Symptomatic Hypertrophic Cardiomyopathy
Conditions
Interventions
Experimental Arm
- Aficamten tablets administered orally.
- Patients take daily dose of aficamten (5 to 20 mg). Each patient will start at the lowest prespecified dose and titrate up to their maximum
Sponsors
Medical Affairs
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Completion of a Cytokinetics trial investigating aficamten - Left ventricular ejection fraction (LVEF) greater than or equal to 55% at the Screening Visit
Exclusion criteria
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 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 cardioverter-defibrillator (ICD) placement within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Patient incidence of reported adverse events - Patient incidence of reported serious adverse events - Patient incidence of reported LVEF < 50% | — |
Secondary
| Measure | Time frame |
|---|---|
| For patients with obstructive hypertrophic cardiomyopathy (oHCM) only: - Peak left ventricular outflow tract gradient (LVOT-G) at rest - Proportion of patients with resting LVOT-G < 30 mmHg - Proportion of patients with post-Valsalva LVOT-G < 50 mmHg - Proportion of patients with post-Valsalva LVOT-G < 30 mmHg - Proportion of patients with LVEF greater than or equal to 50%, resting LVOT-G < 30 mmHg, and post-Valsalva LVOT-G < 50 mmHg - Time to first resting LVOT-G < 30 mmHg through last follow-up - Time to first post-Valsalva LVOT-G < 50 mmHg through last follow-up - Time to first post-Valsalva LVOT-G < 30 mmHg through last follow-up - Time to first LVEF greater than or equal to 50%, resting LVOT-G < 30 mmHg, and post-Valsalva LVOT-G < 50 mmHg through last follow-up For overall: - Change from baseline values in N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high sensitivity cardiac troponin I (hs-cTnI) biomarkers through end of participation - Change from baseline to end of participation for the Kansas City Cardiomyopathy Questionnaire (KCCQ) | — |
Countries
Argentina, Australia, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Japan, Netherlands, Poland, Portugal, Spain, United Kingdom, United States
Contacts
Public ContactClinical trial contact
ICON Clinical Research GK
Outcome results
None listed