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Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Sponsor: Cytokinetics
Summary
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
Official title: A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2021-05-06
Completion Date
2028-03
Last Updated
2026-01-22
Healthy Volunteers
No
Interventions
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.
Locations (129)
University of Alabama at Birmingham
Birmingham, Alabama, United States
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
The University of Kansas Medical Center
Kansas City, Kansas, 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
University Hospitals Cleveland Medical Center
Cleveland, 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
Greenville Memorial Hospital
Greenville, 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
Virginia Mason Medical Center
Seattle, Washington, United States
WVUMedicine
Morgantown, West Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Instituto Cardiovascular de Buenos Aires(ICBA)
Buenos Aires, Argentina
Flinders Medical Centre, Cardiology Research
Bedford Park, Australia
The Prince Charles Hospital
Chermside, Australia
Fiona Stanley Hospital, AHF Unit
Murdoch, Australia
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Institut universitaire de cardiologie et de pneumologie de Quebec-Universite Laval
Québec, Quebec, Canada
Royal Alexandra Hospital
Edmonton, Canada
QEII Health Science Centre (Halifax Infirmary site)
Halifax, 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
Odense University Hospital
Odense, Denmark
Hopital de la Timone Service de cardiologie
Marseille, France
Clinique Du Millenaire
Montpellier, France
CHU Montpellier - Hopital Arnaud de Villeneuve
Montpellier, 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
Centre Hospitalier universitaire de Toulouse - Rangueil Hospital
Toulouse, 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
Evangelismos General Hospital of Athens
Athens, Greece
"Hippokration" General Hospital of Athens
Athens, Greece
Onassis Hospital
Athens, Greece
University General Hospital "ATTIKON"
Attiki, Greece
Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika
Budapest, Hungary
Szegedi Tudományegyetem, Belgyógyászati Klinika, Kardiológiai Központ
Szeged, Hungary
Landspitali University Hospital
Reykjavik, Iceland
The Barzilai University Medical Center
Ashkelon, Israel
Hadassah Medical Center- Ein Kerem
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
The Chaim Sheba Medical Center
Ramat Gan, Israel
Ziv Medical Center
Safed, Israel
Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare
Florence, Italy
IRCCS Policlinico San Donato
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliera Universitaria Federico II di Napoli
Naples, 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
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy
Amsterdam UMC
Amsterdam, Netherlands
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
Unidade Local De Saude De Sao Jose E.P.E
Lisbon, Portugal
Hospital Cuf Descobertas S.A.
Lisbon, Portugal
Hospital da Luz
Lisbon, Portugal
Complejo Hospitalario Universitario A Coruna
A Coruña, Spain
Hospital Clinic Barcelona
Barcelona, Spain
Hospital General Universitario Gregorio Marañón (HGUGM)
Madrid, Spain
Hospital Clinico Universitario San Carlos
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Son Llatzer
Palma, Spain
Complexo Hospitalario Universitario De Vigo
Pontevedra, 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
Ninewells Hospital and Medical School
Dundee, 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