NCT04848506Enrolling by invitationPhase 2/3
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- First submitted
- 9 Apr 2021
- Start date
- May 2021
- Primary completion date
- Mar 2029
- Lead sponsor
- Cytokinetics
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT04848506
- EU CT number
- 2023-508963-58-00
- EudraCT number
- 2020-003571-17
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 900
- From May 2021 to the primary completion date, Mar 2029
- 143 sites in 19 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- History of implantable ICD placement within 30 days prior to screening.
Lab values
- Had a confirmed LVEF \< 40% with an associated dose interruption during participation in a prior study with aficamten
Who the study is looking for
- Completion of a Cytokinetics trial investigating aficamten
- LVEF ≥ 55% at the Screening Visit
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (143)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Cardiovascular de Buenos Aires (ICBA) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Flinders Medical Centre, Cardiology Research Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| The Prince Charles Hospital Coordinator of this site? Confirm its status | Chermside | Australia | Unknown status |
| Fiona Stanley Hospital, AHF Unit Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Nucleo de Pesquisa Clinica NUPEC Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Associacao Lar Sao Francisco de Assis na Providencia de Deus - Hospital Universitario Sao Francisco na Providencia de Deus (HUSF) Coordinator of this site? Confirm its status | Bragança Paulista | Brazil | Unknown status |
| IPECC - Instituto de Pesquisa Clínica de Campinas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Centro Avancado de Pesquisa-Estudo para-Diagnostico-CAPED Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
| Universidade de Sao Paulo (USP) Hospital das Clinicas da Faculdade de Medicina Instituto do Coracao (InCor) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto Dante Pazzanese de Cardiologia Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Royal Alexandra Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| QEII Health Science Centre (Halifax Infirmary site) Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| St. Boniface General Hospital Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Kerckhoff-Klinik GmbH Coordinator of this site? Confirm its status | Bad Nauheim | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Copenhagen University Hospital Coordinator of this site? Confirm its status | Copenhagen Nv | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Complexo Hospitalario Universitario De Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Clinique du Millenaire Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 15 | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Ninewells Hospital and Medical School Coordinator of this site? Confirm its status | Dundee | United Kingdom | Unknown status |
| Glasgow Clinical Research Facility Neuroscience Institute Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Liverpool Heart and Chest Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St. George's University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Brompton Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Evaggelismos Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Hippokration Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Onassis Cardiac Surgery Center Coordinator of this site? Confirm its status | Kallithea | Greece | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest XII | Hungary | Recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Recruiting |
| The Barzilai University Medical Center Coordinator of this site? Confirm its status | Ashkelon | Israel | Unknown status |
| Hadassah Medical Center - Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| The Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Ziv Medical Center Coordinator of this site? Confirm its status | Safed | Israel | Unknown status |
| Landspitali Coordinator of this site? Confirm its status | Reykjavik | Iceland | Recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Fondazione Toscana Gabriele Monasterio Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Sant Andre Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Policlinico San Donato S.p.A. Coordinator of this site? Confirm its status | San Donato Milanese | Italy | Recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
| Academisch Medisch Centrum Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Universiteit Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Kardio Brynów Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Unidade Local De Saude Da Regiao De Aveiro E.P.E. Coordinator of this site? Confirm its status | Aveiro | Portugal | Recruiting |
| Hospital da Luz, S.A Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Sao Jose E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Hospital Cuf Descobertas S.A. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Alaska Heart and Vascular Institute Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center) Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Michigan Medicine - University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Emory Clinic Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Lahey Hospital & Medical Center Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Sanger Heart & Vascular Institute, Atrium Health Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University of Virginia Health System University Hospital Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The Linder Research Center at The Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The University of Texas Southwestern Medical Center at Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Duke Cardiology at Southpoint Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Inova Health Care Services Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
| Piedmont Fayette Hospital Coordinator of this site? Confirm its status | Fayetteville | United States | Unknown status |
| Holy Cross Hospital / Cardiology Associates Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Greenville Memorial Hospital Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| The Queen's Medical Center Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| CHI St. Luke's Health Baylor College of Medicine Medical Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| The University of Iowa Hospitals & Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Saint Luke's Hospital of Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| The University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| UC San Diego Health-Sulpizio Cardiovascular Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Cedar Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Cedars-Sinai Medical Center (Smidt Heart Institute) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| UCLA Health System - UCLA Cardiovascular Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Northwell Health North Shore University Hospital Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| Aurora St. Luke's Medical Center Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| WVUMedicine Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Intermountain Medical Center Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
| Ascension Saint Thomas Heart West Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center/New York-Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine) Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic Building-Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| UPMC Presbyterian Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Providence St. Vincent Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University Of Utah Health Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| UCSF Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Virginia Mason Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Ascension St. John Clinical Research Institute Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Westchester Medical Center Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
Related publications
- Long-term impact of aficamten on patient-reported outcome measures in obstructive hypertrophic cardiomyopathy: results from FOREST-HCM.Eur J Heart Fail · 2026 · PMID 42544039
- Aficamten is associated with improvements in cardiac mechanics in obstructive hypertrophic cardiomyopathy: Results from FOREST-HCM.Prog Cardiovasc Dis · 2026 · PMID 42641848
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