A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

Phase 3

Active, not recruiting

• Conditions: Cardiomyopathy, Hypertrophic
• Interventions: Drug: Mavacamten; Other: Placebo

• Registration Number: NCT05582395
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-17
• Study Start: 2022-12-14
• Primary Completion: 2025-03-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Study Completion: 2029-06-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mavacamten	Mavacamten	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in peak oxygen consumption (pVO2) at Week 48	Up to Week 48
Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48	Up to Week 48

Secondary Outcome Measures

Name	Time	Method
Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) to Week 48	Up to Week 48
Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48	Up to Week 48
Change from baseline in ventilatory efficiency (VE/VCO2) slope to Week 48	Up to Week 48
Proportion of participants with at least 1 class of New York Heart Association (NYHA) improvement from baseline to Week 48	Up to Week 48

Trial Locations

Locations (224)

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; 🇺🇸 Saint 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 - 0075; 🇦🇹 Linz, Oberösterreich, Austria

Local Institution - 0090; 🇦🇹 Innsbruck, Tirol, Austria

Local Institution - 0069; 🇦🇹 Braunau am Inn, Upper Austria (Oberösterreich), Austria

Local Institution - 0062; 🇦🇹 Graz, Austria

Local Institution - 0429; 🇦🇹 Wien, Austria

Local Institution - 0462; 🇧🇪 Edegem, Antwerpen, Belgium

Local Institution - 0034; 🇧🇪 Anderlecht, Brussels, Belgium

Local Institution - 0476; 🇧🇪 Genk, Limburg, Belgium

Local Institution - 0319; 🇧🇪 Leuven, Vlaams Brabant, Belgium

Local Institution - 0413; 🇧🇷 Salvador, Bahia, Brazil

Local Institution - 0438; 🇧🇷 Brasília, Distrito Federal, Brazil

Local Institution - 0488; 🇧🇷 Belo Horizonte, MG, 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, SAO Paulo, Brazil

Local Institution - 0422; 🇧🇷 Ribeirão Preto, SAO Paulo, Brazil

Local Institution - 0412; 🇧🇷 São Paulo, SAO Paulo, Brazil

Local Institution - 0446; 🇧🇷 Rio De Janeiro, Brazil

Local Institution - 0451; 🇧🇷 Rio de Janeiro, Brazil

Local Institution - 0418; 🇧🇷 Sao 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; 🇨🇦 Quebec, Canada

Local Institution - 0535; 🇨🇳 Beijing, Beijing, China

Local Institution - 0534; 🇨🇳 Beijing, Beijing, China

Local Institution - 0503; 🇨🇳 Chongqing, Chongqing, China

Local Institution - 0541; 🇨🇳 Chongqing, Chongqing, 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; 🇨🇳 Xian, Shan1xi, China

Local Institution - 0546; 🇨🇳 Jinan, Shandong, China

Local Institution - 0537; 🇨🇳 Shanghai, Shanghai, 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 - 0033; 🇨🇿 Prague, Praha, Hlavní Mesto, Czechia

Local Institution - 0052; 🇨🇿 Praha 2, Praha, Hlavní Mesto, Czechia

Local Institution - 0188; 🇨🇿 Brno, Czechia

Local Institution - 0045; 🇩🇰 Ålborg, Nordjylland, 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 Cedex 01, 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-Württemberg, Germany

Local Institution - 0022; 🇩🇪 München, Bayern, Germany

Local Institution - 0440; 🇩🇪 Regensburg, Bayern, Germany

Local Institution - 0013; 🇩🇪 Bad Nauheim, Hessen, Germany

Local Institution - 0496; 🇩🇪 Göttingen, Niedersachsen, Germany

Local Institution - 0448; 🇩🇪 Hannover, Niedersachsen, Germany

Local Institution - 0439; 🇩🇪 Bad Oeynhausen, Nordrhein-Westfalen, Germany

Local Institution - 0174; 🇩🇪 Bielefeld, Nordrhein-Westfalen, Germany

Local Institution - 0273; 🇩🇪 Köln, North Rhine Wesrphalia, Germany

Local Institution - 0420; 🇩🇪 Mainz, Rheinland-Pfalz, Germany

Local Institution - 0066; 🇩🇪 Luebeck, Schleswig-Holstein, Germany

Local Institution - 0016; 🇩🇪 Jena, Thüringen, Germany

Local Institution - 0403; 🇩🇪 Berlin, Germany

Local Institution - 0071; 🇩🇪 Freiburg, 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, 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 - 0026; 🇮🇱 Ashkelon, Tel-Aviv, Israel

