A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

NCT ID: NCT05582395

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 580 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2025-10-20

Brief 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).

Conditions

Cardiomyopathy, Hypertrophic

Keywords

Mavacamten; non-obstructive HCM; non-obstructive hypertrophic cardiomyopathy (nHCM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mavacamten

Group Type: EXPERIMENTAL

Mavacamten

Intervention Type: DRUG

Specified dose on specified days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Specified dose on specified days

Interventions

Mavacamten

Specified dose on specified days

Intervention Type: DRUG

Placebo

Specified dose on specified days

Intervention Type: OTHER

Other Intervention Names

BMS-986427; MYK-461

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 0082

Birmingham, Alabama, United States

Local Institution - 0458

Phoenix, Arizona, United States

Local Institution - 0409

La Jolla, California, United States

Local Institution - 0010

Los Angeles, California, United States

Local Institution - 0406

San Francisco, California, United States

Local Institution - 0079

Stanford, California, United States

Local Institution - 0468

Gainesville, Florida, United States

Local Institution - 0281

Tampa, Florida, United States

Local Institution - 0092

Atlanta, Georgia, United States

Local Institution - 0424

Indianapolis, Indiana, United States

Local Institution - 0070

Iowa City, Iowa, United States

Local Institution - 0410

Kansas City, Kansas, United States

Local Institution - 0484

Louisville, Kentucky, United States

Local Institution - 0127

Baltimore, Maryland, United States

Local Institution - 0479

Boston, Massachusetts, United States

Local Institution - 0500

Boston, Massachusetts, United States

Local Institution - 0464

Ann Arbor, Michigan, United States

Local Institution - 0064

Detroit, Michigan, United States

Local Institution - 0455

Grand Rapids, Michigan, United States

Local Institution - 0431

Rochester, Minnesota, United States

Local Institution - 0461

St Louis, Missouri, United States

Local Institution - 0435

Omaha, Nebraska, United States

Local Institution - 0490

Morristown, New Jersey, United States

Local Institution - 0449

Manhasset, New York, United States

Local Institution - 0486

New York, New York, United States

Local Institution - 0007

Stony Brook, New York, United States

Local Institution - 0426

Valhalla, New York, United States

Local Institution - 0094

Charlotte, North Carolina, United States

Local Institution - 0065

Durham, North Carolina, United States

Local Institution - 0083

Cleveland, Ohio, United States

Local Institution - 0047

Hershey, Pennsylvania, United States

Local Institution - 0444

Lancaster, Pennsylvania, United States

Local Institution - 0263

Philadelphia, Pennsylvania, United States

Local Institution - 0081

Pittsburgh, Pennsylvania, United States

Local Institution - 0207

Germantown, Tennessee, United States

Local Institution - 0089

Dallas, Texas, United States

Local Institution - 0365

Dallas, Texas, United States

Local Institution - 0492

Plano, Texas, United States

Local Institution - 0402

Salt Lake City, Utah, United States

Local Institution - 0478

Charlottesville, Virginia, United States

Local Institution - 0095

Richmond, Virginia, United States

Local Institution - 0063

Concord, New South Wales, Australia

Local Institution - 0085

Darlinghurst, New South Wales, Australia

Local Institution - 0369

Sydney, New South Wales, Australia

Local Institution - 0080

Chermside, Queensland, Australia

Local Institution - 0078

Milton, Queensland, Australia

Local Institution - 0050

Bedford Park, South Australia, Australia

Local Institution - 0076

Murdoch, Western Australia, Australia

Local Institution - 0090

Innsbruck, Tyrol, Austria

Local Institution - 0075

Linz, Upper Austria, Austria

Local Institution - 0069

Braunau am Inn, Upper Austria (Oberösterreich), Austria

Local Institution - 0062

Graz, , Austria

Local Institution - 0429

Vienna, , Austria

Local Institution - 0462

Edegem, Antwerpen, Belgium

Local Institution - 0034

Anderlecht, Brussels Capital, Belgium

Local Institution - 0476

Genk, Limburg, Belgium

Local Institution - 0319

Leuven, Vlaams Brabant, Belgium

Local Institution - 0413

Salvador, Estado de Bahia, Brazil

Local Institution - 0438

Brasília, Federal District, Brazil

Local Institution - 0488

Belo Horizonte, Minas Gerais, Brazil

Local Institution - 0447

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0450

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0430

