A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified October 2025 by Bristol-Myers Squibb
Sponsor
Bristol-Myers Squibb
Information Provided by (Responsible Party)
Bristol-Myers Squibb
Clinicaltrials.gov Identifier
NCT05582395
Other Study ID Numbers:
CV027-031
First Submitted
September 13, 2022
First Posted
October 16, 2022
Last Update Posted
November 13, 2025
Last Verified
October 2025

ClinicalTrials.gov processed this data on November 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Cardiomyopathy, Hypertrophic
Drug: MavacamtenOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment580 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Study Start DateDecember 13, 2022
Actual Primary Completion DateMarch 5, 2025
Actual Study Completion DateOctober 19, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Mavacamten
Drug: Mavacamten
Specified dose on specified days
Placebo
Other: Placebo
Specified dose on specified days

Outcome Measures

Primary Outcome Measures
  1. Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48
  2. Change from baseline in peak oxygen consumption (pVO2) at Week 48
Secondary Outcome Measures
  1. Change from baseline in ventilatory efficiency (VE/VCO2) slope to Week 48
  2. Proportion of participants with at least 1 class of New York Heart Association (NYHA) improvement from baseline to Week 48
  3. Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) to Week 48
  4. Change from baseline in hypertrophic cardiomyopathy symptom questionnaire-shortness of breath (HCMSQ-SoB) domain to Week 48

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion 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
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.

Contacts and Locations

Sponsors and CollaboratorsBristol-Myers Squibb
Locations
Local Institution - 0082 | Birmingham Alabama, United States, 35233-1900Local Institution - 0458 | Phoenix Arizona, United States, 85054Local Institution - 0409 | La Jolla California, United States, 92037-1337Local Institution - 0010 | Los Angeles California, United States, 90048-3311Local Institution - 0406 | San Francisco California, United States, 94143-2204Local Institution - 0079 | Stanford California, United States, 94305-2200Local Institution - 0468 | Gainesville Florida, United States, 32608-1134Local Institution - 0281 | Tampa Florida, United States, 33606-3603Local Institution - 0092 | Atlanta Georgia, United States, 30322Local Institution - 0424 | Indianapolis Indiana, United States, 46202-1243Local Institution - 0070 | Iowa City Iowa, United States, 52242-1009Local Institution - 0410 | Kansas City Kansas, United States, 66160-8500Local Institution - 0484 | Louisville Kentucky, United States, 40217-1363Local Institution - 0127 | Baltimore Maryland, United States, 21287Local Institution - 0479 | Boston Massachusetts, United States, 02114Local Institution - 0500 | Boston Massachusetts, United States, 02118-2908Local Institution - 0464 | Ann Arbor Michigan, United States, 48109Local Institution - 0064 | Detroit Michigan, United States, 48202-2608Local Institution - 0455 | Grand Rapids Michigan, United States, 49525Local Institution - 0431 | Rochester Minnesota, United States, 55905Local Institution - 0461 | St Louis Missouri, United States, 63110Local Institution - 0435 | Omaha Nebraska, United States, 68198-2265Local Institution - 0490 | Morristown New Jersey, United States, 07962Local Institution - 0449 | Manhasset New York, United States, 11030-3816Local Institution - 0486 | New York New York, United States, 10019-1147Local Institution - 0007 | Stony Brook New York, United States, 11790-3407Local Institution - 0426 | Valhalla New York, United States, 10595Local Institution - 0094 | Charlotte North Carolina, United States, 28204-2826Local Institution - 0065 | Durham North Carolina, United States, 27710Local Institution - 0083 | Cleveland Ohio, United States, 44195Local Institution - 0047 | Hershey