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).
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.
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There are 216 Locations for this study
Birmingham Alabama, 35233, United States
Phoenix Arizona, 85054, United States
La Jolla California, 92037, United States
Los Angeles California, 90048, United States
Palo Alto California, 94304, United States
San Francisco California, 94143, United States
Gainesville Florida, 32608, United States
Tampa Florida, 33606, United States
Atlanta Georgia, 30322, United States
Indianapolis Indiana, 46202, United States
Iowa City Iowa, 52242, United States
Kansas City Kansas, 66160, United States
Louisville Kentucky, 40217, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02118, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49525, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Morristown New Jersey, 07962, United States
Manhasset New York, 11030, United States
New York New York, 10019, United States
Stony Brook New York, 11790, United States
Valhalla New York, 10595, United States
Charlotte North Carolina, 28402, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Hershey Pennsylvania, 17033, United States
Lancaster Pennsylvania, 17602, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Germantown Tennessee, 38138, United States
Dallas Texas, 75246, United States
Dallas Texas, 75390, United States
Plano Texas, 75093, United States
Salt Lake City Utah, 84132, United States
Charlottesville Virginia, 22908, United States
Richmond Virginia, 23298, United States
Concord New South Wales, 2139, Australia
Darlinghurst New South Wales, 2010, Australia
Sydney New South Wales, 2170, Australia
Chermside Queensland, 4032, Australia
Milton Queensland, 4064, Australia
Bedford Park South Australia, 5042, Australia
Murdoch Western Australia, 6150, Australia
Linz Oberösterreich, 4020, Austria
Innsbruck Tirol, 6020, Austria
Braunau am Inn Upper Austria, 5280, Austria
Graz , 8036, Austria
Wien , 1090, Austria
Edegem Antwerpen, 2650, Belgium
Anderlecht Brussels, 1070, Belgium
Genk Limburg, 3600, Belgium
Leuven Vlaams Brabant, 3000, Belgium
Salvador Bahia, 40170, Brazil
Brasília Distrito Federal, 70710, Brazil
Belo Horizonte MG, 30220, Brazil
Porto Alegre RIO Grande DO SUL, 90560, Brazil
Porto Alegre RIO Grande DO SUL, 90620, Brazil
Bragança Paulista SAO Paulo, 12916, Brazil
Ribeirão Preto SAO Paulo, 14026, Brazil
São Paulo SAO Paulo, 05403, Brazil
Rio De Janeiro , 20551, Brazil
Rio de Janeiro , 22061, Brazil
Sao Paulo , 04012, Brazil
Calgary Alberta, T2N 1, Canada
Vancouver British Columbia, V6E 1, Canada
Hamilton Ontario, L8L 2, Canada
London Ontario, N6A 5, Canada
Quebec , G1V 4, Canada
Beijing Beijing, 10008, China
Beijing Beijing, 10073, China
Chongqing Chongqing, 40001, China
Chongqing Chongqing, 40001, China
Guangzhou Guangdong, 51012, China
Guangzhou Guangdong, 51051, China
Wuhan Hubei, 43006, China
Changsha Hunan, 41001, China
Suzhou Jiangsu, 21500, China
Changchun Jilin, 13004, China
Dalian Liaoning, 11601, China
Shenyang Liaoning, 11001, China
Shenyang Liaoning, 11001, China
Xian Shan1xi, 71006, China
Jinan Shandong, 25002, China
Shanghai Shanghai, 20012, China
Chengdu Sichuan, 61000, China
Wenzhou Zhejiang, 32500, China
Beijing , 10073, China
Broumov Královéhradecký Kraj, 550 0, Czechia
Prague Praha, Hlavní Mesto, 140 2, Czechia
Praha 2 Praha, Hlavní Mesto, 128 2, Czechia
Brno , 656 9, Czechia
Aalborg Nordjylland, 9000, Denmark
Aabenraa South Denmark, 6200, Denmark
Aarhus N , 8200, Denmark
Nice Alpes-Maritimes, 06000, France
Brest Finistère, 29200, France
Toulouse Haute-Garonne, 31400, France
