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New heart drug aficamten aims to boost exercise and quality of life in HCM patients

NCT ID NCT06081894

Symptom relief Sponsor: Cytokinetics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether aficamten, an oral drug, can improve quality of life and exercise capacity in 500 adults with symptomatic non-obstructive hypertrophic cardiomyopathy, a heart condition that makes the heart muscle thick and stiff. Participants receive either aficamten or a placebo daily for several months. The study measures changes in heart-related health status and peak oxygen use during exercise.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aficamten
What this could lead to
If it works, this could provide a new treatment option to ease symptoms and improve daily life for people with non-obstructive hypertrophic cardiomyopathy.
What could go wrong
This is a late-stage trial, but the drug may still fail to show meaningful benefit over placebo. Side effects are possible, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hypertrophic cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Symptomatic non-obstructive hypertrophic cardiomyopathy

Contacts and locations

Locations

  • "Hippokration" General Hospital of Athens

    Athens, 11527, Greece

  • Aarhus University Hospital

    Aarhus, 8200, Denmark

  • Amsterdam UMC, location AMC

    Amsterdam, 1105, Netherlands

  • Ascension Saint Thomas Heart West

    Nashville, Tennessee, 37205, United States

  • Ascension St. Vincent

    Indianapolis, Indiana, 46260, United States

  • Assistance Publique Hopitaux De Paris

    Paris, 75010, France

  • Assistance Publique Hopitaux de Marseille

    Marseille, 13005, France

  • Assistance Publique Hopitaux de Paris

    Paris, 75015, France

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

    São Paulo, 12916-542, Brazil

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

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

    Florence, 50134, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina Trieste SC Cardiologia

    Trieste, 34148, Italy

  • Barts Health NHS Trust St Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CLINICOR Clinica Cardiologica LTDA

    Ribeirão Preto, 14026-900, Brazil

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

    Foggia, 71122, Italy

  • Cardiology Department IRCCS San Donato Hospital - University of Milan

    San Donato Milanese, Milano, 20097, Italy

  • Carilion Clinic Cardiology

    Roanoke, Virginia, 24014, United States

  • Cedars-Sinai Medical Center (Smidt Heart Institute)

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Universitaire De Bordeaux

    Pessac, 33600, France

  • Centre Hospitalier Universitaire De Montpellier

    Montpellier, 34295, France

  • Centre Hospitalier Universitaire De Nantes

    Saint-Herblain, 44800, France

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

    Berlin, 13353, Germany

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinique Du Millenaire

    Montpellier, 34000, France

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006, Spain

  • Department of Cardiology Copenhagen University Hospital, Bispebjerg

    Copenhagen, 2400, Denmark

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

    Milan, 20162, Italy

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

    Roma, 00163, Italy

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

    Naples, 80131, Italy

  • Division of Cardiology Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Emory Clinic

    Atlanta, Georgia, 30322, United States

  • Erasmus University Medical Center

    Rotterdam, 3015, Netherlands

  • Evangelismos General Hospital of Athens

    Athens, 10676, Greece

  • Fiona Stanley Hospital, AHF Unit

    Murdoch, 6150, Australia

  • Flinders Medical Centre Cardiology Research

    Adelaide, South Australia, 5042, Australia

  • 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, Italy

  • Fundacao Felice Rocho / Hospital Felicio Rocho

    Minas Gerais, 30110-934, Brazil

  • Fuwai Hospital, CAMS & PUMC

    Beijing, 100037, China

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605-5601, United States

  • Guangdong Provincial People's Hospital

    Guangzhou, 519041, China

  • Hamamatsu University Hospital

    Shizuoka, 431-3192, Japan

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Herzzentrum der Universitatsmedizin Gottingen

    Göttingen, 37075, Germany

  • Holy Cross Medical Group - Cardiology Associates

    Fort Lauderdale, Florida, 33308, United States

  • Hopital Rangueil

    Toulouse, 31059, France

  • Hospital Alvaro Cunqueiro

    Vigo, 36312, Spain

  • Hospital CUF Descobertas, Lisbon, Cadiology Department

    Lisbon, 1998-018, Portugal

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario Virgen de la

    Murcia, 30120, Spain

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

    Madrid, 28007, Spain

  • Hospital Italiano de Buenos Aires Juan Domingo Peron

    Buenos Aires, 119, Argentina

  • Hospital Privado Centro Medico de Cordoba S.A

    Córdoba, X5016KEH, Argentina

  • Hospital Son Llatzer

    Palma de Mallorca, 07198, Spain

  • Hospital Universitario Puerta de Hierro

    Madrid, 28220, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen de la Victoria Campus Universitario de Teatinos

    Málaga, 29010, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital da Luz

    Lisbon, 1500-650, Portugal

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

    São Paulo, 14051-140, Brazil

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Hyogo Prefectural Harima-Himeii General Medical Center

    Hyōgo, 670-8560, Japan

  • ICBA - Instituto Cardiovascular de Buenos Aires

    Buenos Aires, C1428, Argentina

  • Inova Health Care Services

    Falls Church, Virginia, 22042, United States

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

    Ondina, Salvador, 40170-0130, Brazil

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, 04012-909, Brazil

  • Instituto do Coracao do Hospital de Aguiar

    São Paulo, 05403-900, Brazil

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Investigational Drug Services, AdventHealth Orlando

    Orlando, Florida, 32804, United States

  • Kardio Brynow Sp. z o.o.