Pennsylvania, United States, 17033Local Institution - 0444 | Lancaster Pennsylvania, United States, 17602-2250Local Institution - 0263 | Philadelphia Pennsylvania, United States, 19104Local Institution - 0081 | Pittsburgh Pennsylvania, United States, 15213-2536Local Institution - 0207 | Germantown Tennessee, United States, 38138-1727Local Institution - 0089 | Dallas Texas, United States, 75246Local Institution - 0365 | Dallas Texas, United States, 75390Local Institution - 0492 | Plano Texas, United States, 75093Local Institution - 0402 | Salt Lake City Utah, United States, 84132-0001Local Institution - 0478 | Charlottesville Virginia, United States, 22908-0001Local Institution - 0095 | Richmond Virginia, United States, 23298-5024Local Institution - 0063 | Concord New South Wales, Australia, 2139Local Institution - 0085 | Darlinghurst New South Wales, Australia, 2010Local Institution - 0369 | Sydney New South Wales, Australia, 2170Local Institution - 0080 | Chermside Queensland, Australia, 4032Local Institution - 0078 | Milton Queensland, Australia, 4064Local Institution - 0050 | Bedford Park South Australia, Australia, 5042Local Institution - 0076 | Murdoch Western Australia, Australia, 6150Local Institution - 0090 | Innsbruck Tyrol, Austria, 6020Local Institution - 0075 | Linz Upper Austria, Austria, 4020Local Institution - 0069 | Braunau am Inn Upper Austria (Oberösterreich), Austria, 5280Local Institution - 0062 | Graz , Austria, 8036Local Institution - 0429 | Vienna , Austria, 1090Local Institution - 0462 | Edegem Antwerpen, Belgium, 2650Local Institution - 0034 | Anderlecht Brussels Capital, Belgium, 1070Local Institution - 0476 | Genk Limburg, Belgium, 3600Local Institution - 0319 | Leuven Vlaams Brabant, Belgium, 3000Local Institution - 0413 | Salvador Estado de Bahia, Brazil, 40170-130Local Institution - 0438 | Brasília Federal District, Brazil, 70710-140Local Institution - 0488 | Belo Horizonte Minas Gerais, Brazil, 30220-140Local Institution - 0447 | Porto Alegre Rio Grande do Sul, Brazil, 90560-030Local Institution - 0450 | Porto Alegre Rio Grande do Sul, Brazil, 90620-001Local Institution - 0430 | Bragança Paulista São Paulo, Brazil, 12916-542Local Institution - 0422 | Ribeirão Preto São Paulo, Brazil, 14026-900Local Institution - 0412 | São Paulo São Paulo, Brazil, 05403-000Local Institution - 0446 | Rio de Janeiro , Brazil, 20551-030Local Institution - 0451 | Rio de Janeiro , Brazil, 22061-080Local Institution - 0418 | São Paulo , Brazil, 04012-180Local Institution - 0381 | Calgary Alberta, Canada, T2N 1N4Local Institution - 0467 | Vancouver British Columbia, Canada, V6E 1M7Local Institution - 0414 | Hamilton Ontario, Canada, L8L 2X2Local Institution - 0411 | London Ontario, Canada, N6A 5A5Local Institution - 0093 | Québec Quebec, Canada, G1V 4G5Local Institution - 0535 | Beijing Beijing Municipality, China, 100083Local Institution - 0534 | Beijing Beijing Municipality, China, 100730Local Institution - 0503 | Chongqing Chongqing Municipality, China, 400016Local Institution - 0541 | Chongqing Chongqing Municipality, China, 400016Local Institution - 0539 | Guangzhou Guangdong, China, 510120Local Institution - 0543 | Guangzhou Guangdong, China, 510515Local Institution - 0549 | Zhengzhou Henan, China, 450003Local Institution - 0542 | Wuhan Hubei, China, 430060Local Institution - 0548 | Changsha Hunan, China, 410011Local Institution - 0545 | Suzhou Jiangsu, China, 215006Local Institution - 0550 | Nanchang Jiangxi, China, 330008Local Institution - 0544 | Changchun Jilin, China, 130041Local Institution - 0540 | Dalian Liaoning, China, 116011Local Institution - 0501 | Shenyang Liaoning, China, 110016Local Institution - 0538 | Shenyang Liaoning, China, 110016Local Institution - 0547 | Xi'an Shan1xi, China, 710061Local Institution - 0546 | Jinan Shandong, China, 250021Local Institution - 0537 | Shanghai Shanghai Municipality, China, 200127Local Institution - 0533 | Chengdu