Local Institution - 0037; 🇮🇱 Tel Aviv, Tel-Aviv, Israel

Local Institution - 0025; 🇮🇱 Jerusalem, Yerushalayim, Israel

Local Institution - 0057; 🇮🇱 Jerusalem, Yerushalayim, 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; 🇮🇹 Firenze, Toscana, Italy

Local Institution - 0171; 🇮🇹 Pisa, Italy

Local Institution - 0028; 🇮🇹 Roma, Italy

Local Institution - 0370; 🇯🇵 Uwajima, Ehime, Japan

Local Institution - 0208; 🇯🇵 Himeji-Shi, Hyogo, Japan

Local Institution - 0457; 🇯🇵 Kanazawa-shi, Ishikawa, Japan

Local Institution - 0107; 🇯🇵 Yokohama, Kanagawa, Japan

Local Institution - 0119; 🇯🇵 Nankoku-shi, Kochi, Japan

Local Institution - 0453; 🇯🇵 Tsu, MIE, Japan

Local Institution - 0456; 🇯🇵 Sendai, Miyagi, Japan

Local Institution - 0452; 🇯🇵 Osaka-Shi, Osaka, Japan

Local Institution - 0315; 🇯🇵 Suita, Osaka, Japan

Local Institution - 0471; 🇯🇵 Takatsuki-Shi, Osaka, Japan

Local Institution - 0168; 🇯🇵 Hamamatsu-city, 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 - 0516; 🇰🇷 Daegu, Daegu Gwang'yeogsi, Korea, Republic of

Local Institution - 0518; 🇰🇷 Incheon, Incheon Gwang'yeogsi, Korea, Republic of

Local Institution - 0012; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Local Institution - 0055; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Local Institution - 0460; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Local Institution - 0517; 🇰🇷 Busan, Korea, Republic of

Local Institution - 0508; 🇰🇷 Seongnam-si, Korea, Republic of

Local Institution - 0217; 🇰🇷 Seoul, Korea, Republic of

Local Institution - 0049; 🇰🇷 Seoul, Korea, Republic of

Local Institution - 0442; 🇳🇱 Nijmegen, Gelderland, Netherlands

Local Institution - 0434; 🇳🇱 Maastricht, Limburg, Netherlands

Local Institution - 0197; 🇳🇱 Amsterdam Zuidoost, Noord-Holland, Netherlands

Local Institution - 0213; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Local Institution - 0061; 🇳🇱 Utrecht, Netherlands

Local Institution - 0443; 🇳🇴 Lørenskog, Norway

Local Institution - 0441; 🇳🇴 Oslo, Norway

Local Institution - 0473; 🇳🇴 Trondheim, Norway

Local Institution - 0038; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Local Institution - 0091; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Local Institution - 0059; 🇵🇱 Lodz, Lodzkie, Poland

Local Institution - 0042; 🇵🇱 Kraków, Malopolskie, Poland

Local Institution - 0338; 🇵🇱 Warszawa, Mazowieckie, Poland

Local Institution - 0203; 🇵🇱 Warszawa, Mazowieckie, Poland

Local Institution - 0072; 🇵🇱 Rzeszów, Podkarpackie, Poland

Local Institution - 0017; 🇵🇱 Katowice, Slaskie, Poland

Local Institution - 0415; 🇵🇱 Zabrze, Slaskie, Poland

Local Institution - 0030; 🇵🇱 Bialystok, Poland

Local Institution - 0416; 🇵🇱 Lódz, Poland

Local Institution - 0044; 🇵🇹 Guimarães, Braga, Portugal

Local Institution - 0015; 🇵🇹 Almada, Portugal

Local Institution - 0433; 🇵🇹 Leiria, Portugal

Local Institution - 0023; 🇵🇹 Lisboa, Portugal

Local Institution - 0024; 🇵🇹 Lisboa, Portugal

Local Institution - 0014; 🇵🇹 Vila Nova de Gaia, Portugal

Local Institution - 0040; 🇪🇸 Palma de Mallorca, Baleares, Spain

Local Institution - 0299; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Local Institution - 0021; 🇪🇸 Majadahonda, Madrid, Spain

Local Institution - 0237; 🇪🇸 El Palmar, Murcia, Spain

Local Institution - 0043; 🇪🇸 A Coruna, 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; 🇪🇸 Malaga, Spain

Local Institution - 0031; 🇪🇸 Salamanca, Spain

Local Institution - 0051; 🇪🇸 Sevilla, 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