Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM (ACACIA-HCM)

A Phase 3, Multi-Center, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy.

Study Overview

• Status: Active, not recruiting
• Conditions: Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
• Intervention / Treatment: Drug: Placebo; Drug: Aficamten

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 119
    • Hospital Italiano de Buenos Aires Juan Domingo Peron
  • Buenos Aires, Argentina, C1428
    • ICBA - Instituto Cardiovascular de Buenos Aires
  • Córdoba, Argentina, X5016KEH
    • Hospital Privado Centro Medico de Cordoba S.A
• Australia
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital, AHF Unit
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5042
      • Flinders Medical Centre Cardiology Research
• Brazil
  • Minas Gerais, Brazil, 30110-934
    • Fundacao Felice Rocho / Hospital Felicio Rocho
  • Minas Gerais, Brazil, 30220-140
    • NUPEC Cardio / Cardio HVC
  • Ribeirão Preto, Brazil, 14026-900
    • Clinicor Clinica Cardiologica Ltda
  • São Paulo, Brazil, 04012-909
    • Instituto Dante Pazzanese de Cardiologia
  • São Paulo, Brazil, 05403-900
    • Instituto do Coracao do Hospital de Aguiar
  • São Paulo, Brazil, 12916-542
    • Associacao Lar Sao Francisco de Assis na Providencia de Deus - Hospital Universitario Sao Francisco na Providencia de Deus (HUSF)
  • São Paulo, Brazil, 13060-080
    • Saraiva & Berlinger LTDA - EPP/IPECC - Instituto de Pesquisa Clinical de Campinas
  • São Paulo, Brazil, 14051-140
    • Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo - HCFMRP
  • Salvador
    • Ondina, Salvador, Brazil, 40170-0130
      • Instituto D'Or de Pesquisa e Ensino/Cardio Pulmonar da Bahia SA
• Canada
  • Halifax, Canada, B3H 3A7
    • QEII Health Science Centre (Halifax Infirmary site)
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital
  • Ontario
    • Greater Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
• China
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100037
    • FuWai Hospital, CAMS & PUMC
  • Guangzhou, China, 519041
    • Guangdong Provincial People's Hospital
  • Jilin, China, 130031
    • The First Hospital of Jilin University
  • Nanjin, China, 210009
    • Zhongda Hospital Southeast University
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University
  • Shanghai, China, 200020
    • Shanghai Ruijin Hospital Luwan Branch
  • Shenyang, China, 110067
    • People's Hospital of Liaoning Province
  • Wuhan, China, 430060
    • Remin Hospital of Wuhan University
  • Xi'an, China, 710061
    • The 1st affi. Hospital of Xi'an Jiaotong University
  • Zhenzhou, China, 450052
    • The 1st affiliated Hospital of Zhengzhou University
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The 1st Affiliated Hospital of Sun Yat-sen University
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
  • Copenhagen, Denmark, 2400
    • Department of Cardiology Copenhagen University Hospital, Bispebjerg
  • Odense, Denmark, 5000
    • Odense University Hospital, Department of Cardiology
• France
  • Marseille, France, 13005
    • Assistance Publique Hopitaux de Marseille
  • Montpellier, France, 34295
    • Centre Hospitalier Universitaire De Montpellier
  • Montpellier, France, 34000
    • Clinique du Millénaire
  • Paris, France, 75015
    • Assistance Publique Hopitaux de Paris
  • Paris, France, 75010
    • Assistance Publique Hopitaux de Paris
  • Pessac, France, 33600
    • Centre Hospitalier Universitaire De Bordeaux
  • Saint-Herblain, France, 44800
    • Centre Hospitalier Universitaire De Nantes
  • Toulouse, France, 31059
    • Hôpital Rangueil
• Germany
  • Berlin, Germany, 13353
    • Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) Medizinische Klinik mit Schwerpunkt Kardiologie
  • Göttingen, Germany, 37075
    • Herzzentrum der Universitatsmedizin Gottingen
  • Heidelberg, Germany, 69120
    • Universitaesklinkum Heidelberg Klinik fuer Kardiologie, Angeiologie und Pneumologie
  • Jena, Germany, 07747
    • Univeristy Hospital Jena Clinic for Internal Medicine I (Cardiology, Angiology, Internal Intensive Care Medicine)
• Greece
  • Athens, Greece, 10676
    • Evangelismos General Hospital of Athens
  • Athens, Greece, 11527
    • "Hippokration" General Hospital of Athens
  • Attiki, Greece, 12462
    • University General Hospital Attikon
  • Kallithea, Greece, 17674
    • Onassis Cardiac Surgery Center
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika
  • Szeged, Hungary, 6725
    • University of Szeged
• Iceland
  • Reykjavik, Iceland, 101
    • Landspitali University Hospital
• Israel
  • Ashkelon, Israel, 7830604
    • The Barzilai University Medical Center 2 - Cardiology Division
  • Jerusalem, Israel, 9112001
    • Division of Cardiology Hadassah Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Ramat Gan, Israel, 5265601
    • The Chaim Sheba Medical Center
  • Safed, Israel, 1311001
    • Ziv Medical Center
• Italy
  • Brescia, Italy, 25123
    • UOC Cardiologica
  • Florence, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi pad. 13 Clinica Medica II Plano Cardiologia
  • Foggia, Italy, 71122
    • Cardiologia Universitaria - UTIC - Riabilitazione Cardiologica Azienda Ospedaliero Universitaria - Ospedali Riuniti
  • Milan, Italy, 20149
    • Unita Operativa di Riabilitazione Cardiologica, Istituto Auxologico Italiano, IRCCS - Auxologico San Luca, Piazzale Brescia, 20
  • Milan, Italy, 20162
    • Dipartimento Cardio-toraco- vascolare, ASST Grande Ospedale Metropolitano, NiguardaPiazza Ospedale Maggiore, 3
  • Napoli, Italy, 80131
    • Dipartimento di Emergenze Cardiovascolari, Medicina Clinica e dell'Invecchiamento, AOU Federico II
  • Pisa, Italy, 56124
    • 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
  • Roma, Italy, 00163
    • Dipartimento Cardiopolmonare, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele
  • Trieste, Italy, 34148
    • Azienda Sanitaria Universitaria Giuliano Isontina Trieste SC Cardiologia
  • Milano
    • San Donato Milanese, Milano, Italy, 20097
      • Cardiology Department IRCCS San Donato Hospital - University of Milan
• Japan
