AzTrials
AzTrials

Symptomatic Non-Obstructive Hypertrophic CardiomyopathyPhase 3ACACIA-HCMNCT06081894

A Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)

A Phase 3 study testing Aficamten in people with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy, run by Cytokinetics at 180 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Aficamten
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
180 sitesin 20 countries
Study dates
31 Aug 2023to Nov 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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.

Trial locations and contacts

180 sites in 20 countries.

180 sites in 20 countries

United States60 sites

  • Michigan Medicine

    Ann Arbor, Michigan, 48109

  • Emory Clinic

    Atlanta, Georgia, 30322

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01803

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Sanger Heart & Vascular Institute - HCM Clinic

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22903

  • The Lindner Research Center at The Christ Hospital

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Northwestern University

    Evanston, Illinois, 60208

  • Inova Health Care Services

    Falls Church, Virginia, 22042

  • Piedmont Heart Institute (CPET)

    Fayetteville, Georgia, 30214

  • Holy Cross Medical Group - Cardiology Associates

    Fort Lauderdale, Florida, 33308

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605-5601

  • The Queen's Medical Center-Punchbowl

    Honolulu, Hawaii, 96813

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Ascension St. Vincent

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • UC San Diego Health - Sulpizio Cardiovascular Center

    La Jolla, California, 92037

  • Keck Medical Center of USC (Outpatient Clinic)

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center (Smidt Heart Institute)

    Los Angeles, California, 90048

  • UCLA Medical Center Cardiovascular Clinic

    Los Angeles, California, 90095

  • University of Wisconsin Hospitals and Clinics

    Madison, Wisconsin, 53792

  • Northwell Health North Shore University Hospital

    Manhasset, New York, 11030

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin/Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • M Health Fairview University of Minnesota Medical Center - East Bank

    Minneapolis, Minnesota, 55455

  • WVU Medicine

    Morgantown, West Virginia, 26506

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Ascension Saint Thomas Heart West

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale New Haven Hospital

    New Haven, Connecticut, 06519

  • NYU Langone Health

    New York, New York, 10016

  • Weill Cornell Medicine

    New York, New York, 10021

  • Mount Sinai Hospital

    New York, New York, 10029

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032

  • Investigational Drug Services, AdventHealth Orlando

    Orlando, Florida, 32804

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • VCU Health Downtown Medical Campus

    Richmond, Virginia, 23298

  • Carilion Clinic Cardiology

    Roanoke, Virginia, 24014

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah Health

    Salt Lake City, Utah, 84132

  • University of California San Francisco

    San Francisco, California, 94143

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Providence Sacred Heart Medical Center & Children's Hospital (CPET)

    Spokane, Washington, 99204

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Westchester Medical Center

    Valhalla, New York, 10595

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Japan22 sites

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Kobe City Medical Center General Hospital

    Hyōgo, 650{047

  • Hyogo Prefectural Harima-Himeii General Medical Center

    Hyōgo, 670-8560

  • University of Tsukuba Hospital

    Ibaraki, 305-8576

  • SHOWA Medical University Fujigaoka Hospital

    Kanagawa, 227-8501

  • Kochi Medical School Hospital

    Kochi, 783-8505

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-0861

  • Mie University Hospital

    Mie, 514-8507

  • National University Corporation Tohoku University Tohoku University Hospital

    Miyagi, 980-8574

  • Shinshu University Hospital

    Nagano, 390-8621

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • Osaka General Medical Center

    Osaka, 558-8558

  • National Cerebral and Cardiovascular Center

    Osaka, 564-8565

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka, 569-8686

  • Kitasato University Hospital

    Sagamihara, 252-0375

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

  • Hamamatsu University Hospital

    Shizuoka, 431-3192

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • Nippon Medical School Hospital

    Tokyo, 113-8603

  • The University of Tokyo Hospital

    Tokyo, 113-8655

  • Tokyo Women's Medical University Hospital

    Tokyo, 162-8666

  • Teikyo University Hospital

    Tokyo, 173-8606

Other trials in Japan

Spain13 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital General Universitario Gregorio Marañón (HGUGM), Calle del Doctor Esquerdo, 46.