Bragança Paulista, São Paulo, Brazil

Local Institution - 0422

Ribeirão Preto, São Paulo, Brazil

Local Institution - 0412

São Paulo, São Paulo, Brazil

Local Institution - 0446

Rio de Janeiro, , Brazil

Local Institution - 0451

Rio de Janeiro, , Brazil

Local Institution - 0418

São Paulo, , Brazil

Local Institution - 0381

Calgary, Alberta, Canada

Local Institution - 0467

Vancouver, British Columbia, Canada

Local Institution - 0414

Hamilton, Ontario, Canada

Local Institution - 0411

London, Ontario, Canada

Local Institution - 0093

Québec, Quebec, Canada

Local Institution - 0535

Beijing, Beijing Municipality, China

Local Institution - 0534

Beijing, Beijing Municipality, China

Local Institution - 0503

Chongqing, Chongqing Municipality, China

Local Institution - 0541

Chongqing, Chongqing Municipality, China

Local Institution - 0539

Guangzhou, Guangdong, China

Local Institution - 0543

Guangzhou, Guangdong, China

Local Institution - 0549

Zhengzhou, Henan, China

Local Institution - 0542

Wuhan, Hubei, China

Local Institution - 0548

Changsha, Hunan, China

Local Institution - 0545

Suzhou, Jiangsu, China

Local Institution - 0550

Nanchang, Jiangxi, China

Local Institution - 0544

Changchun, Jilin, China

Local Institution - 0540

Dalian, Liaoning, China

Local Institution - 0501

Shenyang, Liaoning, China

Local Institution - 0538

Shenyang, Liaoning, China

Local Institution - 0547

Xi'an, Shan1xi, China

Local Institution - 0546

Jinan, Shandong, China

Local Institution - 0537

Shanghai, Shanghai Municipality, China

Local Institution - 0533

Chengdu, Sichuan, China

Local Institution - 0552

Chengdu, Sichuan, China

Local Institution - 0536

Wenzhou, Zhejiang, China

Local Institution - 0502

Beijing, , China

Local Institution - 0553

Beijing, , China

Local Institution - 0086

Broumov, Královéhradecký kraj, Czechia

Local Institution - 0052

Prague, Praha, Hlavní Mesto, Czechia

Local Institution - 0033

Prague, Praha, Hlavní Mesto, Czechia

Local Institution - 0188

Brno, , Czechia

Local Institution - 0045

Aalborg, North Denmark, Denmark

Local Institution - 0428

Aabenraa, Sønderjylland, Denmark

Local Institution - 0019

Aarhus N, , Denmark

Local Institution - 0001

Nice, Alpes-Maritimes, France

Local Institution - 0463

Brest, Finistère, France

Local Institution - 0005

Toulouse, Haute-Garonne, France

Local Institution - 0003

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

Local Institution - 0489

La Tronche, Isère, France

Local Institution - 0067

Bron, Rhône, France

Local Institution - 0009

Nantes, , France

Local Institution - 0004

Paris, , France

Local Institution - 0006

Paris, , France

Local Institution - 0053

Pessac, , France

Local Institution - 0008

Rennes, , France

Local Institution - 0404

Ulm, Baden-Wurttemberg, Germany

Local Institution - 0022

München, Bavaria, Germany

Local Institution - 0440

Regensburg, Bavaria, Germany

Local Institution - 0013

Bad Nauheim, Hesse, Germany

Local Institution - 0496

Göttingen, Lower Saxony, Germany

Local Institution - 0448

Hanover, Lower Saxony, Germany

Local Institution - 0273

Cologne, North Rhine Wesrphalia, Germany

Local Institution - 0439

Bad Oeynhausen, North Rhine-Westphalia, Germany

Local Institution - 0174

Bielefeld, North Rhine-Westphalia, Germany

Local Institution - 0420

Mainz, Rhineland-Palatinate, Germany

Local Institution - 0066

Lübeck, Schleswig-Holstein, Germany

Local Institution - 0016

Jena, Thuringia, Germany

Local Institution - 0403

Berlin, , Germany

Local Institution - 0071

Freiburg im Breisgau, , Germany

Local Institution - 0032

Hamburg, , Germany

Local Institution - 0077

Heidelberg, , Germany

Local Institution - 0454

München, , Germany

Local Institution - 0046

Münster, , Germany

Local Institution - 0423

Balatonfüred, Veszprém megye, Hungary

Local Institution - 0048

Budapest, , Hungary

Local Institution - 0039

Budapest, , Hungary

Local Institution - 0035

Budapest, , Hungary

Local Institution - 0417

Szeged, , Hungary

Local Institution - 0482

Ahmedabad, Gujarat, India

Local Institution - 0480

Bengaluru, Karnataka, India

Local Institution - 0481

Kochi, Kerala, India

Local Institution - 0483

Chandigarh, , India

Local Institution - 0330

Gurgaon, , India

Local Institution - 0025

Jerusalem, Jerusalem, Israel

Local Institution - 0057

Jerusalem, Jerusalem, Israel

Local Institution - 0026

Ashkelon, Tel Aviv, Israel

Local Institution - 0037

Tel Aviv, Tel Aviv, Israel

Local Institution - 0419

Haifa, , Israel

Local Institution - 0427

Petah Tikva, , Israel

Local Institution - 0074

Ramat Gan, , Israel

Local Institution - 0054