    Katowice, 40-555, Poland

  • Keck Medical Center of USC (Outpatient Clinic)

    Los Angeles, California, 90033, United States

  • Kitasato University Hospital

    Sagamihara, 252-0375, Japan

  • Kobe City Medical Center General Hospital

    Hyōgo, 650{047, Japan

  • Kochi Medical School Hospital

    Kochi, 783-8505, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01803, United States

  • Landspitali University Hospital

    Reykjavik, 101, Iceland

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, L14 3PE, United Kingdom

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

    Torrance, California, 90502, United States

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

    Minneapolis, Minnesota, 55455, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Medical College of Wisconsin/Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Michigan Medicine

    Ann Arbor, Michigan, 48109, United States

  • Mie University Hospital

    Mie, 514-8507, Japan

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8, Canada

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • NHS Tayside Ninewells Hospital & Medical School

    Dundee, Scotland, DD1 9SY, United Kingdom

  • NUPEC Cardio / Cardio HVC

    Minas Gerais, 30220-140, Brazil

  • NYU Langone Health

    New York, New York, 10016, United States

  • National Cerebral and Cardiovascular Center

    Osaka, 564-8565, Japan

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-0861, Japan

  • National University Corporation Tohoku University Tohoku University Hospital

    Miyagi, 980-8574, Japan

  • Nippon Medical School Hospital

    Tokyo, 113-8603, Japan

  • Northwell Health North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Odense University Hospital, Department of Cardiology

    Odense, 5000, Denmark

  • Onassis Cardiac Surgery Center

    Kallithea, 17674, Greece

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Osaka General Medical Center

    Osaka, 558-8558, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka, 569-8686, Japan

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586, Japan

  • Oxford Centre for Clinical Magnetic Resonance Research (Ocmr)

    Oxford, OX3 9DU, United Kingdom

  • P. Debyelaan 25

    Maastricht, HX, 6229, Netherlands

  • Peking University First Hospital

    Beijing, 100034, China

  • People's Hospital of Liaoning Province

    Shenyang, 110067, China

  • Piedmont Heart Institute (CPET)

    Fayetteville, Georgia, 30214, United States

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

    Spokane, Washington, 99204, United States

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225, United States

  • QEII Health Science Centre (Halifax Infirmary site)

    Halifax, B3H 3A7, Canada

  • Remin Hospital of Wuhan University

    Wuhan, 430060, China

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9, Canada

  • Royal Brompton Hospital

    London, SW3 6NP, United Kingdom

  • SHOWA Medical University Fujigaoka Hospital

    Kanagawa, 227-8501, Japan

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Saitama Medical University International Medical Center

    Saitama, 350-1298, Japan

  • Sanger Heart & Vascular Institute - HCM Clinic

    Charlotte, North Carolina, 28204, United States

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

    São Paulo, 13060-080, Brazil

  • Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika

    Budapest, 1122, Hungary

  • Shanghai Ruijin Hospital Luwan Branch

    Shanghai, 200020, China

  • Shinshu University Hospital

    Nagano, 390-8621, Japan

  • St George's University Hospitals NHS Foundation Trust,

    London, SW17 0QT, United Kingdom

  • St. Boniface Hospital

    Winnipeg, Manitoba, R2H 2A6, Canada

  • St. Luke's International Hospital

    Tokyo, 104-8560, Japan

  • Teikyo University Hospital

    Tokyo, 173-8606, Japan

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

    Guangzhou, Guangdong, 510080, China

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

    Xi'an, 710061, China

  • The 1st affiliated Hospital of Zhengzhou University

    Zhenzhou, 450052, China

  • The Barzilai University Medical Center 2 - Cardiology Division

    Ashkelon, 7830604, Israel

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • The First Hospital of Jilin University

    Jilin City, 130031, China

  • The Lindner Research Center at The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Prince Charles Hospital

    Chermside, Queensland, 4032, Australia

  • The Queen's Medical Center-Punchbowl

    Honolulu, Hawaii, 96813, United States

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • The University of Tokyo Hospital

    Tokyo, 113-8655, Japan

  • Tokyo Women's Medical University Hospital

    Tokyo, 162-8666, Japan

  • UC San Diego Health - Sulpizio Cardiovascular Center

    La Jolla, California, 92037, United States

  • UCLA Medical Center Cardiovascular Clinic

    Los Angeles, California, 90095, United States

  • UOC Cardiologica

    Brescia, 25123, Italy

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

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

    Aveiro, 3814-501, Portugal

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

    Lisbon, 1150-199, Portugal

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

    Creixomil, Guimaraes, 4835-044, Portugal

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

    Milan, 20149, Italy

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

    Jena, 07747, Germany

  • Universitaesklinkum Heidelberg Klinik fuer Kardiologie, Angeiologie und Pneumologie

    Heidelberg, 69120, Germany

  • University General Hospital Attikon

    Attiki, 12462, Greece

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Szeged

    Szeged, 6725, Hungary

  • University of Tsukuba Hospital

    Ibaraki, 305-8576, Japan

  • University of Utah Health

    Salt Lake City, Utah, 84132, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • University of Wisconsin Hospitals and Clinics

    Madison, Wisconsin, 53792, United States

  • VCU Health Downtown Medical Campus

    Richmond, Virginia, 23298, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • WVU Medicine

    Morgantown, West Virginia, 26506, United States

  • Weill Cornell Medicine

    New York, New York, 10021, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06519, United States

  • Zhongda Hospital Southeast University

    Nanjin, 210009, China

  • Zhongshan Hospital Fudan University

    Shanghai, 200032, China

  • Ziv Medical Center

    Safed, 1311001, Israel