Título:
Exploratory Study of MYK-491 in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants
Estado de reclutamiento:
Estado se actualizó más recientemente:
October 1, 2020
Fenotipo(s) clínico(s):
Propósito de estudio:
The purpose of this Phase 2a study is to establish safety and tolerability of treatment with MYK-491 in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants.
Intervención / tratamiento:
Drug: danicamtiv
Fase:
Descripción del estudio:
N/A
Tipo de estudio:
Título oficial:
Open-Label Exploratory Study of Oral MYK-491 in Stable Ambulatory Patients With Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants
Fecha de inicio del estudio:
August 19, 2020
Fecha de finalización del estudio:
July 2021
Objetivo(s) principal(es):
Frequency and severity of treatment-emergent adverse events and serious adverse events. [ Time Frame: Up to 22 days ]
Objetivo(s) secundario(s):
N/A
Elegibilidad:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criterios de inclusión:
Has stable primary dilated cardiomyopathy due to either MYH7 or TTN variant
Has adequate acoustic windows for echocardiography
Maximum of 3 family members with same variant can be enrolled
Criterio de exclusión:
- Any significant structural cardiac abnormalities on Screening transthoracic echo(s)
- A pathogenic variant implicated in DCM of another gene other than MYH7 or TTN
- Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, vasodilators [e.g., nesiritide], diuretics), or routinely scheduled ultrafiltration
- Presence of protocol specified laboratory abnormalities at Screening
Sitio(s) de estudio / Ubicacion(es):
- United States, Massachusetts
- Brigham and Women's HospitalRecruiting
- Boston, Massachusetts, United States, 02115
- Contact: Mary Sheehan, RN 617-732-6237
Patrocinadores y Colaboradores:
MyoKardia, Inc.
Investigador(es) principal(es):
Myokardia Medical Information
650-741-0900
medinfo@myokardia.com
Para obtener más información, por favor comuníquese con el Coordinador del estudio:
Contact:
Email:
Phone:
ID de ClinicalTrials.gov:
NCT04572893