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Heart drug aficamten tested for Long-Term safety in 900 patients

NCT ID NCT04848506

Disease control 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study follows 900 people with hypertrophic cardiomyopathy who have already taken aficamten in earlier trials. Researchers want to see if the drug is safe and tolerable over a longer period. Participants take aficamten tablets daily, with regular clinic visits to monitor for side effects and heart function.

What this could mean

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

Active substance
Aficamten (CK-3773274)
What this could lead to
If successful, this could confirm aficamten as a safe long-term treatment option for hypertrophic cardiomyopathy, potentially improving symptoms and quality of life.
What could go wrong
This is an open-label extension study, so results may be less reliable than blinded trials. Side effects like reduced heart function (LVEF < 50%) are possible, and long-term benefits are not yet proven.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 900 people

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

Started

May 2021

Expected to finish

Mar 2028

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: * Completion of a Cytokinetics trial investigating aficamten * LVEF ≥ 55% at the Screening Visit Exclusion Criteria: * Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor. * Has participated in another investigational device or drug study or received an investigational device or drug \< 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted. * Since completion of a previous trial of aficamten has: * Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \< 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) \< 100 bpm and/or rhythm is stable \> 30 days * Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) * Had a confirmed LVEF \< 40% with an associated dose interruption during participation in a prior study with aficamten * History of implantable ICD placement within 30 days 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 hypertrophic cardiomyopathy (HCM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    129 sites in 19 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "Hippokration" General Hospital of Athens

    Athens, 11527, Greece

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Alaska Heart and Vascular Institute

    Anchorage, Alaska, 99508, United States

  • Amsterdam UMC

    Amsterdam, 1105, Netherlands

  • Ascension Saint Thomas Heart West

    Nashville, Tennessee, 37205, United States

  • Ascension St. John Clinical Research Institute

    Tulsa, Oklahoma, 76104, United States

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Azienda Ospedaliera Universitaria Federico II di Napoli

    Naples, 80131, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina

    Trieste, 34149, Italy

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHI St. Luke's Health Baylor College of Medicine Medical Center

    Houston, Texas, 77030, United States

  • CHU Montpellier - Hopital Arnaud de Villeneuve

    Montpellier, 34295, France

  • CHU de Nantes Institut Du Thorax et du systeme nerveux Clinique Cardiologique et des Maladies Vasculaires

    Nantes, 44093, France

  • Cedar-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cedars-Sinai Medical Center (Smidt Heart Institute)

    Los Angeles, California, 90048, United States

  • Centre Hospitalier universitaire de Toulouse - Rangueil Hospital

    Toulouse, 31059, France

  • Centre hospitalier universitaire (CHU) de Rennes-Hopital Pontchaillou

    Rennes, 35033, France

  • Centro Hospitalar Do Baixo Vouga, EPE Cardiology Department

    Aveiro, 3814-501, Portugal

  • Charite-Universitaetsmedizin Berlin

    Berlin, 13353, Germany

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinique Du Millenaire

    Montpellier, 340000, 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

  • Complexo Hospitalario Universitario De Vigo

    Pontevedra, 36312, Spain

  • Copenhagen University Hospital

    Copenhagen, 2400, Denmark

  • Department of Cardiology Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Department of Cardiology Aarhus University Hospital

    Aarhus, 8200, Denmark

  • Dipartimento di Medicina Clinica e Molecolare Universita Sapienza di Roma Unita di Terapia Intensiva Cardiologica Azienda Ospedaliero Universitaria Sant'Andrea

    Roma, 00189, Italy

  • Duke Cardiology at Southpoint

    Durham, North Carolina, 27710, United States

  • Emory Clinic

    Atlanta, Georgia, 30322, United States

  • Erasmus Medical Center Department of Cardiology

    Rotterdam, 3015, Netherlands

  • Evangelismos General Hospital of Athens

    Athens, 10676, Greece

  • Fiona Stanley Hospital, AHF Unit

    Murdoch, 6150, Australia

  • Flinders Medical Centre, Cardiology Research

    Bedford Park, 5042, Australia

  • Fondazione toscana Gabriele Monesterio per la ricarca medica Dipartimento Cardiotoracico UOC Cardiologia e Medicina Cardiovasculare Ospedale San Cataldo