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Hyōgo, Japan, 650{047
    • Kobe City Medical Center General Hospital
  • Hyōgo, Japan, 670-8560
    • Hyogo Prefectural Harima-Himeii General Medical Center
  • Ibaraki, Japan, 305-8576
    • University of Tsukuba Hospital
  • Kanagawa, Japan, 227-8501
    • SHOWA Medical University Fujigaoka Hospital
  • Kochi, Japan, 783-8505
    • Kochi Medical School Hospital
  • Kyoto, Japan, 612-0861
    • National Hospital Organization Kyoto Medical Center
  • Mie, Japan, 514-8507
    • Mie University Hospital
  • Miyagi, Japan, 980-8574
    • National University Corporation Tohoku University Tohoku University Hospital
  • Nagano, Japan, 390-8621
    • Shinshu University Hospital
  • Osaka, Japan, 558-8558
    • Osaka General Medical Center
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Osaka, Japan, 564-8565
    • National Cerebral and Cardiovascular Center
  • Osaka, Japan, 569-8686
    • Osaka Medical and Pharmaceutical University Hospital
  • Sagamihara, Japan, 252-0375
    • Kitasato University Hospital
  • Saitama, Japan, 350-1298
    • Saitama Medical University International Medical Center
  • Shizuoka, Japan, 431-3192
    • Hamamatsu University Hospital
  • Tokyo, Japan, 162-8666
    • Tokyo Women's Medical University Hospital
  • Tokyo, Japan, 104-8560
    • St. Luke's International Hospital
  • Tokyo, Japan, 173-8606
    • Teikyo University Hospital
  • Tokyo, Japan, 113-8655
    • The University of Tokyo Hospital
  • Tokyo, Japan, 113-8603
    • Nippon Medical School Hospital
• Netherlands
  • Amsterdam, Netherlands, 1105
    • Amsterdam UMC, location AMC
  • Rotterdam, Netherlands, 3015
    • Erasmus University Medical Center
  • HX
    • Maastricht, HX, Netherlands, 6229
      • P. Debyelaan 25
• Poland
  • Katowice, Poland, 40-555
    • Kardio Brynów Sp. z o.o.
• Portugal
  • Aveiro, Portugal, 3814-501
    • Unidade Local de Saúde da Região de Aveiro, E.P.E.
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz
  • Lisbon, Portugal, 1150-199
    • Unidade Local de Saude de Sao Jose, E.P.E, - Hospital de Santa Marta Servico de Cardiologia
  • Lisbon, Portugal, 1998-018
    • Hospital CUF Descobertas, Lisbon, Cadiology Department
  • Guimaraes
    • Creixomil, Guimaraes, Portugal, 4835-044
      • Unidade Local de Saude do Alto Ave, E.P.E
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • Barcelona, Spain, 08025
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28220
    • Hospital Universitario Puerta de Hierro
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón (HGUGM), Calle del Doctor Esquerdo, 46.
  • Murcia, Spain, 30120
    • Hospital Clinico Universitario Virgen de la
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria Campus Universitario de Teatinos
  • Palma de Mallorca, Spain, 07198
    • Hospital Son Llatzer
  • Salamanca, Spain, 37007
    • Hospital Universitario De Salamanca
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Vigo, Spain, 36312
    • Hospital Alvaro Cunqueiro
• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital
  • Liverpool, United Kingdom, L14 3PE
    • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • London, United Kingdom, EC1A 7BE
    • Barts Health NHS Trust St Bartholomew's Hospital
  • London, United Kingdom, SW17 0QT
    • St George's University Hospitals NHS Foundation Trust,
  • Oxford, United Kingdom, OX3 9DU
    • Oxford Centre for Clinical Magnetic Resonance Research (OCMR)
  • Scotland
    • Dundee, Scotland, United Kingdom, DD1 9SY
      • NHS Tayside Ninewells Hospital & Medical School
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego Health - Sulpizio Cardiovascular Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center (Smidt Heart Institute)
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC (outpatient clinic)
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center Cardiovascular Clinic
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • Torrance, California, United States, 90502
      • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale New Haven Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Medical Group - Cardiology Associates
    • Orlando, Florida, United States, 32804
      • Investigational Drug Services, AdventHealth Orlando
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic
    • Fayetteville, Georgia, United States, 30214
      • Piedmont Heart Institute (CPET)
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • The Queen's Medical Center-Punchbowl
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Ascension St. Vincent
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Burlington, Massachusetts, United States, 01803
      • Lahey Hospital & Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Michigan Medicine
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • M Health Fairview University of Minnesota Medical Center - East Bank
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health North Shore University Hospital
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10021
      • Weill Cornell Medicine
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center/New York Presbyterian Hospital
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Sanger Heart & Vascular Institute - HCM Clinic
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Research Center at The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29605-5601
      • Greenville Memorial Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37205
      • Ascension Saint Thomas Heart West
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Health Care Services
    • Richmond, Virginia, United States, 23298
      • VCU Health Downtown Medical Campus
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic Cardiology
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center & Children's Hospital (CPET)
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • WVU Medicine
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospitals and Clinics
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin/Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between 18-85 years of age
• 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:

