Hypertrophic Cardiomyopathy Clinical Trial

A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

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).

View Eligibility Criteria

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.
Other protocol-defined Inclusion/Exclusion criteria apply.

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

420

Study ID:

NCT05582395

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 214 Locations for this study

See Locations Near You

Local Institution - 0082
Birmingham Alabama, 35233, United States
Local Institution - 0458
Phoenix Arizona, 85054, United States
Local Institution - 0409
La Jolla California, 92037, United States
Local Institution - 0010
Los Angeles California, 90048, United States
Local Institution - 0079
Palo Alto California, 94304, United States
Local Institution - 0406
San Francisco California, 94143, United States
Local Institution - 0468
Gainesville Florida, 32608, United States
Local Institution - 0281
Tampa Florida, 33606, United States
Local Institution - 0092
Atlanta Georgia, 30322, United States
Local Institution - 0424
Indianapolis Indiana, 46202, United States
Local Institution - 0070
Iowa City Iowa, 52242, United States
Local Institution - 0410
Kansas City Kansas, 66160, United States
Local Institution - 0484
Louisville Kentucky, 40217, United States
Local Institution - 0127
Baltimore Maryland, 21287, United States
Local Institution - 0479
Boston Massachusetts, 02114, United States
Local Institution - 0500
Boston Massachusetts, 02118, United States
Local Institution - 0464
Ann Arbor Michigan, 48109, United States
Local Institution - 0064
Detroit Michigan, 48202, United States
Local Institution - 0455
Grand Rapids Michigan, 49525, United States
Local Institution - 0431
Rochester Minnesota, 55905, United States
Local Institution - 0461
Saint Louis Missouri, 63110, United States
Local Institution - 0435
Omaha Nebraska, 68198, United States
Local Institution - 0490
Morristown New Jersey, 07962, United States
Local Institution - 0449
Manhasset New York, 11030, United States
Local Institution - 0486
New York New York, 10019, United States
Local Institution - 0007
Stony Brook New York, 11790, United States
Local Institution - 0426
Valhalla New York, 10595, United States
Local Institution - 0094
Charlotte North Carolina, 28402, United States
Local Institution - 0065
Durham North Carolina, 27710, United States
Local Institution - 0083
Cleveland Ohio, 44195, United States
Local Institution - 0047
Hershey Pennsylvania, 17033, United States
Local Institution - 0444
Lancaster Pennsylvania, 17602, United States
Local Institution - 0263
Philadelphia Pennsylvania, 19104, United States
Local Institution - 0081
Pittsburgh Pennsylvania, 15213, United States
Local Institution - 0207
Germantown Tennessee, 38138, United States
Local Institution - 0089
Dallas Texas, 75246, United States
Local Institution - 0365
Dallas Texas, 75390, United States
Local Institution - 0492
Plano Texas, 75093, United States
Local Institution - 0402
Salt Lake City Utah, 84132, United States
Local Institution - 0478
Charlottesville Virginia, 22908, United States
Local Institution - 0095
Richmond Virginia, 23298, United States
Local Institution - 0063
Concord New South Wales, 2139, Australia
Local Institution - 0085
Darlinghurst New South Wales, 2010, Australia
Local Institution - 0369
