Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
FOREST-HCM
A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)
3 other identifiers
interventional
900
19 countries
129
Brief Summary
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2021
Longer than P75 for phase_2
129 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedStudy Start
First participant enrolled
May 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
January 22, 2026
January 1, 2025
6.8 years
April 9, 2021
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events observed during dosing of aficamten in patients with HCM
Patient incidence of reported Adverse Events (AEs)
Baseline to End of study, up to 5 years
Secondary Outcomes (11)
Incidence of serious adverse events observed during dosing of aficamten in patients with HCM
Baseline to End of study, up to 5 years
Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of aficamten in patients with HCM
Baseline to End of study, up to 5 years
Long-term effects of aficamten on left ventricular outflow tract gradient (LVOT G) in patients with oHCM
Baseline through the end of participation at 12-24 week intervals
Long-term effects of aficamten on resting LVOT-G
Baseline through the end of participation at 12-24 week intervals
Long-term effects of aficamten on post Valsalva LVOT-G
Baseline through the end of participation at 12-24 week intervals
- +6 more secondary outcomes
Study Arms (1)
Aficamten up to 20 mg
EXPERIMENTALPatients 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.
Interventions
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
You may qualify if:
- Completion of a Cytokinetics trial investigating aficamten
- LVEF ≥ 55% at the Screening Visit
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cytokineticslead
Study Sites (129)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Alaska Heart and Vascular Institute
Anchorage, Alaska, 99508, United States
Mayo Clinic Building - Phoenix
Phoenix, Arizona, 85054, United States
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California, 92037, United States
Cedar-Sinai Medical Center
Los Angeles, California, 90048, United States
Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles, California, 90048, United States
UCSF Medical Center
San Francisco, California, 94143, United States
Yale New Haven Hospital
New Haven, Connecticut, 06519, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Holy Cross Hospital / Cardiology Associates
Fort Lauderdale, Florida, 33308, United States
Emory Clinic
Atlanta, Georgia, 30322, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214, United States
Northwestern University
Evanston, Illinois, 60208, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center)
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Northwell Health North Shore University Hospital
Manhasset, New York, 11030, United States
NYU Langone Health
New York, New York, 10016, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Sanger Heart & Vascular Institute - HCM Clinic
Charlotte, North Carolina, 28204, United States
Duke Cardiology at Southpoint
Durham, North Carolina, 27710, United States
The Linder Research Center at The Christ Hospital
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ascension St. John Clinical Research Institute
Tulsa, Oklahoma, 76104, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia, Pennsylvania, 19104, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Ascension Saint Thomas Heart West
Nashville, Tennessee, 37205, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84107, 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
Inova Health Care Services
Falls Church, Virginia, 22042, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
WVUMedicine
Morgantown, West Virginia, 26506, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Instituto Cardiovascular de Buenos Aires(ICBA)
Buenos Aires, C1428, Argentina
Flinders Medical Centre, Cardiology Research
Bedford Park, 5042, Australia
The Prince Charles Hospital
Chermside, 4032, Australia
Fiona Stanley Hospital, AHF Unit
Murdoch, 6150, Australia
Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012-909, Brazil
Institut universitaire de cardiologie et de pneumologie de Quebec-Universite Laval
Québec, Quebec, G1V 4G5, Canada
Royal Alexandra Hospital
Edmonton, T5H 3V9, Canada
QEII Health Science Centre (Halifax Infirmary site)
Halifax, B3H 3A7, Canada
Il. Interni klinika kardiologie a angiologie
Prague, 128 08, Czechia
Department of Cardiology Aalborg University Hospital
Aalborg, 9000, Denmark
Department of Cardiology Aarhus University Hospital
Aarhus, 8200, Denmark
