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

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

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

Conditions
-----------------
Symptomatic Hypertrophic Cardiomyopathy (HCM)

Intervention / Treatment
-----------------
* Drug: CK-3773274 (5 - 20 mg)


Participation 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CK-3773274 up to 20 mg<br>Patients in this arm take daily dose of CK-3773274. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose. | Drug: CK-3773274 (5 - 20 mg)<br>* CK-3773274 tablets administered orally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events observed during dosing of CK-3773274 in patients with HCM | Patient incidence of reported Adverse Events (AEs) | Baseline to End of study, up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events observed during dosing of CK-3773274 in patients with HCM | Patient incidence of reported Serious Adverse Events (SAEs) | Baseline to End of study, up to 5 years | 
| Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of CK-3773274 in patients with HCM | Patient incidence of reported LVEF <50% | Baseline to End of study, up to 5 years | 
| Long-term effects of CK-3773274 on left ventricular outflow tract gradient (LVOT G) in patients with oHCM | Peak LVOT-G at rest | Baseline through the end of participation at 12-week intervals | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non obstructive hypertrophic cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy, oHCM, CK-3773274, CK-274, nHCM, HCM, Hypertrophic cardiomyopathy, Aficamten, REDWOOD-OLE, CY 6022, FOREST-HCM, Forest