Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

Last updated: March 28, 2025
Sponsor: Cytokinetics
Overall Status: Active - Enrolling

Phase

2/3

Condition

Circulation Disorders

Treatment

Aficamten (5 - 20 mg)

CK-3773274 (5 - 20 mg)

Clinical Study ID

NCT04848506
CY 6022
2023-508963-58-00
2020-003571-17
  • Ages 18-85
  • All Genders

Study Summary

The purpose of this study is to collect long-term safety and tolerability data for aficamten.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completion of a Cytokinetics trial investigating aficamten

  • LVEF ≥ 55% at the Screening Visit

Exclusion

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 aninvestigational device or drug < 1 month (or 5 half-lives for drugs, whichever islonger) prior to screening. Other investigational procedures while participating inthis study are not permitted.

  • Since completion of a previous trial of aficamten has:

  • Developed new-onset paroxysmal or permanent atrial fibrillation requiringrhythm restoring treatment (eg, direct-current cardioversion, ablationprocedure, or antiarrhythmic therapy) < 30 days prior to screening. Patient mayre-screen for CY 6022 after 30 days if heart rate (HR) < 100 bpm and/or rhythmis stable > 30 days

  • Undergone septal reduction therapy (surgical myectomy or transcatheter alcoholablation)

  • Had a confirmed LVEF < 40% with an associated dose interruption during participationin a prior study with aficamten

  • History of implantable ICD placement within 30 days prior to screening.

Study Design

Total Participants: 900
Treatment Group(s): 2
Primary Treatment: Aficamten (5 - 20 mg)
Phase: 2/3
Study Start date:
May 06, 2021
Estimated Completion Date:
March 31, 2028

Connect with a study center

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

    Quebec, G1V 4G5
    Canada

    Site Not Available

  • Il. Interni klinika kardiologie a angiologie

    Praha, 128 08
    Czechia

    Site Not Available

  • Department of Cardiology Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Site Not Available

  • Department of Cardiology Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Site Not Available

  • Copenhagen University Hospital

    Copenhagen, 2400
    Denmark

    Site Not Available

  • The Heart Center, Department of Cardiology

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Hopital de la Timone Service de cardiologie

    Marseille, 130005
    France

    Site Not Available

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

    Nantes, 44093
    France

    Site Not Available

  • Hopital Europeen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • Hopital Lariboisiere

    Paris, 75010
    France

    Site Not Available

  • Hopital cardiologique de Haut-Leveque

    Pessac, 33604
    France

    Site Not Available

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

    Rennes, 35033
    France

    Site Not Available

  • Charite-Universitaetsmedizin Berlin

    Berlin, 13353
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Universitaetsmedizin Goettingen Klinik fur Kardiologie und Pneumologie

    Goettigen, 37075
    Germany

    Site Not Available

  • Universitaetsmedizin Goettingen

    Goettingen, 37075
    Germany

    Site Not Available

  • Universitaesklinkum Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • Universitaetsklinikum Jena

    Jena, 07747
    Germany

    Site Not Available

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

    Würzburg, 97078
    Germany

    Site Not Available

  • Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika

    Budapest, 1122
    Hungary

    Site Not Available

  • The Barzilai University Medical Center

    Ashkelon, 7830604
    Israel

    Site Not Available

  • Hadassah Medical Center- Ein Kerem

    Jerusalem, 9112001
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Ziv Medical Center

    Safed, 1311001
    Israel

    Site Not Available

  • Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare

    Firenze, 50134
    Italy

    Site Not Available

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

    Pisa, 56124
    Italy

    Site Not Available

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

    Roma, 00189
    Italy

    Site Not Available

  • Maastricht University Medical Center (MUMC)

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Erasmus Medical Center Department of Cardiology

    Rotterdam, 3015
    Netherlands

    Site Not Available

  • Kardio Brynow S.C.

    Katowice, 40-555
    Poland

    Site Not Available

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

    Warszawa, 04-628
    Poland

    Site Not Available

  • Centro Hospitalar Do Baixo Vouga, EPE Cardiology Department

    Aveiro, 3814-501
    Portugal

    Site Not Available

  • Hospital da Luz

    Lisboa,
    Portugal

    Site Not Available

  • Hospital Clinic Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario A Coruna

    Coruña, 15006
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Arrixaca

    Madrid, 30120
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28220
    Spain

    Site Not Available

  • Hospital Universitario Son Llatzer

    Palma, 07198
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena-merge

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Site Not Available

  • Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW
    United Kingdom

    Site Not Available

  • Glasgow Clinical Research Facility Neuroscience Institute

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London, SW3 6NP
    United Kingdom

    Site Not Available

  • St Bartholomew's Hospital

    London, EC1A 7BE
    United Kingdom

    Site Not Available

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT
    United Kingdom

    Site Not Available

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

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Alaska Heart and Vascular Institute

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Mayo Clinic Building - Phoenix

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • UC San Diego Health - Sulpizio Cardiovascular Center

    La Jolla, California 92037
    United States

    Site Not Available

  • Cedar-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Cedars-Sinai Medical Center (Smidt Heart Institute)

    Los Angeles, California 90048
    United States

    Site Not Available

  • UCSF Medical Center

    San Francisco, California 94143
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Holy Cross Hospital / Cardiology Associates

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Emory Clinic

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Piedmont Fayette Hospital

    Fayetteville, Georgia 30214
    United States

    Site Not Available

  • Northwestern University

    Evanston, Illinois 60208
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Michigan Medicine - University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York 10032
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Sanger Heart & Vascular Institute - HCM Clinic

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Duke Cardiology at Southpoint

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ascension St. John Clinical Research Institute

    Tulsa, Oklahoma 76104
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Providence St. Vincent Medical Center

    Portland, Oregon 97225
    United States

    Site Not Available

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

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • UPMC Presbyterian

    Pittsburg, Pennsylvania 15213
    United States

    Site Not Available

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Ascension Saint Thomas Heart West

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • The University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75390
    United States

    Site Not Available

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

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Intermountain Medical Center

    Murray, Utah 84107
    United States

    Site Not Available

  • University of Utah Health

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Virginia Health System University Hospital

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Inova Health Care Services

    Falls Church, Virginia 22042
    United States

    Site Not Available

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