Sichuan, China, 610000Local Institution - 0552 | Chengdu Sichuan, China, 610015Local Institution - 0536 | Wenzhou Zhejiang, China, 325000Local Institution - 0502 | Beijing , China, 100730Local Institution - 0553 | Beijing , China, 102218Local Institution - 0086 | Broumov Hradec Králové Region, Czechia, 550 01Local Institution - 0052 | Prague Praha, Hlavní Mesto, Czechia, 128 21Local Institution - 0033 | Prague Praha, Hlavní Mesto, Czechia, 140 21Local Institution - 0188 | Brno , Czechia, 656 91Local Institution - 0045 | Aalborg North Denmark, Denmark, DK-9000Local Institution - 0428 | Aabenraa Sønderjylland, Denmark, 6200Local Institution - 0019 | Aarhus N , Denmark, 8200Local Institution - 0001 | Nice Alpes-Maritimes, France, 06000Local Institution - 0463 | Brest Finistère, France, 29200Local Institution - 0005 | Toulouse Haute-Garonne, France, 31400Local Institution - 0003 | Chambray-lès-Tours Indre-et-Loire, France, 37044Local Institution - 0489 | La Tronche Isère, France, 38700Local Institution - 0067 | Bron Rhône, France, 69500Local Institution - 0009 | Nantes , France, 44093Local Institution - 0004 | Paris , France, 75013Local Institution - 0006 | Paris , France, 75015Local Institution - 0053 | Pessac , France, 33604Local Institution - 0008 | Rennes , France, 35000Local Institution - 0404 | Ulm Baden-Wurttemberg, Germany, 89081Local Institution - 0022 | München Bavaria, Germany, 81377Local Institution - 0440 | Regensburg Bavaria, Germany, 93053Local Institution - 0013 | Bad Nauheim Hesse, Germany, 61231Local Institution - 0496 | Göttingen Lower Saxony, Germany, 37075Local Institution - 0448 | Hanover Lower Saxony, Germany, 30625Local Institution - 0273 | Cologne North Rhine Wesrphalia, Germany, 50924Local Institution - 0439 | Bad Oeynhausen North Rhine-Westphalia, Germany, 32545Local Institution - 0174 | Bielefeld North Rhine-Westphalia, Germany, 33604Local Institution - 0420 | Mainz Rhineland-Palatinate, Germany, 55131Local Institution - 0066 | Lübeck Schleswig-Holstein, Germany, 23538Local Institution - 0016 | Jena Thuringia, Germany, 07747Local Institution - 0403 | Berlin , Germany, 13353Local Institution - 0071 | Freiburg im Breisgau , Germany, 79106Local Institution - 0032 | Hamburg , Germany, 20246Local Institution - 0077 | Heidelberg , Germany, 69120Local Institution - 0454 | München , Germany, 80636Local Institution - 0046 | Münster , Germany, 48149Local Institution - 0423 | Balatonfüred Veszprém megye, Hungary, 8230Local Institution - 0048 | Budapest , Hungary, 1096Local Institution - 0039 | Budapest , Hungary, 1097Local Institution - 0035 | Budapest , Hungary, 1122Local Institution - 0417 | Szeged , Hungary, 6720Local Institution - 0482 | Ahmedabad Gujarat, India, 380060Local Institution - 0480 | Bengaluru Karnataka, India, 560099Local Institution - 0481 | Kochi Kerala, India, 682001Local Institution - 0483 | Chandigarh , India, 160012Local Institution - 0330 | Gurgaon , India, 122 001Local Institution - 0025 | Jerusalem Jerusalem, Israel, 90000Local Institution - 0057 | Jerusalem Jerusalem, Israel, 9103102Local Institution - 0026 | Ashkelon Tel Aviv, Israel, 7830604Local Institution - 0037 | Tel Aviv Tel Aviv, Israel, 6423906Local Institution - 0419 | Haifa , Israel, 3109601Local Institution - 0427 | Petah Tikva , Israel, 49100Local Institution - 0074 | Ramat Gan , Israel, 5265601Local Institution - 0054 | Rehovot , Israel, 76100Local Institution - 0253 | Safed , Israel, 13100Local Institution - 0373 | Florence Tuscany, Italy, 50139Local Institution - 0171 | Pisa , Italy, 56124Local Institution - 0028 | Roma , Italy, 00189Local Institution - 0370 | Uwajima Ehime, Japan, 798-8510Local Institution - 0208 | Himeji-Shi Hyōgo, Japan, 672-8044Local Institution - 0457 | Kanazawa Ishikawa-ken, Japan, 920-8641Local Institution - 0107 | Yokohama Kanagawa, Japan, 227-8501Local Institution - 0119 | Nankoku-shi Kochi, Japan, 783-8505Local Institution - 0453 | Tsu Mie-ken, Japan, 