Sydney New South Wales, 2170, Australia
Local Institution - 0080
Chermside Queensland, 4032, Australia
Local Institution - 0078
Milton Queensland, 4064, Australia
Local Institution - 0050
Bedford Park South Australia, 5042, Australia
Local Institution - 0076
Murdoch Western Australia, 6150, Australia
Local Institution - 0075
Linz Oberösterreich, 4020, Austria
Local Institution - 0090
Innsbruck Tirol, 6020, Austria
Local Institution - 0069
Braunau am Inn Upper Austria, 5280, Austria
Local Institution - 0062
Graz , 8036, Austria
Local Institution - 0429
Wien , 1090, Austria
Local Institution - 0462
Edegem Antwerpen, 2650, Belgium
Local Institution - 0034
Anderlecht Brussels, 1070, Belgium
Local Institution - 0476
Genk Limburg, 3600, Belgium
Local Institution - 0319
Leuven Vlaams Brabant, 3000, Belgium
Local Institution - 0413
Salvador Bahia, 40170, Brazil
Local Institution - 0438
Brasília Distrito Federal, 70710, Brazil
Local Institution - 0488
Belo Horizonte MG, 30220, Brazil
Local Institution - 0447
Porto Alegre RIO Grande DO SUL, 90560, Brazil
Local Institution - 0450
Porto Alegre RIO Grande DO SUL, 90620, Brazil
Local Institution - 0430
Bragança Paulista SAO Paulo, 12916, Brazil
Local Institution - 0422
Ribeirão Preto SAO Paulo, 14026, Brazil
Local Institution - 0412
São Paulo SAO Paulo, 05403, Brazil
Local Institution - 0446
Rio De Janeiro , 20551, Brazil
Local Institution - 0451
Rio de Janeiro , 22061, Brazil
Local Institution - 0418
Sao Paulo , 04012, Brazil
Local Institution - 0381
Calgary Alberta, T2N 1, Canada
Local Institution - 0467
Vancouver British Columbia, V6E 1, Canada
Local Institution - 0414
Hamilton Ontario, L8L 2, Canada
Local Institution - 0411
London Ontario, N6A 5, Canada
Local Institution - 0093
Quebec , G1V 4, Canada
Local Institution - 0535
Beijing Beijing, 10008, China
Local Institution - 0534
Beijing Beijing, 10073, China
Local Institution - 0503
Chongqing Chongqing, 40001, China
Local Institution - 0541
Chongqing Chongqing, 40001, China
Local Institution - 0539
Guangzhou Guangdong, 51012, China
Local Institution - 0543
Guangzhou Guangdong, 51051, China
Local Institution - 0542
Wuhan Hubei, 43006, China
Local Institution - 0545
Suzhou Jiangsu, 21500, China
Local Institution - 0544
Changchun Jilin, 13004, China
Local Institution - 0540
Dalian Liaoning, 11601, China
Local Institution - 0501
Shenyang Liaoning, 11001, China
Local Institution - 0538
Shenyang Liaoning, 11001, China
Local Institution - 0546
Jinan Shandong, 25002, China
Local Institution - 0537
Shanghai Shanghai, 20012, China
Local Institution - 0533
Chengdu Sichuan, 61000, China
Local Institution - 0536
Wenzhou Zhejiang, 32500, China
Local Institution - 0502
Beijing , 10073, China
Local Institution - 0086
Broumov Královéhradecký Kraj, 550 0, Czechia
Local Institution - 0033
Prague Praha, Hlavní Mesto, 140 2, Czechia
Local Institution - 0052
Praha 2 Praha, Hlavní Mesto, 128 2, Czechia
Local Institution - 0188
Brno , 656 9, Czechia
Local Institution - 0045
Aalborg Nordjylland, 9000, Denmark
Local Institution - 0428
Aabenraa South Denmark, 6200, Denmark
Local Institution - 0019
Aarhus N , 8200, Denmark
Local Institution - 0001
Nice Alpes-Maritimes, 06000, France
Local Institution - 0463
Brest Finistère, 29200, France
Local Institution - 0005
Toulouse Haute-Garonne, 31000, France
Local Institution - 0003
