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Trial ID CV028-005  |   NCT04572893

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

Summary

  • Phase 2
  • Male and Female Gender icon
  • 18-80
    Age Range
  • 16
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

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Key Eligibility 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: - 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)

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: MYK-491

ASSIGNED INTERVENTION
  • Drug: danicamtiv
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