Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities
About the study
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 or other causalities.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- For MYH7 and TTN cohorts, must have diagnosis of primary DCM (dilated cardiomyopathy), clinically stable and due to probably disease-causing variant of MYH7 or TTN
- 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
Exclusion Criteria:
- Significant structural cardiac abnormalities including valvar dysfunction on Screening transthoracic echo(s)
- 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)
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Primary Familial Dilated Cardiomyopathy
Age (in years)
18 - 80
Phase
Phase 2
Participants needed
40
Est. Completion Date
Jan 3, 2025
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT04572893
Study number
CV028-005
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