Hypertrophic Cardiomyopathy Clinical Trial

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

Summary

The purpose of this study is to collect long-term safety and tolerability data for aficamten (CK-3773274)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Completion of a Cytokinetics trial investigating CK-3773274
LVEF ≥55% at the Screening Visit

Exclusion Criteria:

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 CK-3773274 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) since the completion of a prior trial of CK-3773274.
Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with CK-3773274
History of appropriate ICD shock within 30 days prior to screening

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

600

Study ID:

NCT04848506

Recruitment Status:

Enrolling by invitation

Sponsor:

Cytokinetics

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There are 65 Locations for this study

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Alaska Heart and Vascular Institute
Anchorage Alaska, 99508, 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 District of Columbia, 20010, United States
Holy Cross Hospital / Cardiology Associates
Fort Lauderdale Florida, 33308, United States
Northwestern University
Evanston Illinois, 60208, 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
NYU Langone Health
New York New York, 10016, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York New York, 10032, United States
Sanger Heart & Vascular Institute - HCM Clinic
Charlotte North Carolina, 28204, United States
Duke Cardiology at Southpoint
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Ascension St. John Clinical Research Institute
Tulsa Oklahoma, 76104, 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
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
The University of Texas Southwestern Medical Center at Dallas
Dallas Texas, 75390, United States
Houston Methodist Hospital
Houston Texas, 77030, 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
Il. Interni klinika kardiologie a angiologie
Praha , 128 0, Czechia
Department of Cardiology Aarhus University Hospital
Aarhus , 8200, Denmark
The Heart Center, Department of Cardiology
Copenhagen , 2100, Denmark
Copenhagen University Hospital
Copenhagen , 2400, Denmark
Hopital de la Timone Service de cardiologie
Marseille , 13000, 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
Universitaetsmedizin Goettingen Klinik fur Kardiologie und Pneumologie
Goettigen , 37075, Germany
Universitaetskinikum Wuerzburg Deutsches Zentrum fur Herzinsuffzienz Wurzburg (DZHI) Comprehensive Heart Failure Center (CHFC)
Würzburg , 97078, Germany
Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika
Budapest , 1122, Hungary
The Barzilai University Medical Center
Ashkelon , 78306, Israel
Hadassah Medical Center- Ein Kerem
Jerusalem , 91120, Israel
The Chaim Sheba Medical Center
Ramat Gan , 52656, Israel
Ziv Medical Center
Safed , 13110, Israel
Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare
Firenze , 50134, 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
Maastricht University Medical Center (MUMC)
Maastricht , 6229 , Netherlands
Erasmus Medical Center Department of Cardiology
Rotterdam , 3015, Netherlands
Kardio Brynow S.C.
Katowice , 40-55, Poland
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego - Panstwowy Instytut Badawczy Centrum Zaburzen Rytmu Serca
Warszawa , 04-62, Poland
Centro Hospitalar Do Baixo Vouga, EPE Cardiology Department
Aveiro , 3814-, Portugal
Hospital da Luz
Lisboa , , Portugal
Complejo Hospitalario Universitario A Coruna
Coruña , 15006, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid , 28220, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Madrid , 30120, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario Virgen Macarena-merge
Sevilla , 41009, Spain
Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust
Birmingham , B15 2, United Kingdom
Glasgow Clinical Research Facility Neuroscience Institute
Glasgow , G51 4, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool , L14 3, United Kingdom
St Bartholomew's Hospital
London , EC1A , United Kingdom
St George's University Hospitals NHS Foundation Trust
London , SW17 , United Kingdom
Royal Brompton Hospital
London , SW3 6, United Kingdom
Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford
Oxford , OX3 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

600

Study ID:

NCT04848506

Recruitment Status:

Enrolling by invitation

Sponsor:


Cytokinetics

How clear is this clinincal trial information?

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