Chambray-lès-tours Indre-et-Loire, 37044, France
La Tronche Isère, 38700, France
Bron Rhône, 69500, France
Nantes Cedex 01 , 44093, France
Paris , 75013, France
Paris , 75015, France
Pessac , 33604, France
Rennes , 35000, France
Ulm Baden-Württemberg, 89081, Germany
München Bayern, 81377, Germany
Regensburg Bayern, 93053, Germany
Bad Nauheim Hessen, 61231, Germany
Göttingen Niedersachsen, 37075, Germany
Hannover Niedersachsen, 30625, Germany
Bad Oeynhausen Nordrhein-Westfalen, 32545, Germany
Bielefeld Nordrhein-Westfalen, 33604, Germany
Mainz Rheinland-Pfalz, 55131, Germany
Luebeck Schleswig-Holstein, 23538, Germany
Jena Thüringen, 07747, Germany
Berlin , 13353, Germany
Freiburg , 79106, Germany
Hamburg , 20246, Germany
Heidelberg , 69120, Germany
Köln , 50937, Germany
München , 80636, Germany
Münster , 48149, Germany
Balatonfüred Veszprém, 8230, Hungary
Budapest , 1083, Hungary
Budapest , 1096, Hungary
Budapest , 1097, Hungary
Szeged , 6720, Hungary
Ahmedabad Gujarat, 38006, India
Bengaluru Karnataka, 56009, India
Kochi Kerala, 68200, India
Chandigarh , 16001, India
Gurgaon , 122 0, India
Ashkelon Tel-Aviv, 78306, Israel
Tel Aviv Tel-Aviv, 64239, Israel
Jerusalem Yerushalayim, 90000, Israel
Jerusalem Yerushalayim, 91031, Israel
Haifa , 31096, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Rehovot , 76100, Israel
Safed , 13100, Israel
Roma Lazio, 00189, Italy
Firenze Toscana, 50139, Italy
Massa Toscana, 54100, Italy
Uwajima Ehime, 798-8, Japan
Himeji-Shi Hyogo, 672-8, Japan
Kanazawa-shi Ishikawa, 920-8, Japan
Yokohama Kanagawa, 227-8, Japan
Nankoku-shi Kochi, 783-8, Japan
Tsu MIE, 514-8, Japan
Sendai Miyagi, 980-8, Japan
Osaka-Shi Osaka, 545-0, Japan
Suita Osaka, 564-8, Japan
Takatsuki-Shi Osaka, 569-8, Japan
Hamamatsu-city Shizuoka, 431-3, Japan
Bunkyo-ku Tokyo, 11386, Japan
Chuo-Ku Tokyo, 104-0, Japan
Itabashi-Ku Tokyo, 173-0, Japan
Koto-Ku Tokyo, 135-0, Japan
Shinjuku-ku Tokyo, 160-8, Japan
Shinjuku Tokyo, 16286, Japan
Fukuoka , 810-0, Japan
Incheon Incheon Gwang'yeogsi, 22332, Korea, Republic of
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Busan , 49241, Korea, Republic of
Daegu , 42601, Korea, Republic of
Seongnam-si , 0, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06591, Korea, Republic of
Nijmegen Gelderland, 6525 , Netherlands
Maastricht Limburg, 6229 , Netherlands
Amsterdam Zuidoost Noord-Holland, 1105 , Netherlands
Rotterdam Zuid-Holland, 3015 , Netherlands
Utrecht , 3584 , Netherlands
Lørenskog , 1478, Norway
Oslo , 0424, Norway
Trondheim , 7030, Norway
Wroclaw Dolnoslaskie, 50-55, Poland
Wroclaw Dolnoslaskie, 50-98, Poland
Lodz Lodzkie, 91-34, Poland
Kraków Malopolskie, 31-20, Poland
Warszawa Mazowieckie, 02-09, Poland
Warszawa Mazowieckie, 02-50, Poland
Rzeszów Podkarpackie, 35-05, Poland
Katowice Slaskie, 40-55, Poland
Zabrze Slaskie, 41-80, Poland
Bialystok , 15-27, Poland
Lódz , 93-33, Poland
Guimarães Braga, 4835-, Portugal
Vila Nova de Gaia Porto, 4434-, Portugal
Almada , 2805-, Portugal
Leiria , 2410-, Portugal
Lisboa , 1500-, Portugal
Lisboa , 1649-, Portugal
Palma de Mallorca Baleares, 07198, Spain
Hospitalet de Llobregat Barcelona, 08907, Spain
Majadahonda Madrid, 28222, Spain
El Palmar Murcia, 30120, Spain
Malaga Málaga, 29010, Spain
A Coruna , 15006, Spain
Alicante , 03010, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Granada , 18014, Spain
Madrid , 28034, Spain
Salamanca , 37007, Spain
Sevilla , 41009, Spain
Valencia , 46026, Spain
London Greater London, SW3 6, United Kingdom
Glasgow Lanarkshire, G51 4, United Kingdom
Birmingham , B15 2, United Kingdom
London , EC1A , United Kingdom
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