    Madrid, 28007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro

    Madrid, 28220

  • Hospital Universitario Virgen de la Victoria Campus Universitario de Teatinos

    Málaga, 29010

  • Hospital Clinico Universitario Virgen de la

    Murcia, 30120

  • Hospital Son Llatzer

    Palma de Mallorca, 07198

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Alvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

China12 sites

  • Peking University First Hospital

    Beijing, 100034

  • Fuwai Hospital, CAMS & PUMC

    Beijing, 100037

  • The 1st Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Guangdong Provincial People's Hospital

    Guangzhou, 519041

  • The First Hospital of Jilin University

    Jilin City, 130031

  • Zhongda Hospital Southeast University

    Nanjin, 210009

  • Shanghai Ruijin Hospital Luwan Branch

    Shanghai, 200020

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • People's Hospital of Liaoning Province

    Shenyang, 110067

  • Remin Hospital of Wuhan University

    Wuhan, 430060

  • The 1st affi. Hospital of Xi'an Jiaotong University

    Xi'an, 710061

  • The 1st affiliated Hospital of Zhengzhou University

    Zhenzhou, 450052

Other trials in China

Italy10 sites

  • UOC Cardiologica

    Brescia, 25123

  • Azienda Ospedaliera Universitaria Careggi pad. 13 Clinica Medica II Plano Cardiologia

    Florence, 50134

  • Cardiologia Universitaria - UTIC - Riabilitazione Cardiologica Azienda Ospedaliero Universitaria - Ospedali Riuniti

    Foggia, 71122

  • Unita Operativa di Riabilitazione Cardiologica, Istituto Auxologico Italiano, IRCCS - Auxologico San Luca, Piazzale Brescia, 20

    Milan, 20149

  • Dipartimento Cardio-toraco- vascolare, ASST Grande Ospedale Metropolitano, NiguardaPiazza Ospedale Maggiore, 3

    Milan, 20162

  • Dipartimento di Emergenze Cardiovascolari, Medicina Clinica e dell'Invecchiamento, AOU Federico II

    Naples, 80131

  • 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, 56124

  • Dipartimento Cardiopolmonare, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele

    Roma, 00163

  • Cardiology Department IRCCS San Donato Hospital - University of Milan

    San Donato Milanese, Milano, 20097

  • Azienda Sanitaria Universitaria Giuliano Isontina Trieste SC Cardiologia

    Trieste, 34148

Other trials in Italy

Brazil9 sites

  • Fundacao Felice Rocho / Hospital Felicio Rocho

    Minas Gerais, 30110-934

  • NUPEC Cardio / Cardio HVC

    Minas Gerais, 30220-140

  • Instituto D'Or de Pesquisa e Ensino/Cardio Pulmonar da Bahia SA

    Ondina, Salvador, 40170-0130

  • CLINICOR Clinica Cardiologica LTDA

    Ribeirão Preto, 14026-900

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, 04012-909

  • Instituto do Coracao do Hospital de Aguiar

    São Paulo, 05403-900

  • Associacao Lar Sao Francisco de Assis na Providencia de Deus - Hospital Universitario Sao Francisco na Providencia de Deus (HUSF)

    São Paulo, 12916-542

  • Saraiva & Berlinger LTDA - EPP/IPECC - Instituto de Pesquisa Clinical de Campinas

    São Paulo, 13060-080

  • Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo - HCFMRP

    São Paulo, 14051-140

Other trials in Brazil

France8 sites

  • Assistance Publique Hopitaux de Marseille

    Marseille, 13005

  • Clinique Du Millenaire

    Montpellier, 34000

  • Centre Hospitalier Universitaire De Montpellier

    Montpellier, 34295

  • Assistance Publique Hopitaux De Paris

    Paris, 75010

  • Assistance Publique Hopitaux de Paris

    Paris, 75015

  • Centre Hospitalier Universitaire De Bordeaux

    Pessac, 33600

  • Centre Hospitalier Universitaire De Nantes

    Saint-Herblain, 44800

  • Hopital Rangueil

    Toulouse, 31059

Other trials in France

United Kingdom7 sites

  • NHS Tayside Ninewells Hospital & Medical School

    Dundee, Scotland, DD1 9SY

  • NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, L14 3PE

  • Barts Health NHS Trust St Bartholomew's Hospital

    London, EC1A 7BE

  • St George's University Hospitals NHS Foundation Trust,

    London, SW17 0QT

  • Royal Brompton Hospital

    London, SW3 6NP

  • Oxford Centre for Clinical Magnetic Resonance Research (Ocmr)

