Symptomatic Hypertrophic Cardiomyopathy (HCM)
Conditions
Keywords
Obstructive Hypertrophic Cardiomyopathy, oHCM, CK-3773274, CK-274, Non obstructive hypertrophic cardiomyopathy, nHCM, HCM, Hypertrophic cardiomyopathy, Aficamten, REDWOOD-OLE, CY 6022, FOREST-HCM, Forest
Brief summary
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
Interventions
DRUGAficamten (5 - 20 mg)
Aficamten tablets administered orally. During titration phase, clinic visits will occur approximately every 2-6 weeks. In the maintenance phase clinic visits will occur every 24 weeks, with safety check-in occurring every 12 weeks between visits by phone or, if desirable, in the clinic.
Sponsors
Cytokinetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events observed during dosing of aficamten in patients with HCM | Baseline to End of study, up to 5 years | Patient incidence of reported Adverse Events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serious adverse events observed during dosing of aficamten in patients with HCM | Baseline to End of study, up to 5 years | Patient incidence of reported Serious Adverse Events (SAEs) |
| Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of aficamten in patients with HCM | Baseline to End of study, up to 5 years | Patient incidence of reported LVEF \<50% |
| Long-term effects of aficamten on left ventricular outflow tract gradient (LVOT G) in patients with oHCM | Baseline through the end of participation at 12-24 week intervals | Peak LVOT-G at rest; applicable only to patients with oHCM |
| Long-term effects of aficamten on resting LVOT-G | Baseline through the end of participation at 12-24 week intervals | Proportion of patients with resting LVOT-G \< 30 mmHg; applicable only to patients with oHCM |
| Long-term effects of aficamten on post Valsalva LVOT-G | Baseline through the end of participation at 12-24 week intervals | Proportion of patients with post-Valsalva LVOT-G \< 50 mmHg; applicable only to patients with oHCM |
| Long-term effects of aficamten on left ventricular ejection fraction (LVEF) and post-Valsalva LVOT-G | Baseline through the end of participation at 12-24 week intervals | Proportion of patients with LVEF ≥ 50%, resting LVOT-G \< 30 mmHg, and post-Valsalva LVOT-G \< 50 mmHg; applicable only to patients with oHCM |
| Long-term effects of aficamten on time to first resting LVOT-G < 30 mmHg through last follow-up | Time to the following event through last follow-up, up to 5 years | Applicable only to patients with oHCM |
| Long-term effects of aficamten on time to first post-Valsalva LVOT-G < 50 mmHg through last follow-up | Time to the following event through last follow-up, up to 5 years | Applicable only to patients with oHCM |
| Long-term effects of aficamten on time to first post-Valsalva LVOT-G < 30 mmHg through last follow-up | Time to the following event through last follow-up, up to 5 years | Applicable only to patients with oHCM |
| Long-term effects of aficamten on time to first LVEF ≥ 50%, resting LVOT-G < 30 mmHg, and post-Valsalva LVOT-G < 50 mmHg through last follow-up | Time to the following event through last follow-up, up to 5 years | Applicable only to patients with oHCM |
Countries
Argentina, Australia, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORCytokinetics, MD
Cytokinetics
Outcome results
None listed