Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
NCT ID: NCT04848506
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2/PHASE3
900 participants
INTERVENTIONAL
2021-05-06
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aficamten up to 20 mg
Patients in this arm take daily dose of aficamten. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.
Aficamten (5 - 20 mg)
Aficamten tablets administered orally. During titration phase, clinic visits will occur approximately every 2-6 weeks. In the maintenance phase clinic visits will occur every 24 weeks, with safety check-in occurring every 12 weeks between visits by phone or, if desirable, in the clinic.
Interventions
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Aficamten (5 - 20 mg)
Aficamten tablets administered orally. During titration phase, clinic visits will occur approximately every 2-6 weeks. In the maintenance phase clinic visits will occur every 24 weeks, with safety check-in occurring every 12 weeks between visits by phone or, if desirable, in the clinic.
Eligibility Criteria
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Inclusion Criteria
* LVEF ≥ 55% at the Screening Visit
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Cytokinetics
INDUSTRY
Responsible Party
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Principal Investigators
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Cytokinetics, MD
Role: STUDY_DIRECTOR
Cytokinetics
Locations
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Alaska Heart and Vascular Institute
Anchorage, Alaska, United States
Mayo Clinic Building - Phoenix
Phoenix, Arizona, United States
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California, United States
Cedar-Sinai Medical Center
Los Angeles, California, United States
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles, California, United States
UCSF Medical Center
San Francisco, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Holy Cross Hospital / Cardiology Associates
Fort Lauderdale, Florida, United States
Emory Clinic
Atlanta, Georgia, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Northwestern University
Evanston, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, United States
University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center)
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Northwell Health North Shore University Hospital
Manhasset, New York, United States
NYU Langone Health
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Sanger Heart & Vascular Institute - HCM Clinic
Charlotte, North Carolina, United States
Duke Cardiology at Southpoint
Durham, North Carolina, United States
The Linder Research Center at The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ascension St. John Clinical Research Institute
Tulsa, Oklahoma, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Ascension Saint Thomas Heart West
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah Health
Salt Lake City, Utah, United States
University of Virginia Health System University Hospital
Charlottesville, Virginia, United States
Inova Health Care Services
Falls Church, Virginia, United States
Instituto Dante Pazzanese de Cardiologia
São Paulo, , Brazil
Institut universitaire de cardiologie et de pneumologie de Quebec-Universite Laval
Québec, Quebec, Canada
Il. Interni klinika kardiologie a angiologie
Prague, , Czechia
Department of Cardiology Aalborg University Hospital
Aalborg, , Denmark
Department of Cardiology Aarhus University Hospital
Aarhus, , Denmark
The Heart Center, Department of Cardiology
Copenhagen, , Denmark
Copenhagen University Hospital
Copenhagen, , Denmark
Hopital de la Timone Service de cardiologie
Marseille, , France
CHU de Nantes Institut Du Thorax et du systeme nerveux Clinique Cardiologique et des Maladies Vasculaires
Nantes, , France
Hopital Lariboisiere
Paris, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital cardiologique de Haut-Leveque
Pessac, , France
Centre hospitalier universitaire (CHU) de Rennes-Hopital Pontchaillou
Rennes, , France
Charite-Universitaetsmedizin Berlin
Berlin, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsmedizin Goettingen Klinik fur Kardiologie und Pneumologie
Goettigen, , Germany
Universitaesklinkum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Universitaetskinikum Wuerzburg Deutsches Zentrum fur Herzinsuffzienz Wurzburg (DZHI) Comprehensive Heart Failure Center (CHFC)
Würzburg, , Germany
Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika
Budapest, , Hungary
The Barzilai University Medical Center
Ashkelon, , Israel
Hadassah Medical Center- Ein Kerem
Jerusalem, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Ziv Medical Center
Safed, , Israel
Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare
Florence, , Italy
Fondazione toscana Gabriele Monesterio per la ricarca medica Dipartimento Cardiotoracico UOC Cardiologia e Medicina Cardiovasculare Ospedale San Cataldo
Pisa, , Italy
Dipartimento di Medicina Clinica e Molecolare Universita Sapienza di Roma Unita di Terapia Intensiva Cardiologica Azienda Ospedaliero Universitaria Sant'Andrea
Roma, , Italy
Maastricht University Medical Center (MUMC)
Maastricht, , Netherlands
Erasmus Medical Center Department of Cardiology
Rotterdam, , Netherlands
Kardio Brynow S.C.
Katowice, , Poland
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego - Panstwowy Instytut Badawczy Centrum Zaburzen Rytmu Serca
Warsaw, , Poland
Centro Hospitalar Do Baixo Vouga, EPE Cardiology Department
Aveiro, , Portugal
Hospital da Luz
Lisbon, , Portugal
Complejo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Madrid, , Spain
Hospital Universitario Son Llatzer
Palma, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen Macarena-merge
Seville, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Glasgow Clinical Research Facility Neuroscience Institute
Glasgow, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford
Oxford, , United Kingdom
Countries
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References
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Saberi S, Abraham TP, Choudhury L, Barriales-Villa R, Elliott PM, Nassif ME, Oreziak A, Owens AT, Tower-Rader A, Rader F, Garcia-Pavia P, Olivotto I, Coats CJ, Fifer MA, Sherrid MV, Solomon SD, Watkins H, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Melloni C, Meng L, Wei J, Maron MS, Masri A; FOREST-HCM Steering Committee and Investigators. Aficamten Treatment for Symptomatic Obstructive Hypertrophic Cardiomyopathy: 48-Week Results From FOREST-HCM. JACC Heart Fail. 2025 Aug;13(8):102496. doi: 10.1016/j.jchf.2025.03.040. Epub 2025 Jun 19.
Masri A, Maron MS, Abraham TP, Nassif ME, Barriales-Villa R, Bilen O, Coats CJ, Elliott P, Garcia-Pavia P, Massera D, Olivotto I, Oreziak A, Owens AT, Saberi S, Solomon SD, Tower-Rader A, Heitner SB, Jacoby DL, Melloni C, Wei J, Sherrid MV; REDWOOD-HCM, SEQUOIA-HCM, and FOREST-HCM Investigators. Concomitant Aficamten and Disopyramide in Symptomatic Obstructive Hypertrophic Cardiomyopathy. JACC Heart Fail. 2025 Apr 2:102441. doi: 10.1016/j.jchf.2025.03.008. Online ahead of print.
Masri A, Choudhury L, Barriales-Villa R, Elliott P, Maron MS, Nassif ME, Oreziak A, Owens AT, Saberi S, Tower-Rader A, Rader F, Garcia-Pavia P, Olivotto I, Nagueh SF, Wang A, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Melloni C, Meng L, Wei J, Sherrid MV, Abraham TP; FOREST-HCM Investigators. Standard-of-Care Medication Withdrawal in Patients With Obstructive Hypertrophic Cardiomyopathy Receiving Aficamten in FOREST-HCM. J Am Coll Cardiol. 2024 Nov 5;84(19):1839-1849. doi: 10.1016/j.jacc.2024.09.002.
Other Identifiers
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2020-003571-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508963-58-00
Identifier Type: OTHER
Identifier Source: secondary_id
CY 6022
Identifier Type: -
Identifier Source: org_study_id