    Oxford, OX3 9DU

Other trials in United Kingdom

Canada5 sites

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • QEII Health Science Centre (Halifax Infirmary site)

    Halifax, B3H 3A7

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • St. Boniface Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Israel5 sites

  • The Barzilai University Medical Center 2 - Cardiology Division

    Ashkelon, 7830604

  • Division of Cardiology Hadassah Medical Center

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Ziv Medical Center

    Safed, 1311001

Other trials in Israel

Portugal5 sites

  • Unidade Local de Saude da Regiao de Aveiro, E.P.E.

    Aveiro, 3814-501

  • Unidade Local de Saude do Alto Ave, E.P.E

    Creixomil, Guimaraes, 4835-044

  • Unidade Local de Saude de Sao Jose, E.P.E, - Hospital de Santa Marta Servico de Cardiologia

    Lisbon, 1150-199

  • Hospital da Luz

    Lisbon, 1500-650

  • Hospital CUF Descobertas, Lisbon, Cadiology Department

    Lisbon, 1998-018

Other trials in Portugal

Germany4 sites

  • Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) Medizinische Klinik mit Schwerpunkt Kardiologie

    Berlin, 13353

  • Herzzentrum der Universitatsmedizin Gottingen

    Göttingen, 37075

  • Universitaesklinkum Heidelberg Klinik fuer Kardiologie, Angeiologie und Pneumologie

    Heidelberg, 69120

  • Univeristy Hospital Jena Clinic for Internal Medicine I (Cardiology, Angiology, Internal Intensive Care Medicine)

    Jena, 07747

Other trials in Germany

Greece4 sites

  • Evangelismos General Hospital of Athens

    Athens, 10676

  • "Hippokration" General Hospital of Athens

    Athens, 11527

  • University General Hospital Attikon

    Attiki, 12462

  • Onassis Cardiac Surgery Center

    Kallithea, 17674

Other trials in Greece

Argentina3 sites

  • Hospital Italiano de Buenos Aires Juan Domingo Peron

    Buenos Aires, 119

  • ICBA - Instituto Cardiovascular de Buenos Aires

    Buenos Aires, C1428

  • Hospital Privado Centro Medico de Cordoba S.A

    Córdoba, X5016KEH

Other trials in Argentina

Australia3 sites

  • Flinders Medical Centre Cardiology Research

    Adelaide, South Australia, 5042

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Fiona Stanley Hospital, AHF Unit

    Murdoch, 6150

Other trials in Australia

Denmark3 sites

  • Aarhus University Hospital

    Aarhus, 8200

  • Department of Cardiology Copenhagen University Hospital, Bispebjerg

    Copenhagen, 2400

  • Odense University Hospital, Department of Cardiology

    Odense, 5000

Other trials in Denmark

Netherlands3 sites

  • Amsterdam UMC, location AMC

    Amsterdam, 1105

  • P. Debyelaan 25

    Maastricht, HX, 6229

  • Erasmus University Medical Center

    Rotterdam, 3015

Other trials in Netherlands

Hungary2 sites

  • Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika

    Budapest, 1122

  • University of Szeged

    Szeged, 6725

Other trials in Hungary

Iceland1 site

  • Landspitali University Hospital

    Reykjavik, 101

Other trials in Iceland

Poland1 site

  • Kardio Brynow Sp. z o.o.

    Katowice, 40-555

Other trials in Poland

About this study

Official title: 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.

Being tested
Aficamten, Placebo
Keywords
CK-3773274, CK-274, Aficamten, Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy, nHCM, ACACIA-HCM, ACACIA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AficamtenDrug

    Oral Tablet

  • PlaceboDrug

    Oral Tablet

Study groups in NCT06081894
Study groupRoleWhat they receive
AficamtenExperimentalParticipants 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.
Receives: Drug: Aficamten
PlaceboPlacebo comparatorParticipants in this arm will receive placebo, for up to 72 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)

    Effect of aficamten compared with placebo on participant health status

    Measured: Baseline to Week 36

  2. Change in pVO2

    Effect of aficamten compared with placebo on maximal exercise capacity

    Measured: Baseline to Week 36

Secondary outcomes (5)

