Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM
NCT ID: NCT06081894
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2023-08-30
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aficamten
Participants in this arm will receive a single daily oral dose of 5 mg, 10 mg, 15 mg, or 20 mg of aficamten with dose levels guided by echocardiography assessments, for up to 72 weeks.
Aficamten
Oral Tablet
Placebo
Participants in this arm will receive placebo, for up to 72 weeks.
Placebo
Oral Tablet
Interventions
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Aficamten
Oral Tablet
Placebo
Oral Tablet
Eligibility Criteria
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Inclusion Criteria
* Body mass index \< 40 kg/m2
* Diagnosed with nHCM and has a screening echocardiogram with the following:
* End-diastolic left ventricular (LV) wall thickness:
* ≥ 15 mm in one or more myocardial segments OR
* ≥ 13 mm in one or more wall segments and a known disease-causing gene mutation or positive family history of HCM AND
* Resting LVOT-G \< 30 mmHg AND Valsalva LVOT-G \< 50 mmHg AND
* LVEF ≥ 60%
* Participants with a history of intracavitary obstruction are eligible.
* NYHA class II or III
* Respiratory exchange ratio of ≥ 1.00 at screening by cardiopulmonary exercise testing (CPET) and predicted peak oxygen uptake (pVO2) ≤ 90% for age and sex
* KCCQ-CSS score of ≤ 85
* NT-proBNP of:
* NT-pro BNP ≥ 300 pg/mL or NT-proBNP ≥ 900 pg/mL if in atrial fibrillation or atrial flutter OR
* For Black participants, an NT-pro BNP ≥ 225 pg/mL or NT-proBNP ≥ 675 pg/mL if in atrial fibrillation or atrial flutter
Exclusion Criteria
* Moderate or severe valvular aortic stenosis or fixed subaortic obstruction
* Moderate or severe mitral regurgitation
* Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)
* Known current unrevascularized coronary artery stenosis of ≥ 70% or documented history of myocardial infarction.
* History of LV systolic dysfunction (LVEF \< 45%) or stress cardiomyopathy
* Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)
* Documented room air oxygen saturation reading \< 90% at screening or history of significant chronic obstructive pulmonary disease or severe/significant pulmonary hypertension
* History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 3 months prior to screening
* History of resistant hypertension (persistently elevated blood pressure despite maximal doses of 3 or more classes of medications for hypertension control)
* Screening diastolic blood pressure ≥ 100 mmHg
* Received prior treatment with aficamten
* Received treatment with mavacamten within 3 months prior to screening (must be discussed with the medical monitor prior to screening)
* Undergone septal reduction therapy \< 6 months prior to screening
* Is being considered for or is likely to be considered for heart transplant listing or left ventricular assist device placement during the study period
* Paroxysmal or permanent atrial fibrillation is excluded only if:
* rhythm restoring treatment (e.g., direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤ 3 months prior to screening
* rate control and anticoagulation have not been achieved for at least 3 months prior to screening.
18 Years
85 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Bayer
INDUSTRY
Cytokinetics
INDUSTRY
Responsible Party
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Principal Investigators
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Cytokinetics MD
Role: STUDY_DIRECTOR
Cytokinetics
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California, United States
Keck Medical Center of USC (Outpatient Clinic)
Los Angeles, California, United States
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles, California, United States
UCLA Medical Center Cardiovascular Clinic
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Holy Cross Medical Group - Cardiology Associates
Fort Lauderdale, Florida, United States
Investigational Drug Services, AdventHealth Orlando
Orlando, Florida, United States
Emory Clinic
Atlanta, Georgia, United States
Piedmont Heart Institute (CPET)
Fayetteville, Georgia, United States
The Queen's Medical Center-Punchbowl
Honolulu, Hawaii, United States
Northwestern University
Evanston, Illinois, United States
Ascension St. Vincent
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Michigan Medicine