Rehovot, , Israel

Local Institution - 0253

Safed, , Israel

Local Institution - 0373

Florence, Tuscany, Italy

Local Institution - 0171

Pisa, , Italy

Local Institution - 0028

Roma, , Italy

Local Institution - 0370

Uwajima, Ehime, Japan

Local Institution - 0208

Himeji-Shi, Hyōgo, Japan

Local Institution - 0457

Kanazawa, Ishikawa-ken, Japan

Local Institution - 0107

Yokohama, Kanagawa, Japan

Local Institution - 0119

Nankoku-shi, Kochi, Japan

Local Institution - 0453

Tsu, Mie-ken, Japan

Local Institution - 0456

Sendai, Miyagi, Japan

Local Institution - 0452

Osaka, Osaka, Japan

Local Institution - 0315

Suita, Osaka, Japan

Local Institution - 0471

Takatsuki-Shi, Osaka, Japan

Local Institution - 0168

Hamamatsu, Shizuoka, Japan

Local Institution - 0477

Bunkyo-ku, Tokyo, Japan

Local Institution - 0505

Chuo-Ku, Tokyo, Japan

Local Institution - 0224

Itabashi-Ku, Tokyo, Japan

Local Institution - 0466

Koto-Ku, Tokyo, Japan

Local Institution - 0314

Shinjuku-ku, Tokyo, Japan

Local Institution - 0475

Shinjuku-ku, Tokyo, Japan

Local Institution - 0521

Fukuoka, , Japan

Local Institution - 0442

Nijmegen, Gelderland, Netherlands

Local Institution - 0434

Maastricht, Limburg, Netherlands

Local Institution - 0197

Amsterdam-Zuidoost, North Holland, Netherlands

Local Institution - 0213

Rotterdam, South Holland, Netherlands

Local Institution - 0061

Utrecht, , Netherlands

Local Institution - 0443

Lørenskog, , Norway

Local Institution - 0441

Oslo, , Norway

Local Institution - 0473

Trondheim, , Norway

Local Institution - 0042

Krakow, Lesser Poland Voivodeship, Poland

Local Institution - 0038

Wroclaw, Lower Silesian Voivodeship, Poland

Local Institution - 0091

Wroclaw, Lower Silesian Voivodeship, Poland

Local Institution - 0338

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0203

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0072

Rzeszów, Podkarpackie Voivodeship, Poland

Local Institution - 0017

Katowice, Silesian Voivodeship, Poland

Local Institution - 0415

Zabrze, Silesian Voivodeship, Poland

Local Institution - 0030

Bialystok, , Poland

Local Institution - 0416

Lódz, , Poland

Local Institution - 0059

Lodz, Łódź Voivodeship, Poland

Local Institution - 0044

Guimarães, Braga District, Portugal

Local Institution - 0015

Almada, , Portugal

Local Institution - 0433

Leiria, , Portugal

Local Institution - 0023

Lisbon, , Portugal

Local Institution - 0024

Lisbon, , Portugal

Local Institution - 0014

Vila Nova de Gaia, , Portugal

Local Institution - 0516

Daegu, Daegu Gwang'yeogsi, South Korea

Local Institution - 0518

Incheon, Incheon Gwang'yeogsi, South Korea

Local Institution - 0012

Seoul, Seoul Teugbyeolsi, South Korea

Local Institution - 0055

Seoul, Seoul Teugbyeolsi, South Korea

Local Institution - 0460

Seoul, Seoul Teugbyeolsi, South Korea

Local Institution - 0517

Busan, , South Korea

Local Institution - 0508

Seongnam-si, , South Korea

Local Institution - 0217

Seoul, , South Korea

Local Institution - 0049

Seoul, , South Korea

Local Institution - 0040

Palma de Mallorca, Balearic Islands, Spain

Local Institution - 0299

L'Hospitalet de Llobregat, Barcelona, Spain

Local Institution - 0021

Majadahonda, Madrid, Spain

Local Institution - 0237

El Palmar, Murcia, Spain

Local Institution - 0043

A Coruña, , Spain

Local Institution - 0087

Alicante, , Spain

Local Institution - 0018

Barcelona, , Spain

Local Institution - 0056

Barcelona, , Spain

Local Institution - 0060

Granada, , Spain

Local Institution - 0421

Madrid, , Spain

Local Institution - 0041

Málaga, , Spain

Local Institution - 0031

Salamanca, , Spain

Local Institution - 0051

Seville, , Spain

Local Institution - 0027

Valencia, , Spain

Local Institution - 0445

London, Greater London, United Kingdom

Local Institution - 0073

Glasgow, Lanarkshire, United Kingdom

Local Institution - 0407

Birmingham, , United Kingdom

Local Institution - 0472

London, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Brazil; Canada; China; Czechia; Denmark; France; Germany; Hungary; India; Israel; Italy; Japan; Netherlands; Norway; Poland; Portugal; South Korea; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38625800 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40888717 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40864018 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39909647 (View on PubMed)

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

U1111-1269-8581

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-506352-24

Identifier Type: REGISTRY

Identifier Source: secondary_id

CV027-031

Identifier Type: -

Identifier Source: org_study_id