Symptomatic Hypertrophic Cardiomyopathy thickened heart muscle
Conditions
Interventions
All patients will receive aficamten. Route of administration is oral.
Dosage level(s) up to 20mg once daily (5, 10, 15 or 20 mg).
Sponsors
Cytokinetics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Completion of a Cytokinetics study investigating aficamten. If unable to complete a qualifying study due to circumstances not related to compliance or safety, the Medical Monitor may review and determine eligibility. • LVEF >=55% at the Screening Visit
Exclusion criteria
Exclusion criteria: Exclusion Criteria • Has participated in another investigational device or drug study or received an investigational device or drug 30 days. * Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation). • Has current obstructive coronary artery disease (>70% stenosis documented in one or more arteries) • Has moderate or severe aortic valve stenosis • Had a confirmed LVEF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events observed during dosing of CK-3773274 in patients with HCM Patient. Incidence of reported Adverse Events (AEs). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Incidence of serious adverse events 2. Incidence of left ventricular ejection fraction (LVEF) | — |
Countries
Netherlands
Outcome results
None listed