The Heart Center, Department of Cardiology
Copenhagen, 2100, Denmark
Copenhagen University Hospital
Copenhagen, 2400, Denmark
Odense University Hospital
Odense, 5000, Denmark
Hopital de la Timone Service de cardiologie
Marseille, 130005, France
Clinique Du Millenaire
Montpellier, 340000, France
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
Hopital Lariboisiere
Paris, 75010, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Hopital cardiologique de Haut-Leveque
Pessac, 33604, France
Centre hospitalier universitaire (CHU) de Rennes-Hopital Pontchaillou
Rennes, 35033, France
Centre Hospitalier universitaire de Toulouse - Rangueil Hospital
Toulouse, 31059, France
Charite-Universitaetsmedizin Berlin
Berlin, 13353, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Universitaetsmedizin Goettingen Klinik fur Kardiologie und Pneumologie
Goettigen, 37075, Germany
Universitaesklinkum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Jena
Jena, 07747, Germany
Universitaetskinikum Wuerzburg Deutsches Zentrum fur Herzinsuffzienz Wurzburg (DZHI) Comprehensive Heart Failure Center (CHFC)
Würzburg, 97078, Germany
Evangelismos General Hospital of Athens
Athens, 10676, Greece
"Hippokration" General Hospital of Athens
Athens, 11527, Greece
Onassis Hospital
Athens, 17674, Greece
University General Hospital "ATTIKON"
Attiki, 12462, Greece
Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika
Budapest, 1122, Hungary
Szegedi Tudományegyetem, Belgyógyászati Klinika, Kardiológiai Központ
Szeged, 6725, Hungary
Landspitali University Hospital
Reykjavik, 101, Iceland
The Barzilai University Medical Center
Ashkelon, 7830604, Israel
Hadassah Medical Center- Ein Kerem
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
The Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Ziv Medical Center
Safed, 1311001, Israel
Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare
Florence, 50134, Italy
IRCCS Policlinico San Donato
Milan, 20097, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliera Universitaria Federico II di Napoli
Naples, 80131, Italy
Fondazione toscana Gabriele Monesterio per la ricarca medica Dipartimento Cardiotoracico UOC Cardiologia e Medicina Cardiovasculare Ospedale San Cataldo
Pisa, 56124, Italy
Dipartimento di Medicina Clinica e Molecolare Universita Sapienza di Roma Unita di Terapia Intensiva Cardiologica Azienda Ospedaliero Universitaria Sant'Andrea
Roma, 00189, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, 34149, Italy
Amsterdam UMC
Amsterdam, 1105, Netherlands
Maastricht University Medical Center (MUMC)
Maastricht, 6229 HX, Netherlands
Erasmus Medical Center Department of Cardiology
Rotterdam, 3015, Netherlands
Kardio Brynow S.C.
Katowice, 40-555, Poland
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego - Panstwowy Instytut Badawczy Centrum Zaburzen Rytmu Serca
Warsaw, 04-628, Poland
Centro Hospitalar Do Baixo Vouga, EPE Cardiology Department
Aveiro, 3814-501, Portugal
Unidade Local De Saude De Sao Jose E.P.E
Lisbon, 1150-199, Portugal
Hospital Cuf Descobertas S.A.
Lisbon, 1998-018, Portugal
Hospital da Luz
Lisbon, Portugal
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
Hospital Clinic Barcelona
Barcelona, 08036, Spain
Hospital General Universitario Gregorio Marañón (HGUGM)
Madrid, 28007, Spain
Hospital Clinico Universitario San Carlos
Madrid, 28040, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, 28220, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Madrid, 30120, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Son Llatzer
Palma, 07198, Spain
Complexo Hospitalario Universitario De Vigo
Pontevedra, 36312, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Macarena-merge
Seville, 41009, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW, United Kingdom
Ninewells Hospital and Medical School
Dundee, DD2 1SG, United Kingdom
Glasgow Clinical Research Facility Neuroscience Institute
Glasgow, G51 4TF, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford
Oxford, OX3 9DU, United Kingdom
Related Publications (3)
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.
PMID: 40540987DERIVEDMasri 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. 2026 Feb;14(2):102441. doi: 10.1016/j.jchf.2025.03.008. Epub 2025 Apr 2.
PMID: 40285763DERIVEDMasri 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.
PMID: 39477631DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cytokinetics, MD
Cytokinetics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2021
First Posted
April 19, 2021
Study Start
May 6, 2021
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
January 22, 2026
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share