514-8507Local Institution - 0456 | Sendai Miyagi, Japan, 980-8574Local Institution - 0452 | Osaka Osaka, Japan, 545-0051Local Institution - 0315 | Suita Osaka, Japan, 564-8565Local Institution - 0471 | Takatsuki-Shi Osaka, Japan, 569-8686Local Institution - 0168 | Hamamatsu Shizuoka, Japan, 431-3192Local Institution - 0477 | Bunkyo-ku Tokyo, Japan, 1138603Local Institution - 0505 | Chuo-Ku Tokyo, Japan, 104-0044Local Institution - 0224 | Itabashi-Ku Tokyo, Japan, 173-0003Local Institution - 0466 | Koto-Ku Tokyo, Japan, 135-0061Local Institution - 0314 | Shinjuku-ku Tokyo, Japan, 160-8582Local Institution - 0475 | Shinjuku-ku Tokyo, Japan, 162-8666Local Institution - 0521 | Fukuoka , Japan, 810-0001Local Institution - 0442 | Nijmegen Gelderland, Netherlands, 6525 GALocal Institution - 0434 | Maastricht Limburg, Netherlands, 6229 HXLocal Institution - 0197 | Amsterdam-Zuidoost North Holland, Netherlands, 1105 AZLocal Institution - 0213 | Rotterdam South Holland, Netherlands, 3015 GDLocal Institution - 0061 | Utrecht , Netherlands, 3584 CXLocal Institution - 0443 | Lørenskog , Norway, 1478Local Institution - 0441 | Oslo , Norway, 0424Local Institution - 0473 | Trondheim , Norway, 7030Local Institution - 0042 | Krakow Lesser Poland Voivodeship, Poland, 31-202Local Institution - 0038 | Wroclaw Lower Silesian Voivodeship, Poland, 50-556Local Institution - 0091 | Wroclaw Lower Silesian Voivodeship, Poland, 50-981Local Institution - 0338 | Warsaw Masovian Voivodeship, Poland, 02-097Local Institution - 0203 | Warsaw Masovian Voivodeship, Poland, 02-507Local Institution - 0072 | Rzeszów Podkarpackie Voivodeship, Poland, 35-055Local Institution - 0017 | Katowice Silesian Voivodeship, Poland, 40-555Local Institution - 0415 | Zabrze Silesian Voivodeship, Poland, 41-800Local Institution - 0030 | Bialystok , Poland, 15-276Local Institution - 0416 | Lódz , Poland, 93-338Local Institution - 0059 | Lodz Łódź Voivodeship, Poland, 91-347Local Institution - 0044 | Guimarães Braga District, Portugal, 4835-044Local Institution - 0015 | Almada , Portugal, 2805-267Local Institution - 0433 | Leiria , Portugal, 2410-197Local Institution - 0023 | Lisbon , Portugal, 1500-650Local Institution - 0024 | Lisbon , Portugal, 1649-035Local Institution - 0014 | Vila Nova de Gaia , Portugal, 4434-502Local Institution - 0516 | Daegu Daegu Gwang'yeogsi, South Korea, 42601Local Institution - 0518 | Incheon Incheon Gwang'yeogsi, South Korea, 22332Local Institution - 0012 | Seoul Seoul Teugbyeolsi, South Korea, 03722Local Institution - 0055 | Seoul Seoul Teugbyeolsi, South Korea, 6351Local Institution - 0460 | Seoul Seoul Teugbyeolsi, South Korea, 6591Local Institution - 0517 | Busan , South Korea, 49241Local Institution - 0508 | Seongnam-si , South Korea, 0Local Institution - 0217 | Seoul , South Korea, 03080Local Institution - 0049 | Seoul , South Korea, 05505Local Institution - 0040 | Palma de Mallorca Balearic Islands, Spain, 07198Local Institution - 0299 | L'Hospitalet de Llobregat Barcelona, Spain, 08907Local Institution - 0021 | Majadahonda Madrid, Spain, 28222Local Institution - 0237 | El Palmar Murcia, Spain, 30120Local Institution - 0043 | A Coruña , Spain, 15006Local Institution - 0087 | Alicante , Spain, 03010Local Institution - 0018 | Barcelona , Spain, 08035Local Institution - 0056 | Barcelona , Spain, 08036Local Institution - 0060 | Granada , Spain, 18014Local Institution - 0421 | Madrid , Spain, 28034Local Institution - 0041 | Málaga , Spain, 29010Local Institution - 0031 | Salamanca , Spain, 37007Local Institution - 0051 | Seville , Spain, 41009Local Institution - 0027 | Valencia , Spain, 46026Local Institution - 0445 | London Greater London, United Kingdom, SW3 6NPLocal Institution - 0073 | Glasgow Lanarkshire, United Kingdom, G51 4TFLocal Institution - 0407 | Birmingham , United Kingdom, B15 2THLocal Institution - 0472 | London , United Kingdom, EC1A 7BE
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb