVO2 at Week 48

    Clinically meaningful mean change from baseline(1.4ml/kg/min) of pVO2 at Week 48.

    Measured: From First dose to week 48

Secondary outcomes (4)

  1. Change From Baseline in VE/VCO2 Slope at 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.

    Measured: From First dose to week 48

  2. Mean Change From Baseline in NT-proBNP 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.

    Measured: From First dose to week 48

  3. Percentage of Participants With at Least 1 Class of NYHA Improvement From Baseline at 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.

    Measured: From First dose to week 48

  4. Mean Change From Baseline in HCMSQ SoB Domain Score at 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.

    Measured: From First dose to week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2022
  2. Study start14 Dec 2022
  3. Primary completion6 Mar 2025
  4. Study completion20 Oct 2025

Why it stopped: Trial terminated because of lack of efficacy in the short term acute phase

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
580 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05582395
Sponsor's protocol ID
CV027-031
Other IDs
U1111-1269-8581, 2023-506352-24, 2023
Acronym
ODYSSEY-HCM
Status last verified
Aug 2026
First submitted
14 Sep 2022
Last updated
18 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 40888717

  • 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 Dec 16;86(24):2418-2433. doi: 10.1016/j.jacc.2025.08.017. Epub 2025 Aug 27.

    PubMed 40864018

  • Sikand N, Stendahl J, Sen S, Lampert R, Day S. Current management of hypertrophic cardiomyopathy. BMJ. 2025 May 27;389:e077274. doi: 10.1136/bmj-2023-077274.

    PubMed 40425241

  • 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.

    PubMed 39909647

  • 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.

    PubMed 38625800

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