Hypertrophic Cardiomyopathy Clinical Trial

CY 6022 is an Open Label Study to Collect Long-term Safety and Tolerability Data for Aficamten (CK-3773274)

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 25 Locations for this study

See Locations Near You

Cedars-Sinai Medical Center (Smidt Heart Institute)
Los Angeles California, 90048, United States
UCSF Medical Center
San Francisco California, 94143, 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
Michigan Medicine - University of Michigan
Ann Arbor Michigan, 48109, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, 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
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
The University of Texas Southwestern Medical Center at Dallas
Dallas Texas, 75390, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
University of Virginia Health System University Hospital
Charlottesville Virginia, 22908, United States
Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika
Budapest , 1122, Hungary
Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare
Firenze , 50134, Italy
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
Complejo Hospitalario Universitario A Coruna
Coruña , 15006, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid , 28220, Spain
Glasgow Clinical Research Facility Neuroscience Institute
Glasgow , G51 4, 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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