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

Por invitaciónFase 3ClinicalTrials.gov

ID: NCT04848506Tipo: INTERVENTIONALInicio: 6 de may de 2021Fin estimado: 1 de mar de 2028

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to collect long-term safety and tolerability data for aficamten.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Completion of a Cytokinetics trial investigating aficamten
LVEF ≥ 55% at the Screening Visit

Criterios de exclusión

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.

Intervenciones

drug

Aficamten (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.

Ubicaciones

Instituto Cardiovascular de Buenos Aires(ICBA)

Buenos Aires, Argentina

Patrocinadores

PrincipalCytokinetics

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Follow-Up, Open-Label, Research Evaluation of Sustained... | EligiMed