Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities
NCT ID: NCT04572893
Last Updated: 2025-05-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
41 participants
INTERVENTIONAL
2020-08-04
2024-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MYK-491
Primary DCM due to MYH7 or TTN Variant or due to other causalities not related to MYH7 or TTN variants
danicamtiv
Myosin activator
Interventions
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danicamtiv
Myosin activator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has adequate acoustic windows for echocardiography
* Maximum of 3 family members with same variant can be enrolled
* For the cohort of primary DCM due to causalities other than MYH7 and TTN, participant must have diagnosis of primary DCM with a cause not related to MYH7 or TTN variants
Exclusion Criteria
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0007
La Jolla, California, United States
Local Institution - 0010
Washington D.C., District of Columbia, United States
Local Institution - 0009
Tampa, Florida, United States
Local Institution - 0002
Chicago, Illinois, United States
Local Institution - 0003
Boston, Massachusetts, United States
Local Institution - 0005
Rochester, Minnesota, United States
Local Institution - 0006
Cleveland, Ohio, United States
Local Institution - 0019
Columbus, Ohio, United States
Local Institution - 0001
Philadelphia, Pennsylvania, United States
Local Institution - 0004
Charleston, South Carolina, United States
Local Institution - 0008
Germantown, Tennessee, United States
Local Institution - 0018
Austin, Texas, United States
Local Institution - 0014
Heidelberg, Baden-Wurttemberg, Germany
Local Institution - 0015
Würzburg, , Germany
Local Institution - 0012
A Coruña, , Spain
Local Institution - 0011
El Palmar, , Spain
Local Institution - 0013
Majadahonda, , Spain
Local Institution - 0016
London, , United Kingdom
Local Institution - 0017
Middlesex, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2019-003626-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV028-005
Identifier Type: -
Identifier Source: org_study_id
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