Chambray-lès-tours Indre-et-Loire, 37044, France
Local Institution - 0489
La Tronche Isère, 38700, France
Local Institution - 0067
Bron Rhône, 69500, France
Local Institution - 0009
Nantes Cedex 01 , 44093, France
Local Institution - 0004
Paris , 75013, France
Local Institution - 0006
Paris , 75015, France
Local Institution - 0053
Pessac , 33604, France
Local Institution - 0008
Rennes , 35000, France
Local Institution - 0404
Ulm Baden-Württemberg, 89081, Germany
Local Institution - 0022
München Bayern, 81377, Germany
Local Institution - 0440
Regensburg Bayern, 93053, Germany
Local Institution - 0013
Bad Nauheim Hessen, 61231, Germany
Local Institution - 0496
Göttingen Niedersachsen, 37075, Germany
Local Institution - 0448
Hannover Niedersachsen, 30625, Germany
Local Institution - 0439
Bad Oeynhausen Nordrhein-Westfalen, 32545, Germany
Local Institution - 0174
Bielefeld Nordrhein-Westfalen, 33604, Germany
Local Institution - 0420
Mainz Rheinland-Pfalz, 55131, Germany
Local Institution - 0066
Luebeck Schleswig-Holstein, 23538, Germany
Local Institution - 0016
Jena Thüringen, 07747, Germany
Local Institution - 0403
Berlin , 13353, Germany
Local Institution - 0071
Freiburg , 79106, Germany
Local Institution - 0032
Hamburg , 20246, Germany
Local Institution - 0077
Heidelberg , 69120, Germany
Local Institution - 0273
Köln , 50937, Germany
Local Institution - 0454
München , 80636, Germany
Local Institution - 0046
Münster , 48149, Germany
Local Institution - 0423
Balatonfüred Veszprém, 8230, Hungary
Local Institution - 0035
Budapest , 1083, Hungary
Local Institution - 0048
Budapest , 1096, Hungary
Local Institution - 0039
Budapest , 1097, Hungary
Local Institution - 0417
Szeged , 6720, Hungary
Local Institution - 0482
Ahmedabad Gujarat, 38006, India
Local Institution - 0480
Bengaluru Karnataka, 56009, India
Local Institution - 0481
Kochi Kerala, 68200, India
Local Institution - 0483
Chandigarh , 16001, India
Local Institution - 0330
Gurgaon , 122 0, India
Local Institution - 0026
Ashkelon Tel-Aviv, 78306, Israel
Local Institution - 0037
Tel Aviv Tel-Aviv, 64239, Israel
Local Institution - 0025
Jerusalem Yerushalayim, 90000, Israel
Local Institution - 0057
Jerusalem Yerushalayim, 91031, Israel
Local Institution - 0419
Haifa , 31096, Israel
Local Institution - 0427
Petah Tikva , 49100, Israel
Local Institution - 0074
Ramat Gan , 52621, Israel
Local Institution - 0054
Rehovot , 76100, Israel
Local Institution - 0253
Safed , 13100, Israel
Local Institution - 0028
Roma Lazio, 00189, Italy
Local Institution - 0373
Firenze Toscana, 50139, Italy
Local Institution - 0171
Massa Toscana, 54100, Italy
Local Institution - 0370
Uwajima Ehime, 798-8, Japan
Local Institution - 0208
Himeji-Shi Hyogo, 672-8, Japan
Local Institution - 0457
Kanazawa-shi Ishikawa, 920-8, Japan
Local Institution - 0107
Yokohama Kanagawa, 227-8, Japan
Local Institution - 0119
Nankoku-shi Kochi, 783-8, Japan
Local Institution - 0453
Tsu MIE, 514-8, Japan
Local Institution - 0456
Sendai Miyagi, 980-8, Japan
Local Institution - 0452
Osaka-Shi Osaka, 545-0, Japan
Local Institution - 0315
Suita Osaka, 564-8, Japan
Local Institution - 0471
Takatsuki-Shi Osaka, 569-8, Japan
Local Institution - 0168
Hamamatsu-city Shizuoka, 431-3, Japan
Local Institution - 0477
Bunkyo-ku Tokyo, 11386, Japan
Local Institution - 0505
Chuo-Ku Tokyo, 104-0, Japan
Local Institution - 0224