• Significant valvular heart disease (per Investigator judgment)

  • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Aficamten; Oral Tablet
Placebo Comparator: Placebo; Participants in this arm will receive placebo, for up to 72 weeks.	Drug: Placebo; Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)	Effect of aficamten compared with placebo on participant health status	Baseline to Week 36
Change in pVO2	Effect of aficamten compared with placebo on maximal exercise capacity	Baseline to Week 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in composite of two Z-scores of CPET parameters (pVO2 and VE/VCO2 slope)	Effect of aficamten compared with placebo on global exercise capacity based on maximal and sub-maximal exercise performance	Baseline to Week 36
Proportion of participants with ≥ 1 class improvement in NYHA Functional Class	Effect of aficamten compared with placebo on NYHA Functional Classification	Baseline to Week 36
Change in NT-proBNP	Effect of aficamten compared with placebo on a biomarker of cardiac wall stress	Baseline to Week 36
Time to first CV event	Effect of aficamten compared with placebo on cardiovascular events (ie, CV death, heart transplantation or left ventricular assist device, aborted sudden cardiac death, non-fatal stroke, heart failure hospitalization, or cardiac arrhythmia (atrial fibrillation or ventricular tachyarrhythmia) requiring treatment or hospitalization)	Baseline to End of Study, Week 72
Change in LAVI in participants without atrial fibrillation or flutter at baseline on ECG	Effect of aficamten compared with placebo on echocardiographic measures of structural remodeling	Baseline to Week 36

Collaborators and Investigators

• Sponsor: Cytokinetics
• Collaborators: Sanofi; Bayer
• Investigators: Study Director: Cytokinetics MD, Cytokinetics

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: CK-3773274; CK-274; Aficamten; nHCM; Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy; ACACIA-HCM; ACACIA
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
• Other Study ID Numbers: CY 6033; 2023-505797-15-00 (Other Identifier: EU CTR Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No