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Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants

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ClinicalTrials.gov Identifier: NCT04572893
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
MyoKardia, Inc.

Brief Summary:
The purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants .

Condition or disease Intervention/treatment Phase
Primary Familial Dilated Cardiomyopathy Drug: danicamtiv Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Exploratory Study of the Safety and Preliminary Efficacy of Danicamtiv in Stable Ambulatory Patients With Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2024


Arm Intervention/treatment
Experimental: MYK-491
Primary DCM due to MYH7 or TTN Variant
Drug: danicamtiv
Myosin activator
Other Name: MYK-491




Primary Outcome Measures :
  1. Frequency and severity of treatment-emergent adverse events and serious adverse events. [ Time Frame: Up to 22 days, optional extension of up to 96 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Significant structural cardiac abnormalities including valvar dysfunction 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, afterload reduction, or diuretics)
  • Presence of protocol specified laboratory abnormalities at Screening
  • Recent acute coronary syndrome or angina pectoris (<90 days)
  • Recent hospitalization for heart failure (<90 days)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572893


Contacts
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Contact: BMS Medical Information (Use email contact) clinical.trials@bms.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
MyoKardia, Inc.
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Responsible Party: MyoKardia, Inc.
ClinicalTrials.gov Identifier: NCT04572893    
Other Study ID Numbers: MYK-491-006
2019-003626-24 ( EudraCT Number )
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MyoKardia, Inc.:
Primary dilated cardiomyopathy (DCM)
Familial dilated cardiomyopathy (DCM)
Myosin Heavy Chain 7 (MYH7)
Titin (TTN)
MYK-491
danicamtiv
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly
Laminopathies
Genetic Diseases, Inborn