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Northwell Health North Shore University Hospital
Manhasset, New York, United States
NYU Langone Health
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Sanger Heart & Vascular Institute - HCM Clinic
Charlotte, North Carolina, United States
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Ascension Saint Thomas Heart West
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah Health
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Health Care Services
Falls Church, Virginia, United States
VCU Health Downtown Medical Campus
Richmond, Virginia, United States
Carilion Clinic Cardiology
Roanoke, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Providence Sacred Heart Medical Center & Children's Hospital (CPET)
Spokane, Washington, United States
WVU Medicine
Morgantown, West Virginia, United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States
Hospital Italiano de Buenos Aires Juan Domingo Peron
Buenos Aires, , Argentina
ICBA - Instituto Cardiovascular de Buenos Aires
Buenos Aires, , Argentina
Hospital Privado Centro Medico de Cordoba S.A
Córdoba, , Argentina
The Prince Charles Hospital
Chermside, Queensland, Australia
Flinders Medical Centre Cardiology Research
Adelaide, South Australia, Australia
Fiona Stanley Hospital, AHF Unit
Murdoch, , Australia
Instituto D'Or de Pesquisa e Ensino/Cardio Pulmonar da Bahia SA
Ondina, Salvador, Brazil
Fundacao Felice Rocho / Hospital Felicio Rocho
Minas Gerais, , Brazil
NUPEC Cardio / Cardio HVC
Minas Gerais, , Brazil
CLINICOR Clinica Cardiologica LTDA
Ribeirão Preto, , Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, , Brazil
Instituto do Coracao do Hospital de Aguiar
São Paulo, , Brazil
Associacao Lar Sao Francisco de Assis na Providencia de Deus - Hospital Universitario Sao Francisco na Providencia de Deus (HUSF)
São Paulo, , Brazil
Saraiva & Berlinger LTDA - EPP/IPECC - Instituto de Pesquisa Clinical de Campinas
São Paulo, , Brazil
Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo - HCFMRP
São Paulo, , Brazil
Royal Alexandra Hospital
Edmonton, Alberta, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Health Sciences North
Greater Sudbury, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
QEII Health Science Centre (Halifax Infirmary site)
Halifax, , Canada
The 1st Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Peking University First Hospital
Beijing, , China
Fuwai Hospital, CAMS & PUMC
Beijing, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
The First Hospital of Jilin University
Jilin, , China
Zhongda Hospital Southeast University
Nanjin, , China
Shanghai Ruijin Hospital Luwan Branch
Shanghai, , China
Zhongshan Hospital Fudan University
Shanghai, , China
People's Hospital of Liaoning Province
Shenyang, , China
Remin Hospital of Wuhan University
Wuhan, , China
The 1st affi. Hospital of Xi'an Jiaotong University
Xi'an, , China
The 1st affiliated Hospital of Zhengzhou University
Zhenzhou, , China
Aarhus University Hospital
Aarhus, , Denmark
Department of Cardiology Copenhagen University Hospital, Bispebjerg
Copenhagen, , Denmark
Odense University Hospital, Department of Cardiology
Odense, , Denmark
Assistance Publique Hopitaux de Marseille
Marseille, , France
Clinique Du Millenaire
Montpellier, , France
Centre Hospitalier Universitaire De Montpellier
Montpellier, , France
Assistance Publique Hopitaux De Paris
Paris, , France
Assistance Publique Hopitaux de Paris
Paris, , France
Centre Hospitalier Universitaire De Bordeaux
Pessac, , France
Centre Hospitalier Universitaire De Nantes
Saint-Herblain, , France
Hopital Rangueil
Toulouse, , France
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) Medizinische Klinik mit Schwerpunkt Kardiologie
Berlin, , Germany
Herzzentrum der Universitatsmedizin Gottingen
Göttingen, , Germany
Universitaesklinkum Heidelberg Klinik fuer Kardiologie, Angeiologie und Pneumologie
Heidelberg, , Germany
Univeristy Hospital Jena Clinic for Internal Medicine I (Cardiology, Angiology, Internal Intensive Care Medicine)
Jena, , Germany
Evangelismos General Hospital of Athens
Athens, , Greece
"Hippokration" General Hospital of Athens
Athens, , Greece
University General Hospital Attikon
Attiki, , Greece
Onassis Cardiac Surgery Center
Kallithea, , Greece
Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika
Budapest, , Hungary
University of Szeged
Szeged, , Hungary
Landspitali University Hospital
Reykjavik, , Iceland
The Barzilai University Medical Center 2 - Cardiology Division
Ashkelon, , Israel
Division of Cardiology Hadassah Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Ziv Medical Center
Safed, , Israel
Cardiology Department IRCCS San Donato Hospital - University of Milan
San Donato Milanese, Milano, Italy
UOC Cardiologica
Brescia, , Italy
Azienda Ospedaliera Universitaria Careggi pad. 13 Clinica Medica II Plano Cardiologia
Florence, , Italy
Cardiologia Universitaria - UTIC - Riabilitazione Cardiologica Azienda Ospedaliero Universitaria - Ospedali Riuniti
Foggia, , Italy
Unita Operativa di Riabilitazione Cardiologica, Istituto Auxologico Italiano, IRCCS - Auxologico San Luca, Piazzale Brescia, 20
Milan, , Italy
Dipartimento Cardio-toraco- vascolare, ASST Grande Ospedale Metropolitano, NiguardaPiazza Ospedale Maggiore, 3
Milan, , Italy
Dipartimento di Emergenze Cardiovascolari, Medicina Clinica e dell'Invecchiamento, AOU Federico II
Napoli, , Italy
Fondazione Toscana Gabriele Monasterio Per La ricerca Medica e Di Sanita Pubbliga (FTGM) Cardio-Toracic-UOC Cardiology and Cardiovasulcar Medicine San Cataldo Hospital at CNR
Pisa, , Italy
Dipartimento Cardiopolmonare, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele
Roma, , Italy
Azienda Sanitaria Universitaria Giuliano Isontina Trieste SC Cardiologia
Trieste, , Italy
Kyushu University Hospital
Fukuoka, , Japan
Kobe City Medical Center General Hospital
Hyōgo, , Japan
Hyogo Prefectural Harima-Himeii General Medical Center
Hyōgo, , Japan
University of Tsukuba Hospital
Ibaraki, , Japan
SHOWA Medical University Fujigaoka Hospital
Kanagawa, , Japan
Kochi Medical School Hospital
Kochi, , Japan
National Hospital Organization Kyoto Medical Center
Kyoto, , Japan
Mie University Hospital
Mie, , Japan
National University Corporation Tohoku University Tohoku University Hospital
Miyagi, , Japan
Shinshu University Hospital
Nagano, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Osaka General Medical Center
Osaka, , Japan
National Cerebral and Cardiovascular Center
Osaka, , Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka, , Japan
Kitasato University Hospital
Sagamihara, , Japan
Saitama Medical University International Medical Center
Saitama, , Japan
Hamamatsu University Hospital
Shizuoka, , Japan
St. Luke's International Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
The University of Tokyo Hospital
Tokyo, , Japan
Tokyo Women's Medical University Hospital
Tokyo, , Japan
Teikyo University Hospital
Tokyo, , Japan
P. Debyelaan 25
Maastricht, HX, Netherlands
Amsterdam UMC, location AMC
Amsterdam, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Kardio Brynow Sp. z o.o.
Katowice, , Poland
Unidade Local de Saude do Alto Ave, E.P.E
Creixomil, Guimaraes, Portugal
Unidade Local de Saude da Regiao de Aveiro, E.P.E.
Aveiro, , Portugal
Unidade Local de Saude de Sao Jose, E.P.E, - Hospital de Santa Marta Servico de Cardiologia
Lisbon, , Portugal
Hospital da Luz
Lisbon, , Portugal
Hospital CUF Descobertas, Lisbon, Cadiology Department
Lisbon, , Portugal
Complejo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón (HGUGM), Calle del Doctor Esquerdo, 46.
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Universitario Virgen de la Victoria Campus Universitario de Teatinos
Málaga, , Spain
Hospital Clinico Universitario Virgen de la
Murcia, , Spain
Hospital Son Llatzer
Palma de Mallorca, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Alvaro Cunqueiro
Vigo, , Spain
NHS Tayside Ninewells Hospital & Medical School
Dundee, Scotland, United Kingdom
NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, , United Kingdom
Barts Health NHS Trust St Bartholomew's Hospital
London, , United Kingdom
St George's University Hospitals NHS Foundation Trust,
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Oxford Centre for Clinical Magnetic Resonance Research (Ocmr)
Oxford, , United Kingdom
Countries
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Other Identifiers
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2023-505797-15-00
Identifier Type: OTHER
Identifier Source: secondary_id
CY 6033
Identifier Type: -
Identifier Source: org_study_id
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