Title:
Exploratory Study of MYK-491 in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants
Recruitment Status:
Status Last Updated:
October 1, 2020
Clinical Phenotype(s):
Study Purpose:
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.
Intervention/Treatment:
Drug: danicamtiv
Phase:
Study Description:
N/A
Study Type:
Official Title:
Open-Label Exploratory Study of Oral MYK-491 in Stable Ambulatory Patients With Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants
Study Start Date:
August 19, 2020
Study Completion Date:
July 2021
Primary Objective(s):
Frequency and severity of treatment-emergent adverse events and serious adverse events. [ Time Frame: Up to 22 days ]
Secondary Objective(s):
N/A
Eligibility:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Site(s)/Location(s):
- United States, Massachusetts
- Brigham and Women's HospitalRecruiting
- Boston, Massachusetts, United States, 02115
- Contact: Mary Sheehan, RN 617-732-6237
Sponsors & Collaborators:
MyoKardia, Inc.
Principal Investigator(s):
Myokardia Medical Information
650-741-0900
medinfo@myokardia.com
For more information, please contact the Study Coordinator:
Contact:
Email:
Phone:
ClinicalTrials.gov ID:
NCT04572893