Overview
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
Principal investigator
Eligibility criteria
Inclusion Criteria:
* Completion of a Cytokinetics trial investigating aficamten
* 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 aficamten 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)
* Had a confirmed LVEF \< 40% with an associated dose interruption during participation in a prior study with aficamten
* History of implantable ICD placement within 30 days prior to screening.
* Completion of a Cytokinetics trial investigating aficamten
* 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 aficamten 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)
* Had a confirmed LVEF \< 40% with an associated dose interruption during participation in a prior study with aficamten
* History of implantable ICD placement within 30 days prior to screening.
Participate in this trial
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I'm Interested In ParticipatingFor Referring Providers
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