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

  • STATUS
    Recruiting
  • End date
    Jan 3, 2025
  • participants needed
    24
  • sponsor
    Bristol-Myers Squibb
Updated on 1 July 2022

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.

Details
Condition Primary Familial Dilated Cardiomyopathy
Treatment danicamtiv
Clinical Study IdentifierNCT04572893
SponsorBristol-Myers Squibb
Last Modified on1 July 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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