Itabashi-Ku Tokyo, 173-0, Japan
Local Institution - 0466
Koto-Ku Tokyo, 135-0, Japan
Local Institution - 0314
Shinjuku-ku Tokyo, 160-8, Japan
Local Institution - 0475
Shinjuku Tokyo, 16286, Japan
Local Institution - 0521
Fukuoka , 810-0, Japan
Local Institution - 0518
Incheon Incheon Gwang'yeogsi, 22332, Korea, Republic of
Local Institution - 0012
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Local Institution - 0055
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Local Institution - 0517
Busan , 49241, Korea, Republic of
Local Institution - 0516
Daegu , 42601, Korea, Republic of
Local Institution - 0508
Seongnam-si , 0, Korea, Republic of
Local Institution - 0217
Seoul , 03080, Korea, Republic of
Local Institution - 0049
Seoul , 05505, Korea, Republic of
Local Institution - 0460
Seoul , 06591, Korea, Republic of
Local Institution - 0442
Nijmegen Gelderland, 6525 , Netherlands
Local Institution - 0434
Maastricht Limburg, 6229 , Netherlands
Local Institution - 0197
Amsterdam Zuidoost Noord-Holland, 1105 , Netherlands
Local Institution - 0213
Rotterdam Zuid-Holland, 3015 , Netherlands
Local Institution - 0061
Utrecht , 3584 , Netherlands
Local Institution - 0443
Lørenskog , 1478, Norway
Local Institution - 0441
Oslo , 0424, Norway
Local Institution - 0473
Trondheim , 7030, Norway
Local Institution - 0038
Wroclaw Dolnoslaskie, 50-55, Poland
Local Institution - 0091
Wroclaw Dolnoslaskie, 50-98, Poland
Local Institution - 0059
Lodz Lodzkie, 91-34, Poland
Local Institution - 0042
Krakow Malopolskie, 31-20, Poland
Local Institution - 0338
Warszawa Mazowieckie, 02-09, Poland
Local Institution - 0203
Warszawa Mazowieckie, 02-50, Poland
Local Institution - 0072
Rzeszów Podkarpackie, 35-05, Poland
Local Institution - 0017
Katowice Slaskie, 40-55, Poland
Local Institution - 0415
Zabrze Slaskie, 41-80, Poland
Local Institution - 0030
Bialystok , 15-27, Poland
Local Institution - 0416
Lódz , 93-33, Poland
Local Institution - 0044
Guimarães Braga, 4835-, Portugal
Local Institution - 0014
Vila Nova de Gaia Porto, 4434-, Portugal
Local Institution - 0015
Almada , 2805-, Portugal
Local Institution - 0433
Leiria , 2410-, Portugal
Local Institution - 0023
Lisboa , 1500-, Portugal
Local Institution - 0024
Lisboa , 1649-, Portugal
Local Institution - 0040
Palma de Mallorca Baleares, 07198, Spain
Local Institution - 0299
Hospitalet de Llobregat Barcelona, 08907, Spain
Local Institution - 0021
Majadahonda Madrid, 28222, Spain
Local Institution - 0237
El Palmar Murcia, 30120, Spain
Local Institution - 0041
Malaga Málaga, 29010, Spain
Local Institution - 0043
A Coruna , 15006, Spain
Local Institution - 0087
Alicante , 03010, Spain
Local Institution - 0018
Barcelona , 08035, Spain
Local Institution - 0056
Barcelona , 08036, Spain
Local Institution - 0060
Granada , 18014, Spain
Local Institution - 0421
Madrid , 28034, Spain
Local Institution - 0031
Salamanca , 37007, Spain
Local Institution - 0051
Sevilla , 41009, Spain
Local Institution - 0027
Valencia , 46026, Spain
Local Institution - 0445
London Greater London, SW3 6, United Kingdom
Local Institution - 0073
Glasgow Lanarkshire, G51 4, United Kingdom
Local Institution - 0407
Birmingham , B15 2, United Kingdom
Local Institution - 0472
London , EC1A , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

420

Study ID:

NCT05582395

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.