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ENROLLING BY INVITATION
NCT04848506
PHASE2/PHASE3

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

Sponsor: Cytokinetics

View on ClinicalTrials.gov

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

DRUG

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