A Follow-Up Open-Label Research Evaluation of Sustained Treatment with Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)

Brief description of study

This is an open-label study of CK-3773274 in patients with HCM. The treatment duration is anticipated to be multiple years, concluding when marketing authorization is achieved in the patient’s country or Cytokinetics terminates the study. Approximately 600 patients will be enrolled in this study. After (up to) 56-days of screening, eligible patients will be administered a daily dose of CK-3773274. The highest maximum tolerated dose of CK-3773274 in CY 6022 will be informed by the ongoing conduct of other studies of CK-3773274. Each patient will start at the lowest prespecified dose and undergo echocardiography-guided dose titration to their maximum tolerated dose (not to exceed the highest prespecified dose). Dose adjustment may be made no more frequently than every 2 weeks. Approximately 95 investigative sites worldwide.

Clinical Study Identifier: s22-00565

Principal Investigator: Mark V. Sherrid.

Other Investigators: Daniele Massera, Kristen Marie Rodriguez, Woon Yee Wu, Maria Reuter.

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