    Pisa, 56124, Italy

  • Glasgow Clinical Research Facility Neuroscience Institute

    Glasgow, G51 4TF, United Kingdom

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605, United States

  • Hadassah Medical Center- Ein Kerem

    Jerusalem, 9112001, Israel

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Holy Cross Hospital / Cardiology Associates

    Fort Lauderdale, Florida, 33308, United States

  • Hopital Europeen Georges Pompidou

    Paris, 75015, France

  • Hopital Lariboisiere

    Paris, 75010, France

  • Hopital cardiologique de Haut-Leveque

    Pessac, 33604, France

  • Hopital de la Timone Service de cardiologie

    Marseille, 130005, France

  • Hospital Clinic Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario Virgen de la Arrixaca

    Madrid, 30120, Spain

  • Hospital Cuf Descobertas S.A.

    Lisbon, 1998-018, Portugal

  • Hospital General Universitario Gregorio Marañón (HGUGM)

    Madrid, 28007, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28220, Spain

  • Hospital Universitario Son Llatzer

    Palma, 07198, Spain

  • Hospital Universitario Virgen Macarena-merge

    Seville, 41009, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital da Luz

    Lisbon, Portugal

  • Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • IRCCS Policlinico San Donato

    Milan, 20097, Italy

  • Il. Interni klinika kardiologie a angiologie

    Prague, 128 08, Czechia

  • Inova Health Care Services

    Falls Church, Virginia, 22042, United States

  • Institut universitaire de cardiologie et de pneumologie de Quebec-Universite Laval

    Québec, Quebec, G1V 4G5, Canada

  • Instituto Cardiovascular de Buenos Aires(ICBA)

    Buenos Aires, C1428, Argentina

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, 04012-909, Brazil

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Kardio Brynow S.C.

    Katowice, 40-555, Poland

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805, United States

  • Landspitali University Hospital

    Reykjavik, 101, Iceland

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE, United Kingdom

  • Maastricht University Medical Center (MUMC)

    Maastricht, 6229 HX, Netherlands

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Building - Phoenix

    Phoenix, Arizona, 85054, United States

  • MedStar Washington Hospital Center

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

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Michigan Medicine - University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego - Panstwowy Instytut Badawczy Centrum Zaburzen Rytmu Serca

    Warsaw, 04-628, Poland

  • Ninewells Hospital and Medical School

    Dundee, DD2 1SG, United Kingdom

  • Northwell Health North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Odense University Hospital

    Odense, 5000, Denmark

  • Onassis Hospital

    Athens, 17674, Greece

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford

    Oxford, OX3 9DU, United Kingdom

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214, United States

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225, United States

  • QEII Health Science Centre (Halifax Infirmary site)

    Halifax, B3H 3A7, Canada

  • Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW, United Kingdom

  • Royal Alexandra Hospital

    Edmonton, T5H 3V9, Canada

  • Royal Brompton Hospital

    London, SW3 6NP, United Kingdom

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Sanger Heart & Vascular Institute - HCM Clinic

    Charlotte, North Carolina, 28204, United States

  • Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika

    Budapest, 1122, Hungary

  • St Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT, United Kingdom

  • Szegedi Tudományegyetem, Belgyógyászati Klinika, Kardiológiai Központ

    Szeged, 6725, Hungary

  • The Barzilai University Medical Center

    Ashkelon, 7830604, Israel

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • The Heart Center, Department of Cardiology

    Copenhagen, 2100, Denmark

  • The Linder Research Center at The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Prince Charles Hospital

    Chermside, 4032, Australia

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • The University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390, United States

  • UC San Diego Health - Sulpizio Cardiovascular Center

    La Jolla, California, 92037, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

  • Unidade Local De Saude De Sao Jose E.P.E

    Lisbon, 1150-199, Portugal

  • Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare

    Florence, 50134, Italy

  • Universitaesklinkum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetskinikum Wuerzburg Deutsches Zentrum fur Herzinsuffzienz Wurzburg (DZHI) Comprehensive Heart Failure Center (CHFC)

    Würzburg, 97078, Germany

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Jena

    Jena, 07747, Germany

  • Universitaetsmedizin Goettingen Klinik fur Kardiologie und Pneumologie

    Goettigen, 37075, 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 Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center)

    Ann Arbor, Michigan, 48109, United States

  • University of Utah Health

    Salt Lake City, Utah, 84132, United States

  • University of Virginia Health System University Hospital

    Charlottesville, Virginia, 22908, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • WVUMedicine

    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

  • Ziv Medical Center

    Safed, 1311001, Israel