  1. 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

    Measured: Baseline to Week 36

  2. Proportion of participants with ≥ 1 class improvement in New York Heart Association (NYHA) Functional Class

    Effect of aficamten compared with placebo on NYHA Functional Classification

    Measured: Baseline to Week 36

  3. Change in N-terminal prohormone brain natriuretic peptide (NT-proBNP)

    Effect of aficamten compared with placebo on a biomarker of cardiac wall stress

    Measured: Baseline to Week 36

  4. Change in Left Atrial Volume Index (LAVI) in participants without atrial fibrillation or flutter at baseline on ECG

    Effect of aficamten compared with placebo on echocardiographic measures of structural remodeling

    Measured: Baseline to Week 36

  5. Time to first cardiovascular (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)

    Measured: Baseline to End of Study, Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2023
  2. Study start31 Aug 2023
  3. Primary completion31 Aug 2026
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06081894
Sponsor's protocol ID
CY 6033
Other IDs
2023-505797-15-00, 2023
Acronym
ACACIA-HCM
Status last verified
Sep 2026
First submitted
31 Aug 2023
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hegde SM, Wang X, Bhatia A, Pena-Pena ML, Sherrid MV, Figueiredo EL, Arad M, Barriales-Villa R, Choudhury L, Claggett BL, Coats CJ, de Barros Correia E, Costabel JP, Elliott PM, Silva Enciso JE, Garcia-Pavia P, Ge J, Ho CY, Lakdawala NK, Lewis GD, Maron MS, Martinez MW, Masri A, Maurer MS, Michels M, Mitter SS, Pino Moreno JE, Nagy V, Olivotto I, Owens AT, Poulsen SH, Rader F, Rowin EJ, Ruda M, Schulze PC, Sikand N, Spertus JA, Zhao X, Divanji PH, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Salazar-Mendiguchia J, Wohltman A, Zhuo S, Solomon SD; ACACIA-HCM Investigators. Effect of Aficamten on Cardiac Structure and Function in Patients with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy. Circulation. 2026 Aug 29. doi: 10.1161/CIRCULATIONAHA.126.082343. Online ahead of print.

    PubMed 42667274

  • Masri A, Maron MS, Bhatia A, Pena-Pena ML, Sherrid MV, Figueiredo EL, Arad M, Barriales-Villa R, Choudhury L, Claggett BL, Coats CJ, Correia EB, Costabel JP, Elliott PM, Silva Enciso JE, Garcia-Pavia P, Ge J, Hegde SM, Lewis GD, Lopes RD, Martinez MW, Maurer MS, Miao ZM, Michels M, Mitter SS, Pino Moreno JE, Olivotto I, Owens AT, Poulsen SH, Rader F, Rowin EJ, Schulze PC, Sepp R, Sikand N, Solomon SD, Spertus JA, Teale C Sr, Zhao X, Divanji PH, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Salazar-Mendiguchia J, Wohltman A, Zhuo S, Ho CY; ACACIA-HCM Investigators. Aficamten for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy. N Engl J Med. 2026 Aug 28. doi: 10.1056/NEJMoa2603021. Online ahead of print.

    PubMed 42663312

  • Maron MS, Masri A, Bhatia A, Pena-Pena ML, Sherrid MV, Figueiredo EL, Arad M, Choudhury L, Claggett BL, Coats CJ, de Barros Correia E, Costabel JP, Elliott PM, Silva Enciso JE, Ge J, Ho CY, Kulac I, Lewis GD, Martinez MW, Maurer MS, Michels M, Mitter SS, Pino Moreno JE, Olivotto I, Owens AT, Poulsen SH, Rader F, Rowin EJ, Schulze PC, Sepp R, Sikand N, Solomon SD, Spertus JA, Zhao X, Divanji PH, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Salazar-Mendiguchia J, Wohltman A, Zhuo S, Barriales-Villa R; ACACIA-HCM Investigators. Global Efficacy of Aficamten in Nonobstructive Hypertrophic Cardiomyopathy: Results From ACACIA-HCM. Circulation. 2026 Aug 28. doi: 10.1161/CIRCULATIONAHA.126.082026. Online ahead of print.

    PubMed 42663111

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aficamten in people with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy, run by Cytokinetics at 180 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in United States, Japan, Spain, China, Italy and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) (time frame: Baseline to Week 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06081894, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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